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). The certified copy has been filed in parent Application No. DE 202021103530.7, filed on 07/01/2021.
Response to Amendment
The Amendments filed 10/23/2025 have been entered.
Claims 1 and 3 have thereby been amended.
Claim 10 has been cancelled.
Claims 1-9 and 11 are being examined in this office action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “without aligning the base plate in the drive head lower shell,” but this limitation is rendered indefinite as it is unclear from the disclosure what is meant by this and how the upper shell would close and seal the interior space without aligning the base plate located within that interior space. Furthermore, it is not stated what components are or are not “aligned” with the base plate, and how that alignment is defined in this context. For the purposes of examination, this claim limitation is interpreted to mean that there is an additional component present which is responsible for forming the fluid-tight seal when the upper and lower shells are assembled.
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 1-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kamen (US 10722645) in view of Pippin (US 20190351132) in further view of Liu (CN 112807528).
Regarding claim 1, Kamen discloses a medical fluid pump (501) comprising: a housing (502); a drive arm that is tubular or rod-shaped (524); a drive head (522) linearly movable toward the housing via the drive arm (linear movement of 522 toward pump body housing shown in Figs. 32-33); and a metallic support structure comprising a plate (upper and lower projections 633, and plate 649, see annotated Fig. 40 below, and 651 and projection “A” from 600 seen in annotated Fig. 38 below), and a base plate (see annotated Fig. 44 below), the drive head having a drive head lower shell (602) and a drive head upper shell (600), the metallic support structure being accommodated in an interior space formed by the drive head lower shell and the drive head upper shell (Figs. 40 and 44, metallic support structure elements are all in the interior), the metallic support structure being directly fixed to the drive head lower shell and to a free end portion of the drive arm (649 is fixed to the lower shell: col. 57, line 66 – col. 58, line 7; and upper and lower projections 633 are fixed to the lower shell as well as arm 524: col. 58, lines 22-24), the drive head lower shell and the metallic support structure having electronic components disposed therebetween on the base plate (see annotated Fig. 44 below: the electronic components 598 disposed on the base plate between portions of the metallic structure and portions of the lower shell). Although Kamen discloses lower and upper drive head shells, Kamen fails to disclose the orientation of these shells such that the lower shell faces the housing 502 of body 501, and the upper shell is faces away from the housing 502 of body 501, as well as an additional element for their sealing without aligning of the base plate.
Pippin teaches an analogous syringe pump with a drive head (400) that comprises a drive head lower shell facing the housing (401; Figs. 4C and 9B) and a drive head upper shell turned away from the housing (402; Figs. 4C and 1B). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drive head shells of Kamen by changing their orientation to that taught by Pippin as a rearrangement of the parts (see MPEP 2144.04 VI.C.), in order to form a single, better seal of the drive head housing around the shaft of the drive arm. Pippin also teaches that, as best understood (see the claim interpretation in Claim Rejections - 35 USC § 112 above), the drive head upper shell closes and fluid-tightly seals the interior space without aligning the base plate in the drive head lower shell (Pippin: Fig. 4C: gasket 418 forms the seal between the lower and upper shells when they are attached; para. [0081], sentences 1-2). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated the gasket taught by Pippin into the Kamen-Pippin combination in order to form a fluid-tight seal between the upper and lower shells to prevent liquid from entering the drive head.
Although both Kamen and Pippin teach the general housing of the device being metallic (Kamen: col. 13, lines 66-67; Pippin: para. [0062], last sentence), Kamen in view of Pippin does not explicitly teach the inner support structures of the drive head shells being metal. Liu teaches an analogous syringe pump with a drive head (20) that comprises a metallic inner bracket plate structure for providing support and fixing other components too (28; page 15 of translation, fourth paragraph from the bottom describing 28 being metallic). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the support structure components of the Kamen-Pippin device by incorporating the Liu teaching to make them metal in order to provide a more durable material that can withstand greater forces for the pump components they support.
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Annotated Fig. 40, Kamen
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Annotated Fig. 44, Kamen
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Annotated Fig. 38, Kamen
Regarding claim 2, Kamen in view of Pippin in further view of Liu teaches the medical fluid pump according to claim 1, as described above, further comprising a U-shaped bracket (Kamen: Fig. 40: bracket 631 with connected U-shaped center rib 633, see annotated Fig. 40 above) extending in an axial direction of the drive arm (Kamen: Fig. 40: 631 extends along the 524 axis), the U-shaped bracket being integrally formed on a side of the drive head lower shell facing the interior space (Kamen: Fig. 40, 631 and 633 integrally formed on interior side of 602) so that the U-shaped bracket encompasses the drive arm and delimits an axial insertion depth of the drive arm in the drive head lower shell (Kamen: Fig. 40: bracket 631 and associated U-rib 633 encompass and connect to 524, delimiting its insertion depth withing 522; col. 58, lines 15-24).
Regarding claim 3, Kamen in view of Pippin in further view of Liu teaches the medical fluid pump according to claim 2, as described above, wherein the metallic support structure comprises a first portion (Kamen: upper and lower projections 633, and plate 649, see annotated Fig. 40 above) and a second portion formed separately from the first portion (Kamen: 651 and projection “A” from 600 seen in annotated Fig. 38 above), each of the first portion and the second portion abutting on the drive arm (Kamen: upper and lower projections 633 abut arm 524, col. 58, lines 22-24; and projection “A” of the second portion abuts arm 524 at position seen in annotated Fig. 44 below).
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Annotated Fig. 44, Kamen
Regarding claim 4, Kamen in view of Pippin in further view of Liu teaches the medical fluid pump according to claim 3, as described above, wherein the first portion and the second portion form a clamp which clamps the drive arm at the U-shaped bracket so that the drive arm is fixed in an axial direction and fixed against rotation (Kamen: Fig. 44: 649 of the first portion forms clamp with 651 of the second portion, 651 being fixed to the upper shell 600, col. 54, lines 8-16, such that clamping of 649 and 651 secures arm 524 between projection “A” and the 631 + 633).
Regarding claim 5, Kamen in view of Pippin in further view of Liu teaches the medical fluid pump according to claim 4, as described above, wherein the clamp has an inner contour reproducing the U-shaped bracket (Kamen: upper and lower 633 projections of the first portion reproduce the contour of the center 633 projection of the bracket, col. 58, lines 23-24) which permits an axial and rotational fine alignment at the U-shaped bracket (permitting rotation of 524 against 633 when screws 630 are not engaged).
Regarding claim 6, Kamen in view of Pippin in further view of Liu teaches the medical fluid pump according to claim 3, as described above, wherein the first portion is indirectly connected to the drive head lower shell via a screwed connection (col. 58, lines 1-4).
Regarding claim 7, Kamen in view of Pippin in further view of Liu teaches the medical fluid pump according to claim 3, as described above, wherein the first portion includes a recess for passing through cables (Kamen: Fig. 40: recess of 649; col. 57, lines 66 – col. 58, lines 11). Although Kamen discloses that this recess is for passing through the dial shaft and not cables, the recitation of this limitation is an intended use limitation, and as such is given no patentable weight, as the disclosed recess/passage would be capable of passing through cables the same as passing through the dial shaft.
Regarding claim 8, Kamen in view of Pippin in further view of Liu teaches the medical fluid pump according to claim 3, as described above, wherein the first portion and the second portion are detachable from each other (Kamen: annotated Figs. 40 and 38 above show the first and second portions of the metallic support structure detached from each other when the upper and lower shells of the drive head are separated).
Regarding claim 9, Kamen in view of Pippin in further view of Liu teaches the medical fluid pump according to claim 1, as described above, wherein the metallic support structure engages in bores of the drive arm and fixes the drive head lower shell relative to the drive arm in an axial direction and fixes the drive head lower shell against rotation (Kamen: Fig. 40: two bores in 524 where screws 630 engage, preventing movement and rotation). However, Kamen does not explicitly disclose the drive arm being fixed to the drive head lower shell via projections from the lower shell engaged in the drive arm bores, and instead teaches screws 630 creating this engagement.
Kamen does teach, on another portion of the device, engagements via projecting pins engaging in bores to connect two parts (part 940 in Fig. 55 connects to base 902 in Fig. 54 via projection 904 of base 902 which engages in bore (942) of 940. Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the screw (630) attachment of arm 524 to the lower shell 602 by incorporating the projection pin teaching of 904 into the lower shell structure where the screws 630 attach, such that the projections fit through the bores of the arm seen in Fig. 40, in order to reduce the number of additional parts, and eliminate possible rotation around the bores, as is achieved by 904 in 942 (col. 71, lines 25-29).
Regarding claim 11, Kamen in view of Pippin in further view of Liu teaches the medical fluid pump according to claim 1, as described above, wherein the medical fluid pump is a syringe pump (Kamen: Fig. 28, col. 31, lines 50-52).
Response to Arguments
Applicant's arguments filed 10/23/2025 regarding the prior art rejections of claims 1-11 have been fully considered but they are not persuasive.
On page 5 of the Remarks, Applicant asserts that the claimed base plate is “merely inserted or attached by not screwed with the drive head lower shell,” however, these features are not specifically claimed. The amended inclusion of the base plate in independent claim 1 has been rejected with Kamen, as described above and noted in the annotated Fig. 44 above. The amended inclusion of the electrical components has also been rejected with Kamen, as described above and noted in the annotated Fig. 44 above. Applicant asserts that these amended features are not disclosed by Kamen, however, Examiner maintains the above reference to the Kamen components which read on these added limitations.
Applicant argues that the newly amended limitation of “the drive head upper shell closes and fluid-tightly seals the interior space without aligning the base plate in the drive head lower shell” is not disclosed by Kamen or taught by the combination of Kamen in view of Pippin. However, as noted in the 112(b) rejection above, this limitation is indefinite, as the meaning of the alignment and the components involved in that alignment are not defined. Furthermore, Examiner argues that some alignment of the base plate with the other components must occur by nature of the connecting and sealing of the upper and lower shells if the base plate is located in the interior space between them. Examiner maintains that Kamen in view of Pippin teaches this limitation as it is best understood and interpreted by the Examiner (see above).
For these reasons, independent claim 1 and its depending claims 2-9 and 11 stand rejected as recited above.
Conclusion
THIS ACTION IS MADE FINAL. 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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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783