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 .
Specification
The amendments to the specification were received on 9/17/25. The amendments are accepted.
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 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.
Claims 1-5, 8-11 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 the limitation "the cam assembly" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claims 4, 5 and 9 also recite “the cam assembly” which now lacks a proper antecedent basis after the amendments to claim 1.
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 4, 5, and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dehan et al. (US 2016/0160854 A1, cited previously and hereafter “Dehan”).
As to claim 1, Dehan discloses a pump (1) for medical fluid (para 0002) comprising:
a pump housing (2);
a manifold (5) within the pump housing (2), and having a manifold chamber (21) therein, an input port (11) and an output port (12);
a cannula (16) received within the manifold chamber (21), and having an input hole (22, 26) and an output hole (23, 27), arranged on opposite sides of the cannula and offset along an axis of the cannula (see Fig. 1, para 0034) to correspond with positions of the respective input port and output port of the manifold (see para 0034-0036);
a cam (15, 20, SI1, SI2) received within a cam chamber (interior of 4), wherein the cam assembly is fixed to the cannula (para 0031), and adapted to cause the cannula to reciprocally translate in an axial direction (T1, T2) as the cam is rotated (see para 0033),
wherein the cannula (16) is a tube (see inner passage (25) of (16)) having a predetermined inner diameter (diameter of 25), and the cannula reciprocates axially a predetermined distance to form a discrete pump volume with the predetermined inner diameter of the tube (para 0033, last seven lines).
Dehan does not expressly recite that the tube is a metal tube. However, modifications regarding materials are generally considered to be modifications that are obvious to and well within the purview of one with ordinary skill in the art. Further, it is known that in the course of ordinary research and discovery a skilled artisan will attempt to design a device by using materials that will allow the device to operate in an optimal manner in its intended environment and/or application (see MPEP 2144.07). Therefore, it would have been obvious to one with ordinary skill in this art at the time of the invention to modify the pump of Dehan by making the cannula from a metal tube, as a matter of preference based on the intended application of the pump, and for the purpose of making the cannula stronger and less susceptible to wear or deformation.
As to claim 4, Dehan makes obvious the pump of claim 1 as described above, and further discloses wherein the cam assembly is arranged to cause the cannula input hole to align with the input port as the manifold chamber is increasing in size (Fig. 3, para 0042).
As to claim 5, Dehan makes obvious the pump of claim 1 as described above, and further discloses wherein the cam assembly is arranged to cause the cannula output hole to align with the output port as the manifold chamber is decreasing in size (Fig. 6, para 0044).
As to claim 9, Dehan makes obvious the pump of claim 1 as described above, and further discloses wherein the cam assembly comprises ramp surfaces (SI1, SI2) that interact to move the cannula axially in a reciprocal manner as the cam rotates (para 0033).
As to claim 10, Dehan makes obvious the pump of claim 1 as described above, and further discloses wherein the input port and the output port are on the same side of the manifold chamber (see Figs. 2-7).
As to claim 11, Dehan makes obvious the pump of claim 1 as described above, and further discloses wherein the input hole and the output hole are arranged such that only one of the input hole and output hole can be aligned with either of the input port or the output at a given time (Figs. 2-7, para 0034).
Claim(s) 2, 3, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dehan in view of Thiemer et al. (WO 2013/046156 A1, cited by applicant on 9/30/22 IDS and hereafter “Thiemer”).
Regarding claim 2, Dehan discloses the pump of claim 1, but fails to specifically disclose that [Cl. 2] the cam chamber is formed from a cam chamber housing having a cam surface, and a cam chamber cap having a cam surface. However, Thiemer discloses a similar pump ((4); figs. 1A, 1B, 2) that comprises, inter alia, a cam assembly (25, 66, 12) located within a cam chamber (14), the cam chamber (14) formed from a cam chamber housing (34) having a cam surface (30b) and a cam chamber cap (37) having a cam surface (30a). A cam assembly (25, 66, 12) is received within a cam chamber (14), wherein the cam assembly (25, 66, 12) is fixed to a cannula (42), and adapted to cause the cannula (42) to reciprocally translate (A1, A2) in the axial direction as the cam (25, 66, 12) is rotated (p.16, lines 23-26). Therefore, it would have been obvious to one with ordinary skill in this art before the effective filing date of the claimed invention to modify the pump of Dehan by replacing the cam assembly and cam chamber with cam chamber that is formed from a cam chamber housing having a cam surface, and a cam chamber cap having a cam surface, as taught by Thiemer, for the purpose of fully enclosing the cam assembly within the cam chamber to thereby prevent debris from fouling the cam assembly.
Regarding claims 3 and 8, the modified Dehan discloses the pump of claim 2. Dehan fails to disclose that [Cl. 3] the cam chamber cap comprises an axial opening, and the cam assembly comprises a motor coupling that extends through the cam chamber cap opening; and
that [Cl. 8] the motor coupling is slidably received within a motor portion. However, Thiemer further discloses (fig. 2), a cam chamber cap (37) that comprises an axial opening (unreferenced; fig. 2), and that the cam assembly (25, 66, 12) comprises a motor coupling (66) that extends through the cam chamber cap opening (fig. 2), and wherein the motor coupling (66) may be slidably received (inherent) within a motor portion (p.12, lines 19-22). Therefore, it would have been obvious to one with ordinary skill in this art before the effective filing date of the claimed invention to further modify the pump of Dehan by making the cam chamber cap with an axial opening so that a motor coupling of the cam assembly extends through cap opening and is slidably received within a motor portion, a taught by Thiemer, for the purpose of keeping the motor attachment outside the cam housing, thereby making replacement of the pump easier to accomplish.
Allowable Subject Matter
Claims 6 and 7 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
As to claims 6 and 7, the applicant has rewritten each claim into independent form. It was noted in the previous office action that Dehan and Thiemer are silent to wherein the cam chamber housing cam surface comprises a ramp shape in combination with the limitations of previous claims 1-2 (claim 6) and wherein the cam chamber cap cam surface comprises a ramp shape in combination with the limitations of previous claims 1-2 (claim 7).
Response to Arguments
Applicant’s Remarks submitted 9/17/25 have been considered.
With regard to the Remarks under the “Specification” heading, the Remarks are persuasive and the previous specification objections have been withdrawn.
With regard to the Remarks under the “Rejections under 35 USC 112” heading, the arguments are persuasive except for the fact that the applicant left an instance of “the cam assembly” in line 8, creating an antecedent basis issue noted above.
With regard to the arguments under the “Rejections under 35 USC 102”, the arguments are not persuasive. Firstly, the examiner notes that the only limitation of instant claim 1 that Dehan is silent to is that the tube is a metal tube. As noted in both the previous and current rejections, modifications regarding materials are generally considered to be modifications that are obvious to and well within the purview of one with ordinary skill in the art (see MPEP 2144.07). The applicant has admitted in their arguments that “Metal tubes are known in needle forming to have very precise inner diameter dimensions. Accordingly, forming the cannula from a metal tube advantageously provides higher accuracy in the pump volume“. Therefore, it can be said that metal is a known type of material and one having ordinary skill in the art would have found it obvious to use metal for the tube. The applicant also states that “In Dehan, the pump volume is made not with the "tube" (identified as structure 25 by the Examiner)”. This is inaccurate. It can be seen from the previous and current rejections that the cannula/tube was interpreted as “16” of Dehan. The part of the rejection that applicant is citing was mentioned to point out how cylindrical portion 16 of Dehan has an inner passage 25 and therefore can be interpreted as a tube. Further, the wording of “the cannula reciprocates axially a predetermined distance to form a discrete pump volume with the predetermined inner diameter of the metal tube” in the context of interpreting claim 1 can be fulfilled simply because of the structure of the cylindrical portion of claim 16. The examiner points out that claim 1 is an apparatus claim and not a method claim. The manner in which Dehan operates does not disqualify it from satisfying the instant claim 1 language. Since the cylindrical portion 16 of Dehan has an inner passage 25, that inner passage can simply be interpreted to form a discrete pump volume in a manner that reads on claim 1. The examiner recommends expanding on how the discrete pump volume is configured to be used and/or how the fluid moves through the cannula.
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 James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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/James D Ponton/Primary Examiner, Art Unit 3783