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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 8, 72-73 and 76 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2014/0134002 to Brettschneider et al. (Brettschneider hereinafter).
Regarding claim 1, Brettschneider teaches a pump (100) suitable for infusion, comprising a plurality of serially connected reservoirs (20, 50, 51, 52), wherein a flow resistance between adjacent reservoirs increases in a downstream direction (from inlet 200 to outlet 300, see Fig. 2 and paragraph 37), wherein an outlet (300) of the pump is fluidly connected to the last downstream reservoir (52). The examiner notes that as a matter of claim interpretation, the flow resistance is not tied to the infused fluid or passages therefor and no limitation is made on the structure or function of the reservoirs. Furthermore, the flow resistance is not substantively tied to the pumped fluid nor is the downstream direction tied to the fluid experiencing the resistance. As such, it is sufficient for anticipation that Brettschneider teaches a downstream direction of pumped fluid and resistance acting on a motive fluid which increases along that direction.
Regarding claim 2, Brettschneider teaches a plurality of channels (30, 60, 61, 62) wherein each reservoir upstream from the last (52) is connected to an adjacent downstream reservoir by at least one channel (60, 61, 62) and wherein the channels are configured to provide increasing flow resistance in the downstream direction.
Regarding claims 3 and 72, Brettschneider teaches a first (50), second (51), and third (52) reservoir, an outlet (downstream end of 300), a first channel (60) and a second channel (61) extending between respective reservoir pairs, and a third channel (62) with resistances increasing toward the outlet.
Regarding claim 4, Brettschneider teaches an outlet channel (300).
Regarding claims 5 and 73, Brettschneider teaches fluids in the reservoirs. The examiner notes that the claim is directed to the infusion pump, rather than to a therapeutic compound or any method of using the pump. As these reservoirs are capable of holding therapeutic compounds and the limitation of what is held in the reservoirs is essentially an intended use, the examiner holds that claim 5 is anticipated by Brettschneider.
Regarding claims 8 and 76, Brettschneider teaches a filling port (200).
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.
Claim(s) 6-7, 9-15 and 74-75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brettschneider in view of US Pre-Grant Publication 2003/0216684 to Fentress et al. (Fentress).
Regarding claims 6-7 and 74-75, Brettschneider teaches the invention of claim 1 from which claim 6 depends, as discussed above. However, in the interpretation advanced with respect to claim 1, Brettschneider does not teach at least one pump operatively coupled to the reservoirs, as the reservoirs are interpreted as including the drive chambers within each well (20, 50, 51, 52). Herein, the examiner advances a different interpretation, in which Brettschneider is understood to teach a plurality of reservoirs (20, 50, 51, 52) for infusing fluids with connecting channels (as illustrated in Fig. 1 between the enumerated reservoirs). Brettschneider is silent as to different resistances in these channels (i.e. channels for the pumped fluid). Fentress teaches another fluid system generally, and teaches that increasing resistance downstream leads to improved mixing (paragraph 45). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide increased resistance in a downstream direction of the pump of Brettschneider as taught by Fentress in order to promote mixing therein. In this combination, the drive fluid side of the wells (20, 50, 51, 52) are considered pumping elements which are operatively coupled to the reservoirs.
Regarding claim 9, Brettschneider teaches a plurality of reservoirs (20, 50, 51, 52) with connecting channels (as illustrated in Fig. 1). Brettschneider is silent as to different resistances in these channels (i.e. channels for the pumped fluid). Fentress teaches another fluid system generally, and teaches that increasing resistance downstream leads to improved mixing (paragraph 45). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide increased resistance in a downstream direction of the pump of Brettschneider as taught by Fentress in order to promote mixing therein. In this combination, the drive fluid side of the wells (20, 50, 51, 52) are considered pumping elements which are operatively coupled to the reservoirs.
Regarding claims 10 and 11, Brettschneider teaches the claimed flow steps (see discussion of Fig. 1).
Regarding claim 12, Brettschneider teaches a filling port (200).
Regarding claims 13-15, Brettschneider as modified in view of Fentress teaches the invention of claim 1 from which these claims depend, but is silent as to particular dimensions. It has been held by the courts that where the difference between the claimed invention and the prior art is solely a limitation of relative dimensions and there is no unexpected result, a prima facie case of obviousness is present (MPEP 2144.04 IV A). In this case, the relative dimensions are the only distinction, and there is no evidence of record to suggest that the claimed dimensions result in any criticality. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use the claimed dimensions as a matter of law.
Response to Arguments
Applicant's arguments filed 10 December 2025 have been fully considered but they are not persuasive.
With respect to the argument that the broadest reasonable interpretation is limited to flow resistance experienced by a therapeutic fluid (Remarks, page 6), the examiner is not persuaded. The cited sections of applicant’s specification merely repeat the language of either claim 1 or claim 9, and do not limit the claimed invention to flow channels through which a therapeutic fluid passes. Indeed, claim 1 does not recite a therapeutic fluid. As such the examiner is not persuaded that the broadest reasonable interpretation is limited as proposed by applicant and is therefore prohibited from importing limitations from the specification into the claims. Notably, the examiner is well aware of the distinctions between applicant’s disclosed invention and Brettschneider’s apparatus. However, in the absence of language further limiting the claimed invention in either the specification or the claims themselves, the case for anticipation remains intact.
With respect to the argument that Brettschneider and Fentress are improperly combined, the examiner is unaware of any requirement that an obviousness rejection maintain the same interpretation as an anticipation reference.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the function of the increase in flow resistance) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In view of the above, the rejections are maintained.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 15 January 2026