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 .
Election/Restrictions
Claims 154-160 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/07/2026.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 12/04/2024 has/have been considered by the Examiner.
Status of the Claims
Claims 137-160 are currently pending. Claims 137-153 are currently rejected. Claims 154-160 are currently withdrawn.
Claim Objections
Claims 144 and 152 are objected to because of the following informalities:
Claim 144 line 2 reads “a plurality of ducts which that converge”. This should read either “a plurality of ducts .
Appropriate correction is required.
A series of singular dependent claims is permissible in which a dependent claim refers to a preceding claim which, in turn, refers to another preceding claim.
A claim which depends from a dependent claim should not be separated by any claim which does not also depend from said dependent claim. It should be kept in mind that a dependent claim may refer to any preceding independent claim. In general, applicant's sequence will not be changed. See MPEP § 608.01(n).
Examiner notes for the record that claims 144 and 152, which depend from claim 138 as currently written, should not have been separated from claim 138 by intervening claims 139-143 and claims 145-151.
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 137-153 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 137 recites the limitation “the preform shape” on lines 5-6. There is insufficient antecedent basis for this limitation in the claim. However, line 5 of claim 137 does introduce “a preformed shape”. It is unclear whether “the preform shape” is meant to refer back to “a preformed shape” (in which case “the preform shape” should be changed to “the preformed shape”) or “the preform shape” is meant to introduce a different structure (in which case the claim terminology should be altered to better define the second structure, and “a” should be used to introduce the structure). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 137 recites the limitation “the surface of reservoir recess” on line 6 and “the surface of the reservoir recess” on line 8. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether “the surface” is meant to refer back to “the attachment surface” or introduce a new surface associated with the reservoir recess. Furthermore, since “reservoir recess” on line 6 is not preceded by an article, it is unclear whether “reservoir recess” is meant to refer back to “a reservoir recess” introduced on line 2 or introduce a different recess. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 137 recites the limitation “an empty state” on line 10. Claim 137 earlier introduced the limitation “an empty state” on line 7. It is unclear whether the second instance of this limitation is meant to introduce a new structure/state (in which case the naming convention should be altered to distinguish the structures) or refer back to the same structure/state earlier introduced (in which case the article should be changed to “the”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 147 recites the limitation “a portion of the perimeter” on lines 1-2. Claim 146, from which claim 147 depends, earlier introduces the limitation “a portion of a perimeter”. It is unclear whether the second instance of this limitation is meant to introduce a new structure/state (in which case the naming convention should be altered to distinguish the structures) or refer back to the same structure/state earlier introduced (in which case the article should be changed to “the”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 149 recites the limitation “the first portion”. There is insufficient antecedent basis for this limitation in the claim. Claim 148, from which claim 149 depends, earlier introduces “a portion” and “a second portion”. It is unclear whether “a portion” is meant to introduce a new structure/state (in which case the naming convention should be altered to distinguish the structures) or refer back to “a portion” earlier introduced (in which case the naming convention should be altered to match, preferably changing “a portion” in claim 148 to “a first portion”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 150 recites the limitation “the width” in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation has been interpreted to read “a width”.
Claim 151 recites the limitation “the first portion” on line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 148, from which claim 149 depends, earlier introduces “a portion” and “a second portion”. It is unclear whether “a portion” is meant to introduce a new structure/state (in which case the naming convention should be altered to distinguish the structures) or refer back to “a portion” earlier introduced (in which case the naming convention should be altered to match, preferably changing “a portion” in claim 148 to “a first portion”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 151 recites the limitation “the second width” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether claim 152 is meant to depend from claim 150, which does introduce “a second width” (in which case claim 151 should be written as dependent on claim 150 instead of claim 148), or separately introduce a “second width” (in which case the article in claim 151 should be changed from “the” to “a”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 138-153 are rejected for being dependent upon a claim rejected under 112b, since dependent claims inherit the deficiencies of the claims on which they depend.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 137, 140, and 145 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Barnes et al (US-20200023119-A1; hereafter Barnes).
Regarding claim 137, Barnes discloses a cassette (reservoir 200, fig. 2, [0023]) for a drug delivery device comprising:
a cassette base portion (semi-rigid shell component 202, fig. 2, [0023]) including a reservoir recess (see fig. 2) surrounded by an attachment surface (perimeter of semi-rigid shell component 202 noted in [0023]), the attachment surface including a reservoir outlet flow path (side port 206, fig. 2, [0024]) recessed therein (see fig. 2 which shows that the outlet flow path/side port 206 is formed in the attachment surface as noted in [0023]); and
a reservoir film (flexible component 204) coupled to the attachment surface ([0023] the flexible component 204 may be sealed (i.e., coupled to form hermetic seal) to the shell component 202—for example, along a perimeter of the shell component 202) and, together with the reservoir recess, defining a flexible reservoir (chamber 208, fig. 2, [0023] flexible component 204 may provide a chamber 208 for storing a fluid; see fig. 2 which shows chamber formed between reservoir recess of shell component 202 and flexible component 204), a portion of the reservoir film having a preformed shape which mimics the contour of the reservoir recess, the preform shape (see 112b interpretation above) causing the reservoir film to be disposed adjacent the surface of reservoir recess (see 112b interpretation above) when the reservoir is in an empty state (see deflated state 204-1 in side view of fig. 2 which shows that when the flexible film 204 is deflated it is disposed adjacent the surface of the reservoir recess, matching the shape of reservoir 208; [0023]); and
at least one duct (one or more recessed drainage channels 210, fig. 2, [0025]) recessed into the surface (see 112b interpretation above) of the reservoir recess (see side view in fig. 2, [0025] “The drainage channels 210 may be formed into the shell component 202, for example, into an inner surface of the shell component 202”), each of the at least one duct defining a flow path which remains in fluid communication with the reservoir outlet flow path when the reservoir is in an empty state (see 112b interpretation above) (see side view in fig. 2 which shows that the flow path of the drainage channels 210 is still in communication with the port 206).
Regarding claim 140, Barnes discloses the cassette of claim 137, as described above. Barnes further discloses wherein the reservoir film (204, fig. 2) is heat bonded to the attachment surface(perimeter of semi-rigid shell component 202 noted in [0023]) ([0033] describes how reservoir film 204 may be sealed to the shell component 202 by flame bonding, hot air gun, hot knife welding, and/or hot plate welding).
Regarding claim 145, Barnes discloses the cassette of claim 137, as described above. Barnes further discloses wherein the at least one duct (210, fig. 2) includes a first duct and a second duct which furcates off of the first duct (see Modified Fig. 2 Detail below).
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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.
Claim(s) 138, 144, and 152 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barnes as applied to claim 137 above, and further in view of Kirkpatrick (US-20120022494-A1; hereafter Kirkpatrick).
Regarding claim 138, Barnes discloses the cassette of claim 137, as described above.
Barnes is silent to wherein the reservoir film comprises an outcrop region that is included in the reservoir film and forms a seal over the reservoir outlet flow path when the reservoir film is coupled to the attachment surface.
Kirkpatrick, in the field of infusion pumps, teaches wherein the reservoir film (sheet of material noted in [0023] “The entire surface of body 50 may be covered with a sheet of material (not shown) that provides at least flexible portions over pumping chamber 12 as well as sealing the channels 52 to form fluid conduits”; see fig. 2D) comprises an outcrop region (portions of sheet of material sealing the channels 52, noted in [0023], see channels 52 in fig. 2D) that is included in the reservoir film and forms a seal over the reservoir outlet flow path (channel 52, fig. 2D, [0023]) when the reservoir film is coupled to the attachment surface (see [0023], body 50 and circumferential wall 48 in fig. 2D).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the reservoir outlet flow path and the reservoir film of Barnes such that an outcrop region of the reservoir film seals over the reservoir outlet flow path as taught by Krikpatrick, since both references deal with pumping chambers with flexible membranes. One would have been motivated to make the modification because having the flexible reservoir film seal over the flow path as well as the pump chamber would allow someone assembling the device to clearly see that the flow path as well as the pump chamber was clear of debris during assembly, and furthermore may facilitate easier cleaning of the apparatus at a later juncture since the outlet flow path may be exposed and more easily accessed for cleaning when partially formed by the covering flexible reservoir film.
Regarding claim 144, Barnes modified by Kirkpatrick discloses the cassette of claim 138, as described above. Barnes further discloses wherein the at least one duct includes a plurality of ducts which that converge together at a confluence, the confluence disposed intermediate the reservoir outlet flow path and the ducts (see Modified Fig. 2 Detail 2 below).
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Regarding claim 152, Barnes modified by Kirkpatrick discloses the cassette of claim 138, as described above. Barnes further discloses wherein the at least one duct (210, fig. 2) includes a plurality of ducts which extend from a confluence region at regular angular intervals, the confluence region being disposed intermediate the plurality of ducts and the reservoir outlet flow path (see Modified Fig. 2 Detail 3 below).
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Claim(s) 139 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barnes.
Regarding claim 139, Barnes discloses the cassette of claim 137, as described above.
Barnes embodiment fig. 2 is silent to wherein the reservoir film includes at least two layers.
Barnes fig. 8, directed to a similar embodiment, teaches wherein the reservoir film includes at least two layers ([0061] a first membrane material 802 and a second membrane material 804 may be laminated together to provide localized stiffness).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the reservoir film 204 of Barnes fig. 2 to include multiple layers, as taught by Barnes fig. 8 and [0061], since Barnes fig. 8 and [0061] also deal with flexible membranes for use with medical reservoirs. One would have been motivated to make the modification because, as noted by [0062], having a second membrane material “may provide localized areas that facilitate easier folding, manufacturing, and consistent collapse of a flexible reservoir, while maintaining desired vapor barrier properties across most of the surface area as a result of the lamination”.
Claim(s) 141-143 and 146-151 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barnes as applied to claim 137 above, and further in view of Karol et al (US-20190316948-A1; hereafter Karol).
Regarding claim 141, Barnes discloses the cassette of claim 137, as described above. Barnes further discloses wherein the cassette base portion (202, fig. 2) includes a side wall (see portion of cassette base portion 202 overlaid with a dotted line in Modified Fig. 2 Detail 5 below) having a fill port (side port 206, fig. 2, [0024]) leading to an interior volume (interior volume of chamber 208 in which fluid is stored, fig. 2, [0024] “When inflated or expanded, the flexible component 204 may provide a chamber 208 for storing a fluid”) of the reservoir ([0024] “A liquid drug or other fluid may enter and/or exit the drug reservoir 200 from the side port 206.”).
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Barnes discloses all the claim limitations except for the fill port being present in addition to a reservoir outlet flow path (side port 206, fig. 2, [0024]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include, in addition to the side port mapped to the reservoir outlet flow path, an additional side port acting as a fill port, since Barnes teaches the side port 206 being used both for inflow and outflow, and it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See MPEP 2144.04 (VI-B). One would have been motivated to make the modification because having dedicated ports for inflow and outflow ensures that residual fluid is flushed from the port and chamber as a directional flow may be established.
Alternatively, Barnes is silent to a fill port being present in addition to a reservoir outlet flow path.
Karol, in the art of infusion pumps with flexible membranes, teaches a fill port (lower opening 187 and lower pump valve ports 190, fig. 6, [0317] describes fluid being drawn into the reservoir/pump chamber 181 through the lower opening 187) being present in addition to a reservoir outlet flow path (upper openings 191 and upper pump valve ports 192, fig. 6, [0318] describes flow of fluid out of the reservoir through upper opening 191).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the reservoir of Barnes to include a fill port in addition to a reservoir outlet flow path as taught by Karol since both references deal with infusion pumps with flexible membranes. One would have been motivated to make the modification because the arrangement of having a separate inlet and outlet allows for a more consistent flow direction which may help to ensure no fluid resides too long in any one part of the system, and further helps to ensure cleanliness of the source fluid since no used fluid is pushed back through the system through the source channel/inlet.
Regarding claim 142, Barnes, or Barnes modified by Karol, discloses the cassette of claim 141, as described above.
Barnes is silent to wherein a basin is recessed into the reservoir recess directly downstream of an inlet leading to the interior volume of the reservoir from the fill port.
Karol further teaches wherein a basin (see basin noted in Karol Modified Fig. 6 Detail and Karol Modified Fig. 4 Detail, both below) is recessed into the reservoir recess (see Modified Fig. 4 Detail)
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directly downstream of an inlet (opening 187, fig. 6, [0137]) leading to the interior volume of the reservoir from the fill port ([0317] describes flow from opening 187 to opening 191, thus fluid flows along the dotted arrow below in Modified Fig. 6 Detail below).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify Barnes to include the basin downstream of the inlet, and the duct connected to the basin, as taught by Karol, since both references deal with pump reservoir recesses having recessed ducts. One would have been motivated to make the modification because the basin of Karol beneficially provides a place for the fluid collected in the ducts to pool between the inlet and the outlet of the reservoir, providing a direct preferential path from the inlet to the reservoir outlet flow path.
Regarding claim 143, Barnes modified by Karol discloses the cassette of claim 142, as described above, including wherein at least one of the at least one duct extends into communication with the basin (see Karol Modified Fig. 4 and 6 Details above).
Regarding claim 146, Barnes discloses the cassette of claim 137, as described above.
Barnes is silent to a duct disposed along a portion of a perimeter of a bottom surface adjacent a wall.
Karol, in the art of reservoir recesses with flexible membranes, teaches wherein the reservoir recess (pump chamber 181, fig. 4, [0317]) includes a wall (see Karol Modified Fig. 4 Detail 2 below) which extends from a bottom surface (see Karol Modified Fig. 4 Detail 2 below) of the reservoir recess to the attachment surface (see Karol Modified Fig. 4 Detail 2 below) and the at least one duct includes a duct (see Karol Modified Fig. 4 Detail 2 below) which is disposed along a portion of a perimeter of the bottom surface adjacent the wall (see fig. 3 which shows that the indicated duct is along the perimeter of the reservoir recess).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the reservoir recess of Barnes to include a duct along the perimeter of the edge of the reservoir recess, as taught by Karol, since both references deal with flexible membranes over reservoirs. One would have been motivated to make the modification because the duct along the outer wall ensures that all fluid, even that at the edges, is not when the flexible membrane begins to press down as fluid is forced out of the reservoir, but instead the duct guides the fluid toward the middle of the reservoir recess which connects to the reservoir outlet flow path. Thus, the perimeter duct of Karol would facilitate better drainage of the pump chamber.
Regarding claim 147, Barnes modified by Karol discloses the cassette of claim 146, as described above, including wherein the duct (see Karol Modified Fig. 4 Detail 2 below) disposed along a portion (see 112b interpretation above) of the perimeter is disposed along a majority of the perimeter (see Karol fig. 3 which shows that the noted duct extends along the majority of the perimeter of the reservoir recess).
Regarding claim 148, Barnes discloses the cassette of claim 137, as described above.
Barnes is silent to a duct recessed into a bottom surface and a wall of a reservoir recess.
Karol, in the art of infusion pumps, teaches wherein the reservoir recess includes a wall (indicated by the dashed line in Modified Fig. 4 Detail 3) which extends from a bottom surface (indicated by the dotted line in Modified Fig. 4 Detail 3) of the reservoir recess (pump chamber 181, fig. 4, [0317]) to the attachment surface (see Modified Fig. 4 Detail 3 below) and the at least one duct includes a portion recessed into the bottom surface and a second portion recessed into the wall (see noted duct portions in Modified Fig. 4 Detail 3 below; see fig. 3 which shows that the first and second duct portions are connected).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify Barnes to include duct portions recessed both into the bottom surface of the reservoir recess and a wall of the reservoir recess, since both references deal with reservoir recesses covered by flexible membranes and having ducts. One would have been motivated to make the modification because the ducts in the bottom surface and wall of Karol ensure fluid from every area of the reservoir recess is directed toward the center of the reservoir recess and improves drainage from every part of the reservoir recess by extending the ducts into the wall.
Regarding claim 149, Barnes modified by Karol discloses the cassette of claim 148, as described above. Barnes further discloses wherein the first portion (see 112b interpretation above) of the at least one duct has a first width (see first width of first portion in Modified Fig. 2 Detail 4 below) and the second portion (see Modified Fig. 2 Detail 4 below) of the at least one duct has a variable width ([0026] the channels…may have a graded depth to facilitate flow toward a port).
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Alternatively, Barnes modified by Karol teaches all limitations except for wherein the second portion of the at least one duct has a variable width. It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to alter the second portion to have a variable width, since this limitation represents only a change in size/proportion (MPEP 2144.04(IV)(A)). It further would have been obvious to make this modification since Barnes [0026] notes that “the channels…may have a graded depth to facilitate flow toward a port”, thus establishing graded dimensions along the ducts. One would have been motivated to make the modification because having variable width along the duct may better facilitate the funneling of fluid toward the reservoir outlet flow path.
Regarding claim 150, Barnes modified by Karol discloses the cassette of claim 148, as described above. Barnes further discloses wherein the width (see 112b interpretation above; width is interpreted to be synonymous with depth as described in Barnes) of the second portion (see Modified Fig. 2 Detail 4 above) of the at least one duct tapers from a first width to a second width smaller than the first width ([0026] the channels…may have a graded depth to facilitate flow toward a port).
Alternatively, Barnes modified by Karol teaches all limitations except for wherein the second portion of the at least one duct tapers from a first width to a smaller width. It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to alter the second portion to have a variable width, since this limitation represents only a change in size/proportion (MPEP 2144.04(IV)(A)). It further would have been obvious to make this modification since Barnes [0026] notes that “the channels…may have a graded depth to facilitate flow toward a port”, thus establishing graded dimensions along the ducts. One would have been motivated to make the modification because having variable width along the duct may better facilitate the funneling of fluid toward the reservoir outlet flow path.
Regarding claim 151, Barnes modified by Karol discloses the cassette of claim 148, as described above. Barnes further discloses wherein the first portion (see 112b interpretation above) of the at least one duct is the second width (see 112b interpretation above) (see Modified Fig. 2 Detail 4, Examiner notes that in claim 151 as written and interpreted under 112b, no particular width/reference/quality is assigned to “the second width”, the “first portion” noted in Modified Fig. 2 Detail 4 above has “a width” as shown which is interpreted to be “the second width”.).
Claim(s) 153 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barnes as applied to claim 137 above, and further in view of Demers et al (US-20090095679-A1; hereafter Demers).
Regarding claim 153, Barnes discloses the cassette of claim 137, as described above.
Barnes is silent to wherein the reservoir outlet flow path includes an air trap.
Demers, in the art of infusion pumps, teaches wherein the reservoir outlet flow path (see flow path from dialyzer 14 through air trap 19, fig. 1, [0004]) includes an air trap (air trap 19, fig. 1, [0004] “the blood may pass through other components, such as a filter and/or an air trap 19, before returning to the patient”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the reservoir outlet flow path of Barnes to include an air trap as taught by Demers since both deal with pumps providing fluid to patients. One would have been motivated to make the modification because including an air trap in the reservoir outlet flow path since this modification would help to prevent embolisms in the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 06/02/2026
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