DETAILED ACTION
Response to Appeal Brief
In view of the appeal brief filed on 05/20/2026, PROSECUTION IS HEREBY REOPENED. A new ground of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
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Examiner’s Note
Prosecution in this application is hereby reopened following the evaluation of the applicant’s appeal brief, wherein the arguments regarding the specific taper orientation relative to the plug were found persuasive with respect to the previous combination. In response to amendments made after the first non-final action, the scope of independent claim 1 changed significantly (specifically reciting that the conical taper of the sleeve and housing tapers “toward the plug”). Because this amended scope distinguishes over fig. 1 of Spreng, the current rejection relies upon a different embodiment – specifically fig. 4 of Spreng – which discloses a tapered cylinder and sleeve construction and mounting configuration that properly addresses the amended claim limitations. Furthermore, this action is designated as Final because the prosecution is being reopened after an appeal brief under circumstances where the new ground of rejection (incorporating fig. 4 of Spreng) is necessitated by the applicant’s amended claim scope in claims filed after Non-Final action, dated 04/07/2025.
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.
Claims 1, 4, 5, 7, 8, 11, 12, 14, 16, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Focht et al. (US 2017/0184091 – herein after Focht) in view of W. M. Spreng et al. (US 2,246,392 – herein after Spreng).
In reference to claim 1, Focht teaches a positive displacement pump comprising (see fig. 14):
a housing (1312);
a sleeve (1308) disposed radially within the housing, wherein an outer shape of a first end of the sleeve (in view of fig. 14: outer circumferential shape of a left end of the sleeve 1308) contacts an inner shape of a first end of the housing (in view of fig. 14: inner circumferential shape of a left end of the housing 1312), wherein the inner shape of the first end of the housing corresponds to the outer shape of the first end of the sleeve, thereby sealing the first end of the sleeve to the first end of the housing (in view of disclosure in ¶122 and figs. 18C-18D); and
a piston (1306), disposed radially within the sleeve, wherein an axially-reciprocating motion of the piston (see ¶120) within the sleeve opens and closes a pump chamber (pump chamber being present in view of disclosure in ¶121 and figs. 17B-17C) defined between a first end of the piston (in view of fig. 14: left end of the piston 1306) and a plug (1316) disposed within the first end (left end in view of fig. 14 or right end in view of fig. 17A) of the sleeve (1308).
Focht remains silent on the pump, wherein the outer shape of the first end of the sleeve is conical tapering toward the plug, and the inner shape of the first end of the housing is conical tapering toward the plug.
However, Spreng teaches a positive displacement pump (see embodiment in fig. 4), wherein the outer shape of the first end (57) of the sleeve (cylinder liner 55) is conical tapering toward the plug {see fig. A below: “conical tapering toward the plug” (i.e. portion that is becoming progressively smaller toward the plug) is shown by directional dotted arrow} and the inner shape of the first end (portion/section 61) of the housing (58) is conical tapering toward the plug {see fig. A below: “conical tapering toward the plug” (i.e. portion that is becoming progressively smaller toward the plug) is shown by directional dotted arrow} [see page 2 of specification, left col., lines 70-73: “The cylinder housing 58 comprises internally tapered end sections 60 and 61 which are adapted to form a fluid tight seal with the cylinder liner parts 56 and 57 respectively”].
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Fig. A: Edited fig. 4 of Spreng to show claim interpretation.
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify the housing and liner in Focht’s pump for conical tapering end portions as taught by Spreng for the purpose of achieving a close fit between the two components, as recognized by Spreng (see page 1 of specification, left col., lines 36-44).
In reference to claim 4, Focht teaches the positive displacement pump, further comprising:
a piston seal (1340, see fig. 16A) disposed at the first end of the piston, and
a plug seal (1348, see fig. 14A or ¶121) disposed at an end of the plug (right of the plug 1316 in view of fig. 14 or left end in view of fig. 17A), wherein the piston seal and the plug seal define the pump chamber therebetween (as evident from disclosure in ¶121 and figs. 17B-17C).
In reference to claim 5, Focht teaches the positive displacement pump, further comprising (see ¶120 and figs. 14,16A, 16B-16D, 17B-17C): a helical slot (1342) formed in the sleeve; and a pin (1310) extending radially outward from the piston (1306), wherein the pin is moveable within the slot (as evident from figs. 16B-16D and 17B-17C), thereby controlling a movement of the piston in radial and axial directions (as discussed in ¶120).
In reference to claim 7, Focht teaches the positive displacement pump, further comprising (see fig. 19 and ¶122) an inlet port (reservoir port 1354) and an outlet port (cannula port 1356) formed through the housing (1312).
In reference to claim 8, Focht teaches a fluid delivery system comprising (140, see fig. 1):
a reservoir (134);
a cannula (129); and
a pump (see fig. 14), the pump comprising:
a housing (1312) having (see fig. 19 and ¶122) an inlet port (reservoir port 1354) and an outlet port (cannula port 1356) formed therethrough, wherein (as evident from disclosure in ¶122 and fig. 1) the inlet port is in fluid communication with the reservoir and the outlet port is in fluid communication with the cannula;
a sleeve (1308) disposed radially within the housing, wherein an outer shape of a first end of the sleeve (in view of fig. 14: outer circumferential shape of a left end of the sleeve 1308) contacts an inner shape of a first end of the housing (in view of fig. 14: inner circumferential shape of a left end of the housing 1312), wherein the inner shape of the first end of the housing corresponds to the outer shape of the first end of the sleeve, thereby sealing the first end of the sleeve to the first end of the housing (in view of disclosure in ¶122 and figs. 18C-18D);
a piston (1306), disposed radially within the sleeve, wherein an axially-reciprocating motion of the piston (see ¶120) within the sleeve opens and closes a pump chamber (pump chamber being present in view of disclosure in ¶121 and figs. 17B-17C) defined between a first end of the piston (in view of fig. 14: left end of the piston 1306) and a plug (1316) disposed within the first end (left end in view of fig. 14 or right end in view of fig. 17A) of the sleeve (1308); and
wherein the sleeve (1308) is moveable between an inlet position (“first position”), in which the pump chamber is in communication with the inlet port (1354), and an outlet position (“second position”), in which the pump chamber is in communication with the outlet port (1356) [see ¶122: “Sleeve 1308 rotates between a first position in which side hole 1358 is aligned with the reservoir port 1354 and a second position in which the side hole 1358 is aligned with the cannula port 1356”].
Focht remains silent on the pump, wherein the outer shape of the first end of the sleeve is conical tapering toward the plug, and the inner shape of the first end of the housing is conical tapering toward the plug.
However, Spreng teaches a positive displacement pump (see embodiment in fig. 4), wherein the outer shape of the first end (57) of the sleeve (cylinder liner 55) is conical tapering toward the plug {see fig. A above: “conical tapering toward the plug” (i.e. portion that is becoming progressively smaller toward the plug) is shown by directional dotted arrow} and the inner shape of the first end (portion/section 61) of the housing (58) is conical tapering toward the plug {see fig. A above: “conical tapering toward the plug” (i.e. portion that is becoming progressively smaller toward the plug) is shown by directional dotted arrow} [see page 2 of specification, left col., lines 70-73: “The cylinder housing 58 comprises internally tapered end sections 60 and 61 which are adapted to form a fluid tight seal with the cylinder liner parts 56 and 57 respectively”].
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify the housing and liner in Focht’s pump for conical tapering end portions as taught by Spreng for the purpose of achieving a close fit between the two components, as recognized by Spreng (see page 1 of specification, left col., lines 36-44).
In reference to claim 11, Focht teaches the fluid delivery system, further comprising:
a piston seal (1340, see fig. 16A) disposed at the first end of the piston, and
a plug seal (1348, see fig. 14A or ¶121) disposed at an end of the plug (right of the plug 1316 in view of fig. 14 or left end in view of fig. 17A), wherein the piston seal and the plug seal define the pump chamber therebetween (as evident from disclosure in ¶121 and figs. 17B-17C).
In reference to claim 12, Focht teaches the fluid delivery system, further comprising (see ¶120 and figs. 14,16A, 16B-16D, 17B-17C):
a helical slot (1342) formed in the sleeve; and
a pin (1310) extending radially outward from the piston (1306), wherein the pin is moveable within the slot (as evident from figs. 16B-16D and 17B-17C), thereby controlling a movement of the piston in radial and axial directions (as discussed in ¶120).
In reference to claim 14, Focht teaches a positive displacement pump comprising (see fig. 14):
a housing (1312);
a sleeve (1308) disposed radially within the housing, wherein an outer shape of the sleeve (in view of fig. 14: outer circumferential shape of the sleeve 1308) contacts an inner shape of the housing (in view of fig. 14: inner circumferential shape of the housing 1312), thereby sealing the sleeve within the housing (in view of disclosure in ¶122 and figs. 18C-18D); and
a piston (1306), disposed radially within the sleeve, wherein an axially-reciprocating motion of the piston (see ¶120) within the sleeve opens and closes a pump chamber (pump chamber being present in view of disclosure in ¶121 and figs. 17B-17C) defined between a first end of the piston (in view of fig. 14: left end of the piston 1306) and a first end (left end in view of fig. 14 or right end in view of fig. 17A) of the sleeve (1308).
Focht remains silent on the pump, wherein the outer shape of the first end of the sleeve is conical tapering toward the plug, and the inner shape of the first end of the housing is conical tapering toward the plug.
However, Spreng teaches a positive displacement pump (see embodiment in fig. 4), wherein the outer shape of the first end (57) of the sleeve (cylinder liner 55) is conical tapering toward the plug {see fig. A above: “conical tapering toward the plug” (i.e. portion that is becoming progressively smaller toward the plug) is shown by directional dotted arrow} and the inner shape of the first end (portion/section 61) of the housing (58) is conical tapering toward the plug {see fig. A above: “conical tapering toward the plug” (i.e. portion that is becoming progressively smaller toward the plug) is shown by directional dotted arrow} [see page 2 of specification, left col., lines 70-73: “The cylinder housing 58 comprises internally tapered end sections 60 and 61 which are adapted to form a fluid tight seal with the cylinder liner parts 56 and 57 respectively”].
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify the housing and liner in Focht’s pump for conical tapering end portions as taught by Spreng for the purpose of achieving a close fit between the two components, as recognized by Spreng (see page 1 of specification, left col., lines 36-44).
In reference to claim 16, Focht teaches the positive displacement pump, further comprising (see ¶120 and figs. 14,16A, 16B-16D, 17B-17C):
a helical slot (1342) formed in the sleeve; and
a pin (1310) extending radially outward from the piston (1306), wherein the pin is moveable within the slot (as evident from figs. 16B-16D and 17B-17C), thereby controlling a movement of the piston in radial and axial directions (as discussed in ¶120).
In reference to claim 17, Focht teaches the positive displacement pump, wherein the sleeve (1308) is rotationally moveable within the housing [see ¶122: “Sleeve 1308 rotates between a first position in which side hole 1358 is aligned with the reservoir port 1354 and a second position in which the side hole 1358 is aligned with the cannula port 1356”].
In reference to claim 19, Focht teaches the positive displacement pump, further comprising (see fig. 19 and ¶122) an inlet port (reservoir port 1354) and an outlet port (cannula port 1356) formed through the housing (1312).
Claims 3 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Focht in view of Spreng and Hofer et al. (US 4,717,317 – herein after Hofer).
Focht teaches the pump, comprising a second end of the housing (in view of fig. 14: right end of the housing 1312).
Focht does not provide any details regarding closing the second end of the housing. Thus, Focht remains silent on the pump with claimed features of a cap and a spring.
However, Hofer teaches a positive displacement pump, comprising: a cap (plate 4) closing a second end of the housing (left end of the housing 3 in view of fig. 1); and a spring (16), disposed between the cap (4) and a second end of the sleeve (left end of the sleeve 2 in view of fig. 1), wherein a pressure of the spring between the cap and the housing biases the sleeve toward the first end of the housing (right end of the housing 3 in view of fig. 1) [see col 2, lines 54-58: “An annular cup spring 16 is provided on the opposite end of the sleeve 2, that is, between the end face 15 of the sleeve 2 and the adjacent plate 4. This spring 16 presses the sleeve 2 in sealing relation onto the end wall of the casing 3”; thus, the spring 16 (in fig. 1) biases sleeve 2 to the right towards the right end of casing 3].
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify the second end of the housing in Focht’s pump for providing a cap and a spring as taught by Hofer for the purpose of closing the second end of the housing in a manner that also secures the sleeve within the housing in a sealing manner, as recognized by Hofer (see col. 2, lines 54-58).
Claims 6, 13 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Focht in view of Spreng, Atwater et al. (US 5,482,448 – herein after Atwater) and evidenced by Gerlach et al. (US 5,096,394 – herein after Gerlach).
Focht remains silent on the pump, wherein the housing and the sleeve are made of polypropylene.
However, Atwater teaches that (see col. 8, lines 31-33) “Engineering plastics as well as high quality steels or other metals may be used to form the components” in a similar positive displacement pump. Gerlach further evidences (see col. 4, lines 30-52) “polypropylene” as a known plastic that can be utilized to manufacture component(s) (such as housing 12) in a similar positive displacement pump.
The claimed housing and sleeve are components of the pump. Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to make the housing and sleeve from engineering plastic, as taught by Atwater, such as polypropylene, as evidenced by Gerlach, in Focht’s pump since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Please note that in the instant application, applicant has not disclosed any criticality for the claimed limitation of making components from specific claimed material, indicating simply (see ¶17 of pg. pub of the instant application) “The housing and the sleeve may be made of polypropylene” and (see ¶47 of pg. pub of the instant application) “According to this example embodiment, the components of the sleeve 220 and the housing 210 are formed of hard plastic and are held together by pressure sufficient to hold during rotation and after sterilization and aging. The hard plastic may be Vespel or polypropylene, as would be understood by one of skill in the art”.
Response to Arguments
Applicant's arguments, Spreng in fig. 1 does not teach the claimed feature “the outer shape of the first end of the sleeve is conical tapering toward the plug, and the inner shape of the first end of the housing is conical tapering toward the plug”, in Appeal Brief filed May 20, 2026 have been fully considered and were found to be persuasive. However, upon further consideration of Spreng, Spreng teaches this claimed feature in another embodiment of the pump shown in fig. 4. As a result, new ground(s) of rejection is made in this Office Action over Spreng’s fig. 4.
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.
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/CHIRAG JARIWALA/Examiner, Art Unit 3746
/MARK A LAURENZI/Supervisory Patent Examiner, Art Unit 3746 8/5/2026
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