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 abstract of the disclosure is objected to because:
In line 1, “device includes” should be changed to “device, the testing system includes”
In line 1, “first and second ends” should be changed to “a first end and a second end”
Line 2 recites “a surrogate syringe barrel”. Line 1 previously recites “a drug delivery device”. It is unclear whether “a surrogate syringe barrel” is part of “a drug delivery device” or not
Line 2 recites “a flange extender”. Line 1 previously recites “a drug delivery device”. It is unclear whether “a flange extender” is part of “a drug delivery device” or not
Line 3 recites “a plunger rod”. Line 1 previously recites “a drug delivery device”. It is unclear whether “a plunger rod” is part of “a drug delivery device” or not
In line 4, “therein” should be changed to “in the surrogate syringe barrel”
In lines 5-6, “first and second ends” should be changed to “a first end and a second end”
In line 6, “therebetween” should be changed to “between the first end and the second end of the plunger rod”
In line 6, “the first end” should be changed to “the first end of the plunger rod”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1-2, 5-6, 8, and 13-19 are objected to because of the following informalities:
In regards to claim 1, line 1, “device comprising:” should be changed to “device, the testing system, comprising:”.
In regards to claim 1, line 6, “with the of the frame member” should be changed to “with the frame member”.
In regards to claim 1, line 9, “therein” should be changed to “in the surrogate syringe barrel”.
In regards to claim 1, line 10, “therebetween” should be changed to “between the first end and the second end of the plunger rod”.
In regards to claim 1, line 10, “the first end” should be changed to “the first end of the plunger rod”.
In regards to claim 2, line 2, “thereof” should be changed to “of the plunger rod”.
In regards to claim 5, line 2, “the plunger rod” should be changed to “the plunger rod interface”.
In regards to claim 6, line 2, “the flange” should be changed to “the flange extender”.
In regards to claim 8, line 2, “thereof” should be changed to “of the frame member”.
In regards to claim 8, line 3, “thereof” should be changed to “of the frame member”.
In regards to claim 13, line 10, “therebetween” should be changed to “between the first end and the second end of the plunger rod”.
In regards to claim 14, line 2, “thereof” should be changed to “of the plunger rod”.
In regards to claim 15, line 2, “the step” should be changed to “a step”.
In regards to claim 16, line 2, “the step” should be changed to “a step”.
In regards to claim 16, line 3, “thereof” should be changed to “of the frame member”.
In regards to claim 17, line 1, “the step of moving” should be changed to “the moving”.
In regards to claim 18, lines 1-2, “the step of moving” should be changed to “the moving”.
In regards to claim 19, line 1, “the step” should be changed to “a step”.
Appropriate correction is required.
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 1-19 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.
In regards to claim 1, line 6 recites “a surrogate syringe barrel”. Claim 1, line 1 previously recites “a drug delivery device”. It is unclear whether “a surrogate syringe barrel” is part of “a drug delivery device” or not. Claims 2-12 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, line 7 recites “a flange extender”. Claim 1, line 1 previously recites “a drug delivery device”. It is unclear whether “a flange extender” is part of “a drug delivery device” or not. Claims 2-12 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, line 8 recites “a plunger rod”. Claim 1, line 1 previously recites “a drug delivery device”. It is unclear whether “a plunger rod” is part of “a drug delivery device” or not. Claims 2-12 are rejected by virtue of being dependent upon claim 1.
In regards to claim 5, line 1 recites “the outer dimension”. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 5, line 1 recites “the ring”. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 5, lines 1-4 recite: wherein the outer dimension of the ring of the plunger rod is greater than the inner dimension of the opening of the flange extender “such that axial movement of the plunger rod towards the second end of the frame member is prevented”. It is unclear how the outer dimension of the ring of the plunger rod being greater than the inner dimension of the opening of the flange extender is “such that axial movement of the plunger rod towards the second end of the frame member is prevented”. Figure 6 instead shows that despite the outer dimension of the ring 16 of the plunger rod 10 being greater than the inner dimension of the opening 24 of the flange extender 20, axial movement of the plunger rod towards the second end 103 of the frame member 101 is allowed.
In regards to claim 13, line 6 recites “a surrogate syringe barrel”. Claim 13, line 2 previously recites “a drug delivery device”. It is unclear whether “a surrogate syringe barrel” is part of “a drug delivery device” or not. Claims 14-19 are rejected by virtue of being dependent upon claim 13.
In regards to claim 13, line 7 recites “a first flange extender”. Claim 13, line 2 previously recites “a drug delivery device”. It is unclear whether “a first flange extender” is part of “a drug delivery device” or not. Claims 14-19 are rejected by virtue of being dependent upon claim 13.
In regards to claim 13, line 8 recites “a first plunger rod”. Claim 13, lines 1-2 previously recite “a portion of a drug delivery device”. First, it is unclear whether “a first plunger rod” is the same as or different from “a portion”. Second, it is unclear whether “a first plunger rod” is part of “a drug delivery device” or not. Claims 14-19 are rejected by virtue of being dependent upon claim 13.
In regards to claim 13, line 13 recites “a maximum urging force”. Claim 13, line 1 previously recites “a maximum urging force”. It is unclear whether the two recitations are the same or different. Claims 14-19 are rejected by virtue of being dependent upon claim 13.
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.
Claims 1, 7-13, and 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dreher et al (WO 2019/110778).
In regards to claim 1, Dreher et al teaches a testing system (Figures 1-6) for a drug delivery device comprising:
a frame member (3) having a first end (at 33) and a second end (at 32)
a driving member (4/56/53b) positioned near the frame member, the driving member being movable in an axial direction (A) between the first end of the frame member and the second end of the frame member (paragraph [0076])
a surrogate syringe barrel (51) operably coupled with the of the frame member
a flange extender (58) adapted to couple with a portion of the surrogate syringe barrel
a plunger rod (53a) adapted to couple with the flange extender and be at least partially disposed within the surrogate syringe barrel while being movable therein (paragraph [0074]), the plunger rod including a first end, a second end, and a longitudinal length therebetween (Figure 4), the first end being positioned near a portion of the driving member (Figure 4)
wherein the driving member is adapted to measure a maximum urging force exerted on the plunger rod when moving in the axial direction towards the second end of the frame member (paragraph [0067])
In regards to claim 7, Dreher et al teaches wherein the surrogate syringe barrel includes a syringe flange, wherein the flange extender includes a flange adapted to rest upon the syringe flange of the surrogate syringe barrel (Figure 4).
In regards to claim 8, Dreher et al teaches wherein the frame member includes an elevated platform positioned at the first end thereof, the elevated platform adapted to retain and suspend the surrogate syringe barrel from the first end thereof (Figure 1).
In regards to claim 9, Dreher et al teaches wherein when moving the driving member towards the second end of the frame member, the plunger rod and the flange extender are subject to a gravitational force in the axial direction (Figure 1).
In regards to claim 10, Dreher et al teaches wherein the driving member includes a push pin (53b) adapted to be at least partially insertable and movable within the surrogate syringe barrel.
In regards to claim 11, Dreher et al teaches wherein the push pin includes a recessed region adapted to align with the first end of the plunger rod (Figure 4).
In regards to claim 12, Dreher et al teaches wherein the driving member is positioned above the first end of the frame member (Figure 1).
In regards to claim 13, Dreher et al teaches a method of measuring a maximum urging force experienced by a portion of a drug delivery device (paragraph [0067]), the method comprising:
positioning a driving member (4/56/53b) near a first end of a frame member (3) (Figure 1), the driving member being movable in an axial direction (A) between the first end of the frame member to a second end of the frame member (paragraph [0076])
operably coupling a surrogate syringe barrel (51) with the first end of the frame member (Figure 1)
coupling a first flange extender (58) with a portion of the surrogate syringe barrel (Figure 4)
coupling a first plunger rod (53a) with the flange extender such that the first plunger rod is at least partially movably disposed within the surrogate syringe barrel (paragraph [0074]), the first plunger rod including a first end, a second end, and a longitudinal length therebetween (Figure 4)
moving the driving member in the axial direction towards the second end of the frame member, thereby urging the first plunger rod towards the second end of the frame member (paragraphs [0076][0077])
measuring a maximum urging force exerted on the first plunger rod while moving towards the second end of the frame member (paragraph [0067])
In regards to claim 15, Dreher et al teaches the step of resting a flange of the flange extender on a syringe flange of the surrogate syringe barrel (Figure 4).
In regards to claim 16, Dreher et al teaches the step of retaining and suspending the surrogate syringe barrel from an elevated platform of the frame member positioned at the first end thereof (Figure 1).
In regards to claim 17, Dreher et al teaches wherein the step of moving the driving member towards the second end of the frame member further comprises subjecting the plunger rod and the flange extender to a gravitational force in the axial direction (Figure 1).
In regards to claim 18, Dreher et al teaches wherein the step of moving the driving member in the axial direction comprises moving a push pin (53b) within the surrogate syringe barrel (paragraph [0076]).
In regards to claim 19, Dreher et al teaches the step of aligning a recessed region of the push pin with the first end of the plunger rod (Figure 4).
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.
Claims 2-4, 6, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Dreher et al, as applied to claims 1 and 13 above, and further in view of Bryant et al (US 2019/0365565).
In regards to claim 2, Dreher et al is silent about wherein the plunger rod includes a plunger rod interface positioned along the longitudinal length thereof, the plunger rod interface adapted to engage a floor region of the flange extender to retain the plunger rod in an initial position. Bryant et al teaches a testing system (Figures 1-5) for a drug delivery device, wherein a plunger rod (4) includes a plunger rod interface (32) positioned along a longitudinal length thereof, the plunger rod interface adapted to engage a floor region (34) of a flange extender (6) to retain the plunger rod in an initial position (paragraph [0047]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the plunger rod, of the testing system of Dreher et al, to include a plunger rod interface, as taught by Bryant et al, as such will cooperate with a floor region of the flange extender to substantially prevent movement of the plunger rod away from an outlet end of the syringe barrel when the floor region and the plunger rod interface are in contact (paragraph [0047]).
In regards to claim 3, in the modified testing system of Dreher et al and Bryant et al, Dreher et al is silent about wherein the plunger rod interface includes a ring having an outer dimension. Bryant et al teaches wherein the plunger rod interface includes a ring (32) having an outer dimension (paragraph [0047]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the plunger rod interface, of the modified testing system of Dreher et al and Bryant et al, to include a ring, as taught by Bryant et al, as such will cooperate with a floor region of the flange extender to substantially prevent movement of the plunger rod away from an outlet end of the syringe barrel when the floor region and the ring are in contact (paragraph [0047]).
In regards to claim 4, in the modified testing system of Dreher et al and Bryant et al, Dreher et al is silent about wherein the floor region of the flange extender includes an opening having an inner dimension. Bryant et al teaches wherein the floor region of the flange extender includes an opening (of 34) having an inner dimension. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the floor region of the flange extender, of the modified testing system of Dreher et al and Bryant et al, to include an opening, as taught by Bryant et al, as such will cooperate with the plunger rod interface to substantially prevent movement of the plunger rod away from an outlet end of the syringe barrel when the opening and the plunger rod interface are in contact (paragraph [0047]).
In regards to claim 6, in the modified testing system of Dreher et al and Bryant et al, Dreher et al is silent about wherein at least one of the plunger rod interface or the floor region of the flange is at least partially constructed from a deformable material. Bryant et al teaches wherein the plunger rod interface is at least partially constructed from a deformable material (paragraph [0012]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the plunger rod interface, of the modified testing system of Dreher et al and Bryant et al, to be at least partially constructed from a deformable material, as taught by Bryant et al, as such is unavoidable in a bulk manufactured product (paragraph [0012]).
In regards to claim 14, Dreher et al is silent about wherein the plunger rod includes a plunger rod interface positioned along the longitudinal length thereof, the plunger rod interface adapted to engage a floor region of the flange extender to retain the plunger rod in an initial position. Bryant et al teaches a method, wherein a plunger rod (4) includes a plunger rod interface (32) positioned along a longitudinal length thereof, the plunger rod interface adapted to engage a floor region (34) of a flange extender (6) to retain the plunger rod in an initial position (paragraph [0047]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the plunger rod, of the method of Dreher et al, to include a plunger rod interface, as taught by Bryant et al, as such will cooperate with a floor region of the flange extender to substantially prevent movement of the plunger rod away from an outlet end of the syringe barrel when the floor region and the plunger rod interface are in contact (paragraph [0047]).
Allowable Subject Matter
Claim 5 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
In regards to claim 5, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a testing system for a drug delivery device, as claimed, specifically including wherein the outer dimension of the ring of the plunger rod is greater than the inner dimension of the opening of the flange extender such that axial movement of the plunger rod towards the second end of the frame member is prevented.
Dreher et al is silent about wherein the outer dimension of the ring of the plunger rod is greater than the inner dimension of the opening of the flange extender such that axial movement of the plunger rod towards the second end of the frame member is prevented.
Bryant et al teaches wherein the outer dimension of the ring (32) of the plunger rod (26) is greater than the inner dimension of the opening (of 34) of the flange extender (6) (paragraph [0047]).
However, Bryant et al does not teach a frame member “such that axial movement of the plunger rod towards the second end of the frame member is prevented”.
And in the combination of Dreher et al and Bryant et al, it would be understood that axial movement of the plunger rod (Dreher et al: 53a) away from the first end (Dreher et al: at 33) of the frame member (Dreher et al: 3) would be prevented with the outer dimension of the ring (Bryant et al: 32) of the plunger rod (Bryant et al: 26) being greater than the inner dimension of the opening (Bryant et al: of 34) of the flange extender (Bryant et al: 6).
Thus, claim 5 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b), set forth in this Office action and to include all of the limitations of the base claim 1 and intervening claims 2 and 4.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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