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
Applicant’s election without traverse of invention I in the reply filed on 4/14/2026 is acknowledged.
Applicant’s election of species A in the reply filed on 4/14/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 46 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 30-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 30-31 are drawn to species B and therefore have been withdrawn. Election was made without traverse in the reply filed on 4/14/2026.
Specification
The abstract of the disclosure is objected to because:
Line 7 as numbed by Applicant (line 3 of the abstract) recites “the liquid drug”. As the liquid drug has not previously been introduced, Examiner suggests replacing “the liquid drug” with “a liquid drug” to put the abstract in clearer form.
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).
The disclosure is objected to because of the following informalities:
Page 1, line 6 mentions U.S. patent application 16/479,790. Application 16/479,790 has been patented as U.S. patent no 11872381. The specification should be amended to include that application 16/479,790 has been patented as U.S. patent no 11872381.
Appropriate correction is required.
Claim Objections
Claim 44 objected to because of the following informalities:
Line 2 recites “wherein the drive train comprises”. Examiner suggests replacing “wherein the drive train comprises” with “wherein the drive train comprises:” to put the claim in clearer form.
Claim 45 objected to because of the following informalities:
Line 2-3 recites “a drug container”. Line 2 recites “a drug container”. If the drug container of line 2-3 is the same as the drug container of line 2, Examiner suggests replacing “a drug container” in line 2-3 with “the drug container” to put the claim in clearer form as antecedent basis is already provided for the drug container in line 2-3. If intended to be broad, no amendment is needed.
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 27-28 and 31-45 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 regard to claim 27,
Line 4-5 recites “from a proximal”. It is unclear if “a proximal” is intended to be “a proximal end” or “a proximal structure” or a “proximal portion” or a different structure. For examination purposes Examiner construes “a proximal” to be “a proximal end”. Examiner suggests replacing “from a proximal” in line 4-5 of claim 27 with “from a proximal end”.
Examiner notes claim 28 and 31-43 are similarly rejected by virtue of their dependency on claim 27.
In regard to claim 35,
Line 4 recites “an inner surface of the drive sleeve”. Line 1-2 recites “wherein the dampening element is arranged between an inner surface of a proximal portion of the drive sleeve”. It is unclear if the inner surface of the drive sleeve of line 4 is the same as the inner surface of a proximal portion of the drive sleeve (since the dampening element is arranged between the inner surface of a proximal portion of the drive sleeve) or if the inner surface of the drive sleeve is a different inner surface for example an inner surface of a distal portion of the drive sleeve. For examination purposes Examiner construes the inner surface of line 4 and line 2 to be the same. Examine suggests replacing “an inner surface of the drive sleeve” in line 4 of claim 35 with “the inner surface of the proximal portion of the drive sleeve”. If intended to be different, Examiner suggests amending line 4 to claim which inner surface of the drive sleeve “an inner surface of the drive sleeve” for example an inner surface of a distal portion of the drive sleeve.
In regard to claim 39,
Line 2-3 recites “wherein the clutch element is coupled with the torsional energy storage via the number sleeve”. It is unclear what is meant by this. Claim 39 depends on claim 32 and claim 27. The torsional energy storage as claimed in claim 27 comprises a first rotatable element. As claimed in claim 32 the first rotatable element comprises a clutch element. It is unclear how the clutch element would be coupled to the torsional energy storage via the number sleeve as the clutch element is a component of the torsional energy storage. For examination purposes Examiner construes “wherein the clutch element is coupled with the torsional energy storage via the number sleeve” to be “wherein the clutch element is coupled with the housing of the torsional energy storage via the number sleeve”. Examiner suggests clarifying what is meant in claim 39.
In regard to claim 41,
Line 1-7 recites “wherein the cutch element comprises a ratchet for maintaining a number sleeve at one of a number of discrete angular positions against a torque of the torsional energy storage, wherein the clutch element is adapted to transmit a torque from the user handle via the number sleeve to the torsional energy storage or alternatively from the torsional energy storage via the number sleeve to the expelling mechanism, and wherein the ratchet is switchable from one position to an adjacent position by the torque transmitted from the user handle to the torsional energy storage”. It is unclear what is meant by this. Claim 41 depends on claim 32 and claim 27. The torsional energy storage as claimed in claim 27 comprises a first rotatable element. As claimed in claim 32 the first rotatable element comprises a clutch element. It is therefore unclear as the clutch element is a component of the torsional energy storage how the cutch element comprises a ratchet for maintaining a number sleeve at one of a number of discrete angular positions against a torque of the torsional energy storage, wherein the clutch element is adapted to transmit a torque from the user handle via the number sleeve to the torsional energy storage or alternatively from the torsional energy storage via the number sleeve to the expelling mechanism, and wherein the ratchet is switchable from one position to an adjacent position by the torque transmitted from the user handle to the torsional energy storage. For examination purposes Examiner construes the torsional energy storage in claim 41 to be a portion of the torsional energy storage. Examiner suggests clarifying which portion of the torsional energy storage is being referred to in claim 41 as the torsional energy storage as claimed would include the clutch with the ratchet.
In regard to claim 43,
Line 2-3 recites “an element of the drive train”. Claim 43 is dependent on claim 27. Claim 27 introduces several elements of the drive train i.e. a torsional energy storage, a first rotatable element, a rotatable user handle, a rotationally driveable expelling mechanism, a second rotatable element, and a dampening element. The element of the drive train in claim 43 is introduced as an additional element. However, based on the disclosure, it appears the element of the drive train would be the same as the second rotatable element. Therefore, it is unclear if claim 43 is attempting to refer to an element already introduced or to introduce an additional element of the drive train. For examination purposes Examiner construes “an element of the drive train” to be “an element of the drive train which is the second rotatable element”. Examiner suggests replacing “an element of the drive train” in line 2-3 of claim 43 with “an element of the drive train which is the second rotatable element” or “the second rotatable element”.
Line 3 recites “that element”. Claim 43 is dependent on claim 27. Claim 27 introduces a first rotatable element and a second rotatable element. It is unclear if “that element” refers to the element of the drive train, the first rotatable element, or the second rotatable element. For examination purposes Examiner construes “that element” to be “the element of the drive train” which is the second rotatable element. Examiner suggests amending line 3 of claim 43 to replace “that element” with “the element of the drive train” or “the second rotatable element”.
In regard to claim 44,
Line 4-5 recites “from a proximal”. It is unclear if “a proximal” is intended to be “a proximal end” or “a proximal structure” or a “proximal portion” or a different structure. For examination purposes Examiner construes “a proximal” to be “a proximal end”. Examiner suggests replacing “from a proximal” in line 4-5 of claim 44 with “from a proximal end”.
Examiner notes claim 45 is similarly rejected by virtue of its dependency on claim 44.
In regard to claim 45,
Line 2 and line 3 recite “a drug”. Claim 45 depends on claim 44. Claim 44 recites “a liquid drug”. It is unclear if the drug of line 2 and line 3 are additional drugs to the liquid drug or if the drug of line 2 and line 3 are the same as the liquid drug. For examination purposes Examiner construes them to be the same as the liquid drug. Examiner suggests replacing “a drug” in line 2 and line 3 of claim 45 with “the liquid drug”.
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.
Claims 27-29, 32-41, and 44-45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hansen (U.S. PG publication 20140350478).
In regard to claim 27,
Hansen discloses a drive train (figure 1-9, item 10, 20, 40, 50, torsion spring and housing not shown in figures but described in paragraph [0051], and a driver not shown in figures but disclosed in paragraph [0065]) for a wind-up injection device (paragraph [0001]) for injecting a liquid drug (paragraph [0013]), wherein the drive train comprises:
a torsional energy storage (housing described in paragraph [0051], wherein the housing includes a torsion spring, and item 20 not including item 30 and 32; Examiner notes the housing and item 20 not including item 30 and 32 collectively form the torsional energy storage) wherein the torsional energy storage comprises a first rotatable element (figure 2 and 8, item 20 not including item 30 and 32; paragraph [0051]) and a housing (housing described in paragraph [0051]), wherein the housing includes a longitudinal axis extending from a proximal towards a distal end (paragraph [0012] and [0050]-[0051]);
a rotatable user handle (figure 5, item 40; paragraph [0063]);
a rotationally driveable expelling mechanism (figure 2 and 8, item 10 and driver described in paragraph [0065]) adapted to expel the liquid drug (paragraph [0065] and [0013]), wherein the expelling mechanism comprises a second rotatable element (figure 2 and 8, item 10) arranged within the housing (paragraph [0050]) and rotatable around the longitudinal axis (paragraph [0065]); and
a dampening element (figure 6, item 30 and 32; paragraph [0066] and [0072]), wherein the dampening element is arranged between the first rotatable element and the second rotatable element (paragraph [0066]; see figure 9).
In regard to claim 28,
Hansen discloses the drive train according to claim 27, wherein the first rotatable element is rotationally locked relative to the second rotatable element during a dispensing operation (paragraph [0065]).
In regard to claim 29,
Hansen discloses the drive train according to claim 27, wherein the first rotatable element is rotatable relative to the second rotatable element during a wind-up operation (paragraph [0057], [0061] and [0063]).
In regard to claim 32,
Hansen discloses the drive train according to claim 27, wherein the first rotatable element comprises a clutch element (figure 2 and 8, item 20 not including item 30 and 32) and the second rotatable element comprises a drive sleeve (figure 2 and 8, item 10), and wherein the dampening element is adapted to frictionally resist a rotation of the clutch element relative to the drive sleeve around the longitudinal axis (paragraph [0065] and [0072]-[0073]).
In regard to claim 33,
Hansen discloses the drive train according to claim 32, wherein the clutch element comprises a cylindrical clutch section (see figure 6), and wherein the dampening element is arranged in a radial direction directly between the drive sleeve and the cylindrical clutch section (see figure 8 and 9).
In regard to claim 34,
Hansen discloses the drive train according to claim 32, wherein a proximal portion of the drive sleeve is adapted to receive a distal portion of the clutch element coaxially to the longitudinal axis (see figure 8).
In regard to claim 35,
Hansen discloses the drive train according to claim 32, wherein the dampening element is arranged between an inner surface of a proximal portion of the drive sleeve and an outer surface of a distal portion of the clutch element (see figure 6 and 9), and wherein the dampening element is adapted to frictionally engage an inner surface of the drive sleeve (see figure 9).
In regard to claim 36,
Hansen discloses the drive train according to claim 32, wherein the dampening element is received in a toric space formed by a first circumferential recess (see figure 6 wherein item 30 is within a recess of item 20) provided in the clutch element (see figure 6) and a radially adjacent second circumferential recess (see figure 9 wherein item 10 has a radially adjacent second circumferential recess) provided in an inner surface of the drive sleeve (See figure 9).
In regard to claim 37,
Hansen discloses the drive train according to claim 32, wherein a radially inwardly directed face of the dampening element frictionally engages the clutch element (see figure 6), and wherein a radially outwardly directed face of the dampening element frictionally engages the drive sleeve (see figure 9).
In regard to claim 38,
Hansen discloses the drive train according to claim 32, wherein the housing includes a torsional drive spring (torsion spring; paragraph [0051]) with a distal spring end non-rotatably engaged to the housing (paragraph [0051]) and with a proximal spring end torsionally tensible around the longitudinal axis relative to the housing (paragraph [0051]), and wherein the clutch element is adapted to releasably non-rotatably couple the proximal spring end of the drive spring with the drive sleeve (paragraph [0051] and [0065]).
In regard to claim 39,
Hansen discloses the drive train according to claim 32, wherein the drive train comprises a tubular number sleeve (figure 8, item 50; paragraph [0068]) adapted to at least partially receive the clutch element (see figure 8), wherein the clutch element is coupled with the torsional energy storage (coupled to the housing of the torsional energy storage) via the number sleeve (paragraph [0069]), and wherein the dampening element (item 32 of the dampening element) is arranged in a radial direction between the number sleeve and the clutch element (paragraph [0070]).
In regard to claim 40,
Hansen discloses the drive train according to claim 32, wherein the dampening element (item 32 and 30) is arranged in a radial direction between the user handle and the clutch element (see figure 1 and 2; paragraph [0059]).
In regard to claim 41,
Hansen discloses the drive train according to claim 32, wherein the cutch element comprises a ratchet (figure 4, item 21) for maintaining a number sleeve (figure 8, item 50; paragraph [0068]) at one of a number of discrete angular positions against a torque of the torsional energy storage (paragraph [0055]-[0056] and [0020] wherein the number sleeve/dose indicator rotates with the clutch element/ratchet tube and is therefore held in position when the clutch element/ratchet tube is held in position), wherein the clutch element is adapted to transmit a torque from the user handle via the number sleeve to the torsional energy storage or alternatively from the torsional energy storage via the number sleeve to the expelling mechanism (Examiner notes “adapted to transmit a torque from the user handle via the number sleeve to the torsional energy storage or alternatively from the torsional energy storage via the number sleeve to the expelling mechanism” is a functional limitation. The clutch element is fully capable of the recited function due to its structure as the clutch element is adapted to transmit a torque from the user handle via the number sleeve to the housing of the torsional energy storage), and wherein the ratchet is switchable from one position to an adjacent position by the torque transmitted from the user handle to the torsional energy storage (paragraph [0052] and [0055]-[0056]).
In regard to claim 44,
Hansen discloses a wind-up injection device (paragraph [0001]) for injecting a liquid drug (paragraph [0013]) comprising a drive train (figure 1-9, item 10, 20, 40, 50, torsion spring and housing not shown in figures but described in paragraph [0051], and a driver not shown in figures but disclosed in paragraph [0065]), wherein the drive train comprises
a torsional energy storage (housing described in paragraph [0051], wherein the housing includes a torsion spring, and item 20 not including item 30; Examiner notes the housing and item 20 not including item 30 collectively form the torsional energy storage), wherein the torsional energy storage comprises a first rotatable element (figure 2 and 8, item 20 not including item 30; paragraph [0051]) and a housing (housing described in paragraph [0051]), wherein the housing includes a longitudinal axis extending from a proximal towards a distal end (paragraph [0012] and [0050]-[0051]);
a rotatable user handle (figure 5, item 40; paragraph [0063]);
a rotationally driveable expelling mechanism (figure 2 and 8, item 10 and driver described in paragraph [0065]) adapted to expel the liquid drug (paragraph [0065] and [0013]), wherein the expelling mechanism comprises a second rotatable element (figure 2 and 8, item 10) arranged within the housing (paragraph [0050]) and rotatable around the longitudinal axis (paragraph [0065]); and
a dampening element (figure 6, item 30; paragraph [0066] and [0072]), wherein the dampening element is arranged between the first rotatable element and the second rotatable element (paragraph [0066]; see figure 9).
In regard to claim 45,
Hansen discloses the wind-up injection device according to claim 44, wherein the wind-up injection device is configured to retain a drug container with a drug or comprises a drug container with a drug (paragraph [0027] and [0030]).
Claims 27-29 and 42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haber (U.S. Patent no 5271527).
In regard to claim 27,
Haber discloses a drive train (figure 1, item 4 and figure 2, item 100, 104, 106, 140, 114) for a wind-up injection device (figure 1, item 2) for injecting a liquid drug (column 3, line 19-21), wherein the drive train comprises:
a torsional energy storage (figure 1, item 4 and figure 2, item 100; Examiner notes item 4 and 100 are construes as a torsional energy storage as they store/house torsional energy of item 102), wherein the torsional energy storage comprises a first rotatable element (figure 2, item 100; Examiner notes item 100 is rotatable by rotating the housing/device) and a housing (figure 1, item 4), wherein the housing includes a longitudinal axis extending from a proximal towards a distal end (see figure 1);
a rotatable user handle (figure 2, item 114; column 8, line 2-12);
a rotationally driveable expelling mechanism (figure 2, item 106; column 10, line 54-64; Examiner notes item 106 is a component of dose adjuster 102 and item 106 has threads which mates with drive coupling 108; column 7, line 64-column 8, line 2; Examiner notes item 106 functions with other components to expel the liquid drug) adapted to expel the liquid drug (column 10, line 54-64), wherein the expelling mechanism comprises a second rotatable element (figure 2, item 106) arranged within the housing (see figure 1) and rotatable around the longitudinal axis (column 8, line 24-45); and
a dampening element (figure 2, item 140), wherein the dampening element is arranged between the first rotatable element and the second rotatable element (see figure 6).
In regard to claim 28,
Haber discloses the drive train according to claim 27, wherein the first rotatable element is rotationally locked relative to the second rotatable element during a dispensing operation (column 10, line 54-64; column 9, line 5-10).
In regard to claim 29,
Haber discloses the drive train according to claim 27, wherein the first rotatable element is rotatable relative to the second rotatable element during a wind-up operation (column 8, line 24-45).
In regard to claim 42,
Haber discloses the drive train according to claim 27, wherein the dampening element is formed as an O-ring (see figure 6, item 140; column 9, line 5-10).
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.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Haber (U.S. Patent no 5271527) further in view of Haber (U.S. Patent no 5320609). For clarity purposes Haber (U.S. Patent no 5320609) will be referred to as Haber609.
In regard to claim 43,
Haber discloses the drive train according to claim 27, wherein the dampening element comprises at least one surface of elastic material (column 16, line 33-35) adapted to slide along a contact surface of an element (figure 2, item 106) of the drive train when rotated relatively to that element (column 9, line 5-10; Examiner notes “adapted to slide along a contact surface of an element of the drive train when rotated relatively to that element” is a functional limitation. The at least one surface is fully capable of the recited function due to it structure).
Haber is silent as to the elastic material specifically being elastic rubber and therefore is silent as to wherein the dampening element comprises at least one surface of elastic rubber.
Haber609 teaches at least one surface (surface of o-ring; column 4, line 55-57) that is elastic rubber (column 4, line 55-57).
Therefore, 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 dampening element of Haber to substitute a rubber material in place of the elastic material therefore resulting in wherein the dampening element comprises at least one surface of elastic rubber, as taught by Haber609, because the substitution is a simple substitution that would yield the same predictable result of providing a suitable elastic o-ring. Furthermore, Haber discloses modifications can be made (column 16, line 39-41 of Haber).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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