DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 21 is objected to because of the following informalities: The phrase “the sleeve of the body” on line 2 should be amended to recite either just “the sleeve” or “the body” since claim 20 sets forth that the “body” is a “sleeve”. The term “flexible” should be inserted before the phrase “mounting tab” on line 7 to match the language used earlier in the claim. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: The phrase “the cylindrical sleeve” should be replaced with the phrase “the sleeve” since claim 25 does not specify that the “sleeve” is “cylindrical”. Alternatively, claim 25 could be amended to recite “a cylindrical sleeve” instead of “a sleeve” and claim 27 could be maintained as is. 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 17 and 18 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.
Re claims 17 and 18, each of these claims recite “neighboring coil sections”. It is unclear if these “neighboring coil sections” are intended to be some of the “plurality of coil sections” of the “power spring” recited in claim 15 or different therefrom. For the sake of examination, they are interpreted as being the same. Accordingly, it is suggested to amend claims 17 and 18 to recite “neighboring coil sections of the plurality of coil sections of the power spring”.
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.
(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.
Claims 15, 17, 19, 22-24 and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grunhut et al. (PG PUB 2009/0312705).
Re claim 15, Grunhut discloses a power pack 19+23+28+30+32 (Fig 2,3 but wherein the click generator 32 is of the form seen in Fig 15 instead of the form seen in Fig 2,3; it is noted that all reference characters cited below refer to Fig 15 unless otherwise noted) for a medicament delivery device (it is noted that the phrase “for a medicament delivery device” is functional language and, therefore, a “medicament delivery device” is not a part of the claimed invention), comprising: a tubular body 19 (Fig 2,3) extending along a longitudinal axis (extending vertically in Fig 2,3,15) from a proximal end (at the bottom of Fig 2,3) to a distal end (at the top of Fig 2,3), the tubular body including an inner tubular section 19a arranged fixed relative to the tubular body (Para 87) and also extending along the longitudinal axis (as seen in Fig 2,3); a plunger rod 28 at least partially arranged within the inner tubular section (as seen in Fig 15) and movable relative to the inner tubular section along the longitudinal axis (Para 125,126); a power spring 30 including a plurality of coil sections (as seen in Fig 15), the power spring being at least partially arranged within the inner tubular section (as seen in Fig 15) and expandable along the longitudinal axis (as seen in Fig 2,3) and, in a compressed state, at least partially surrounding the plunger rod (as seen in Fig 15) such that the power spring, when released and expanding along the longitudinal axis during activation of the power pack, drives the plunger rod along the longitudinal axis towards the proximal end (Para 125,126), and a click generator 32 mounted to the tubular body (as seen in Fig 15, Para 129) and including a flexible arm (labeled in Fig A below), the flexible arm at least partially extending radially inwards long enough towards the longitudinal axis (as seen in Fig 15) such that when the power spring expands, at least some coil sections of the plurality of coil sections of the power spring and the flexible arm repeatedly collide when the at least some coil sections move towards the proximal end, thereby causing a repeated bending and release of the flexible arm (Para 127,128), wherein the flexible arm has a stiffness high enough such that the repeated colliding of the at least some coil sections and the flexible arm, and/or said repeated bending and release of the flexible arm, generates a plurality of clicking sounds (Para 128).
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Re claim 17, Grunhut discloses that a thickness of the flexible arm is smaller than a distance between neighboring coil sections in the compressed state of the power spring (as seen in Fig 15).
Re claim 19, Grunhut discloses that the click generator is mounted to a proximal end of the inner tubular section (as seen in Fig 15, Para 129).
Re claim 22, Grunhut discloses a release button 23 (Fig 2,3) arranged within the tubular body (as seen in Fig 2,3) and movable relative to the tubular body along the longitudinal axis (Para 105), and configured to, if pushed along the longitudinal axis towards the proximal end, cause the activation of the power pack by releasing the power spring (Para 105).
Re claim 23, Grunhut discloses that the inner tubular section includes a distal flexible arm 21 (Fig 3, Para 87) configured to abut a distal rim 29 (Fig 3) of the plunger rod to block the power spring from being released and the plunger rod from moving along the longitudinal axis towards the proximal end (Para 106), and the release button includes a protrusion 25 (Fig 3) extending from a distal end of the release button towards the proximal end of the tubular body (as seen in Fig 3), and configured to, as a result of pushing the release button along the longitudinal axis towards the proximal end, abut a distal surface of the flexible arm (as seen in Fig 3) of the inner tubular section and cause a bending of the flexible arm of the inner tubular section radially outwards and away from the longitudinal axis (Para 118), thereby causing the activation of the power pack by preventing the blocking of the power spring from being released and the plunger rod from moving along the longitudinal axis towards the proximal end (Para 119).
Re claim 24, Grunhut discloses that during the expansion of the power spring, a proximal end of the power spring abuts a proximal rim 28a (Fig 3) of the plunger rod, thus driving the plunger rod along the longitudinal axis towards the proximal end of the power pack (Para 90).
Re claim 28, Grunhut discloses a medicament delivery device 1 (Fig 1,2), comprising a power pack according to claim 15 (see the rejection of claim 15 above).
Claims 15-17, 19, 20, 24-26 and 28 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Holmqvist (PG PUB 2023/0390493)1.
Re claim 15, Holmqvist discloses a power pack 48+90+96+150 (Fig 1,2,19,20) for a medicament delivery device (it is noted that the phrase “for a medicament delivery device” is a functional limitation and, therefore, a “medicament delivery device” is not a part of the claimed invention), comprising: a tubular body (the entirety of 48 except for tubular section 54, Fig 8) extending along a longitudinal axis (extending horizontally in Fig 1,2) from a proximal end (to the left in Fig 1,2) to a distal end (to the right in Fig 1,2), the tubular body including an inner tubular section 54 (Fig 8,20) arranged fixed relative to the tubular body (as seen in Fig 8) and also extending along the longitudinal axis (as seen in Fig 1,2); a plunger rod 90 (Fig 2,20) at least partially arranged within the inner tubular section (as seen in Fig 20) and movable relative to the inner tubular section along the longitudinal axis (Para 52); a power spring 96 (Fig 1,20) including a plurality of coil sections (as seen in Fig 20), the power spring being at least partially arranged within the inner tubular section (as seen in Fig 20) and expandable along the longitudinal axis (Para 52) and, in a compressed state, at least partially surrounding the plunger rod (as seen in Fig 2,20; Para 48) such that the power spring, when released and expanding along the longitudinal axis during activation of the power pack, drives the plunger rod along the longitudinal axis towards the proximal end (Para 52), and a click generator 150 (Fig 19,20) mounted to the tubular body (as seen in Fig 20) and including a flexible arm 156 (Fig 19), the flexible arm at least partially extending radially inwards long enough towards the longitudinal axis (as seen in Fig 20) such that when the power spring expands, at least some coil sections of the plurality of coil sections of the power spring and the flexible arm repeatedly collide when the at least some coil sections move towards the proximal end, thereby causing a repeated bending and release of the flexible arm (Para 45,54), wherein the flexible arm has a stiffness high enough such that the repeated colliding of the at least some coil sections and the flexible arm, and/or said repeated bending and release of the flexible arm, generates a plurality of clicking sounds (Para 54).
Re claim 16, Holmqvist discloses that the flexible arm is made from a sheet metal (Para 45).
Re claim 18, Holmqvist discloses that a thickness of the flexible arm is smaller than a distance between neighboring coil sections in the compressed state of the power spring (as seen in Fig 20).
Re claim 19, Holmqvist discloses that the click generator is mounted to a proximal end of the inner tubular section (as seen in Fig 20, Para 45).
Re claim 20, Holmqvist discloses that a body 152 (Fig 19) of the click generator is formed as a sleeve (as seen in Fig 19,20), and the sleeve is mounted to the proximal end of the inner tubular section (as seen in Fig 20, Para 45).
Re claim 24, Holmqvist discloses that during the expansion of the power spring, a proximal end of the power spring abuts a proximal rim 94 (Fig 13) of the plunger rod (as seen in Fig 6), thus driving the plunger rod along the longitudinal axis towards the proximal end of the power pack (Para 41).
Re claim 25, Holmqvist discloses a click generator 150 (Fig 19) for a power pack for a medicament delivery device (it is noted that the phrase “for a power pack for a medicament delivery device” is a functional limitation and, therefore, a “power pack” and “a medicament delivery device” are not a part of the claimed invention), extending along a longitudinal axis (extending vertically in Fig 19) from a proximal end (at the bottom of Fig 19) to a distal end (at the top of Fig 19), and comprising: a body 152 (Fig 19) extending along the longitudinal axis and formed as a sleeve (as seen in Fig 19,20; Para 45), and a flexible arm 156 (Fig 19) arranged at the proximal end and at least partially extending radially inwards towards the longitudinal axis (as seen in Fig 19,20), wherein the flexible arm has a stiffness high enough such that a repeated colliding of the flexible arm and coil sections of a power spring of the power pack, and/or a repeated bending and release of the flexible arm, causes generation of a plurality of clicking sounds (Para 54).
Re claim 26, Holmqvist discloses that he flexible arm is made from a sheet metal (Para 45).
Re claim 28, Holmqvist discloses a medicament delivery device 10 (Fig 1,2), comprising a power pack according to claim 15 (see the rejection of claim 15 above).
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 16, 20, 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Grunhut et al. (PG PUB 2009/0312705) in view of Holmqvist (PG PUB 2023/0390493).
Re claim 16, Grunhut discloses all the claimed features except that the flexible arm is made from a sheet metal. Holmqvist, however, teaches a power pack comprising a click generator 150 (Fig 19,20) including a flexible arm 156 (Fig 19,20) that is configured to collide with coil sections of a power spring 96 (Fig 20) to produce a plurality of clicking sounds (Para 54), wherein the flexible arm is made from a sheet metal (Para 45). Since Holmqvist teaches that its flexible arm – made from a sheet metal – functions the same as Grunhut’s flexible arm, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Holmqvist’s flexible arm to be made from a sheet metal 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.
Re claim 20, Grunhut discloses that a body of the click generator (labeled in Fig A above) is mounted to the proximal end of the inner tubular section (as seen in Fig 15, Para 129) but does not disclose that the body is formed as a sleeve. Holmqvist, however, teaches a power pack comprising a click generator 150 (Fig 19,20) having a flexible arm 156 (Fig 19,20) and a body 152 (Fig 19,20) formed as a sleeve (as seen in Fig 20) that is mounted to the proximal end 54 (Fig 20) of an inner tubular section 48 (Fig 8) (as seen in Fig 20) wherein the sleeve allows the click generator to mounted via a lock washer function (Para 45). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Grunhut to include the body as a sleeve, as taught by Holmqvist, for the purpose of allowing the click generator to be mounted via a lock washer function (Para 45).
Re claim 25, Grunhut discloses a click generator 32 (Fig 15) for a power pack for a medicament delivery device (it is noted that the phrase “for a power pack for a medicament delivery device” is a functional recitation and, therefore, neither a “power pack” nor a “medicament delivery device” are a part of the claimed invention; this also means that the “coil sections of a power spring of the power pack” functionally recited later on in the claim is also not a part of the claimed invention), extending along a longitudinal axis (extending vertically in Fig 15) from a proximal end (toward the bottom in Fig 15) to a distal end (toward the top in Fig 15) , and comprising: a body (labeled in annotated Fig A above) extending along the longitudinal axis, and a flexible arm (labeled in annotated Fig A above) arranged at the proximal end and at least partially extending radially inwards towards the longitudinal axis (as seen in Fig 15), wherein the flexible arm has a stiffness high enough such that a repeated colliding of the flexible arm and coil sections of a power spring of the power pack, and/or a repeated bending and release of the flexible arm, causes generation of a plurality of clicking sounds (Para 45,54). Grunhut does not disclose that the body is formed as a sleeve. Holmqvist, however, teaches a power pack comprising a click generator 150 (Fig 19,20) having a flexible arm 156 (Fig 19,20) and a body 152 (Fig 19,20) formed as a sleeve (as seen in Fig 20) that is mounted to the proximal end 54 (Fig 20) of an inner tubular section 48 (Fig 8) (as seen in Fig 20) wherein the sleeve allows the click generator to mounted via a lock washer function (Para 45). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Grunhut to include the body as a sleeve, as taught by Holmqvist, for the purpose of allowing the click generator to be mounted via a lock washer function (Para 45).
Re claim 26, Grunhut discloses all the claimed features except that the flexible arm is made from a sheet metal. Holmqvist, however, teaches a power pack comprising a click generator 150 (Fig 19,20) including a flexible arm 156 (Fig 19,20) that is configured to collide with coil sections of a power spring 96 (Fig 20) to produce a plurality of clicking sounds (Para 54), wherein the flexible arm is made from a sheet metal (Para 45). Since Holmqvist teaches that its flexible arm – made from a sheet metal – functions the same as Grunhut’s flexible arm, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Holmqvist’s flexible arm to be made from a sheet metal 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.
Claim 21 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Grunhut et al. (PG PUB 2009/0312705)/Holmqvist (PG PUB 2023/0390493) in view of Van Der Wal et al. (EP 2 421 492)2.
Re claim 21, Grunhut discloses that the sleeve is mounted to the proximal end of the inner tubular section (as seen in Fig 15, Para 129), but Grunhut/Holmqvist are both silent as to the inner tubular section being made of a plastic material and how the sleeve is mounted. Therefore, Grunhut/Holmqvist does not disclose that this mounting is performed by at least one mounting tab of the sleeve gripping into plastic material of the inner tubular section, wherein the at least one mounting tab is bent radially inwards towards the longitudinal axis and pointing towards the proximal end of the tubular body. Van Der Wal, however, teaches providing a metal sleeve 36 (Fig 1; “steel”, Para 22) with a flexible mounting tab 37 (Fig 1) that is bent radially inward and pointed toward a proximal end (as seen in Fig 1) and that is capable of gripping into the outer surface of a plastic tubular section (“piercing pin made of plastic” – Para 27) running through the center of the sleeve (Para 27) for the purpose of preventing the sleeve and the tubular section from separating from each other (Para 27). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Holmqvist to include the sleeve with at least one flexible mounting tab that is configured to grip into the plastic material of the inner tubular section, as taught by Van Der Wal, for the purpose of preventing the sleeve and the tubular section from separating from each other (Para 27).
Re claim 27, Grunhut as modified by Holmqvist in the rejection of claim 25 above disclose all the claimed features except that the sleeve further comprises at least one flexible mounting tab bent radially inwards towards the longitudinal axis and pointing towards the proximal end. Van Der Wal, however, teaches providing a metal sleeve 36 (Fig 1; “steel”, Para 22) with a flexible mounting tab 37 (Fig 1) that is bent radially inward and pointed toward a proximal end (as seen in Fig 1) and that is capable of gripping into the outer surface of a plastic tubular section (“piercing pin made of plastic” – Para 27) running through the center of the sleeve (Para 27) for the purpose of preventing the sleeve and the tubular section from separating from each other (Para 27). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Holmqvist to include the sleeve with at least one flexible mounting tab that is configured to grip into the inner tubular section, as taught by Van Der Wal, for the purpose of preventing the sleeve and the tubular section from separating from each other (Para 27).
Claims 21 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist (PG PUB 2023/0390493) in view of Van Der Wal et al. (EP 2 421 492).
Re claim 21, Holmqvist discloses that the sleeve is mounted to the proximal end of the inner tubular section (as seen in Fig 20, Para 45), but Holmqvist are both silent as to the inner tubular section being made of a plastic material and that this mounting is performed by at least one mounting tab of the sleeve gripping into plastic material of the inner tubular section, wherein the at least one mounting tab is bent radially inwards towards the longitudinal axis and pointing towards the proximal end of the tubular body. Van Der Wal, however, teaches providing a metal sleeve 36 (Fig 1; “steel”, Para 22) with a flexible mounting tab 37 (Fig 1) that is bent radially inward and pointed toward a proximal end (as seen in Fig 1) and that is capable of gripping into the outer surface of a plastic tubular section (“piercing pin made of plastic” – Para 27) running through the center of the sleeve (Para 27) for the purpose of preventing the sleeve and the tubular section from separating from each other (Para 27). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Holmqvist to include the sleeve with at least one flexible mounting tab that is configured to grip into the plastic material of the inner tubular section, as taught by Van Der Wal, for the purpose of preventing the sleeve and the tubular section from separating from each other (Para 27).
Re claim 27, Holmqvist discloses all the claimed features except that the sleeve further comprises at least one flexible mounting tab bent radially inwards towards the longitudinal axis and pointing towards the proximal end. Van Der Wal, however, teaches providing a metal sleeve 36 (Fig 1; “steel”, Para 22) with a flexible mounting tab 37 (Fig 1) that is bent radially inward and pointed toward a proximal end (as seen in Fig 1) and that is capable of gripping into the outer surface of a plastic tubular section (“piercing pin made of plastic” – Para 27) running through the center of the sleeve (Para 27) for the purpose of preventing the sleeve and the tubular section from separating from each other (Para 27). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Holmqvist to include the sleeve with at least one flexible mounting tab that is configured to grip into the inner tubular section, as taught by Van Der Wal, for the purpose of preventing the sleeve and the tubular section from separating from each other (Para 27).
Allowable Subject Matter
Claim 18 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.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of dependent claim 18 in combination with the subject matter of claim 15 could not be found nor was suggested in the prior art of record. Specifically, claim 18 requires the flexible arm [of the click generator] to have a thickness that is greater than a distance between neighboring coil sections [of the plurality of coil sections of the power spring] in the compressed state of the power spring but that is smaller than a distance between neighboring coil sections [of the plurality of coil sections of the power spring] during only part of the expansion of the power spring. A power pack having a flexible arm with such a thickness could not be found nor was suggested in the prior art of record. Applicant’s disclosure provides criticality to this thickness in paragraph [0040] which states that having such a thickness ensures that a clicking sound generation is produced only towards an end of the injection process; since criticality is provided to this thickness, it would not have been obvious to one of ordinary skill in the art at the time the invention was made to modify the flexible arm’s thickness to meet the claimed limitation absent an explicit teaching to do so.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. PG PUB 2023/0218827 to Scheurer et al., PG PUB 2021/0299359 to Quinn et al., PG PUB 2021/0236732 to Chu et al., PUB 2004/0054326 to Hommann et al., and US Pat 5,127,906 to Landry Jr et al. each disclose a power pack for a medicament delivery device comprising a click generator that provides clicking sounds throughout plunger movement during medicament delivery.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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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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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 Effective filing date November 13, 2020
2 A copy and English translation of this reference has been provided with this Office Action.
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