DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. The claim recites “during the dose setting” and “during the dose correcting.” These phrases lack antecedent basis in the claim. The operational modes were earlier introduced without the definite article (“during dose setting and dose correcting” and “during dose setting, dose correcting, and dose injecting”).
Claim 2 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. The claim recites “during the dose injecting.” This phrase lacks antecedent basis in the claim or in claim 1.
Claim 3 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. The claim recites “during the dose setting, the dose correcting and the dose injecting.” These phrases lack antecedent basis in the claim or in claim 1.
Claim 4 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. The claim recites “during the dose injecting.” This phrase lacks antecedent basis in the claim or in claim 1.
Claim 6 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. The claim recites “during the dose correcting.” This phrase lacks antecedent basis in the claim or in claim 1.
Claim 7 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. The claim recites “during the dose injecting” and “the engaging between the brake tower and the driver.” These phrases lack antecedent basis in the claim or in claims 1 and 6.
Claim 8 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. The claim recites “the dose injecting.” This phrase lacks antecedent basis in the claim or in claim 1.
Claim 9 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. The claim recites “during the dose setting and the dose correcting.” These phrases lack antecedent basis in the claim or in claim 1.
Claim 10 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. The claim recites “during the dose injecting” (twice). These phrases lack antecedent basis in the claim or in claim 1.
Claim 11 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. The claim recites “during the dose injecting.” This phrase lacks antecedent basis in the claim or in claim 1.
Claim 14 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. The claim recites “during the injecting.” This phrase lacks antecedent basis anywhere in the claims. Additionally, the phrases “the thread of the lead screw” and “the groove of the piston rod” lack proper antecedent basis.
Claim 15 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. The claim recites “during the dose setting.” This phrase lacks antecedent basis in the claim or in claim 1.
Claim 16 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. The claim recites “during the dose correcting.” This phrase lacks antecedent basis in the claim or in claim 1.
Claim 17 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. The claim recites “during the dose injecting.” This phrase lacks antecedent basis in the claim or in claim 1. Additionally, the claim twice recites “the break tower” (and “the distal end of the break tower”). These terms lack antecedent basis because the element was introduced in claim 5 as “a brake tower,” and the spelling “break tower” instead of “brake tower” renders it unclear whether the same element is intended.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Independent claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 9,937,294. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 2 of the cited patent [which depends from claim 1] discloses in claim 1, a medication injection pen comprising:
a housing;
a push button at a proximal end of said housing;
a dose set knob (DSK) comprising at least one internal tooth and a ring of DSK ratchet teeth on said dose set knob;
a driver including at least one external tooth and a ring of driver ratchet teeth on said driver;
a clicker operatively engaged between said dose set knob and said driver having at least a DSK ratchet arm for engaging said DSK ratchet teeth and at least a driver ratchet arm for engaging said driver ratchet teeth;
wherein said driver is prevented from rotating with said dose set knob while moving axially with said dose set knob during dose setting and dose correcting, and when said push button is depressed, said clicker is moved distally and pushes said driver distally such that said at least one external tooth of said driver engages said at least one internal tooth of said dose set knob thereby forcing said driver to rotate with said dose set knob during an injection.
Claim 2 of the cited patent discloses:
wherein said dose set knob rotating with respect to said clicker during dose setting generates a first audible indicia, and said driver rotating with respect to said clicker member during dose correction generates a second audible indicia.
Based on the above comments, all the structural limitations disclosed in claim 1 of this application are disclosed by claim 1 of the cited patent. Accordingly, a person of ordinary skill in the art would have concluded that although the claims at issue are not identical, they are not patentably distinct from each other.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 3, 8, 15, and 16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over DeRuntz et al. (US 7,291,132; hereinafter “DeRuntz”) in view of Veasey et al. (US 7,918,833; hereinafter “Veasey”).
Claim 1 recites a medication injection pen, comprising:
a housing;
a dose set knob that rotates with respect to the housing during dose setting and dose correcting;
a driver selectively engaged with the dose set knob, the driver rotatably fixed with respect to the housing during dose setting and dose correcting; and
a clicker operatively engaged between said dose set knob and said driver;
wherein the driver moves axially with the dose set knob during dose setting, dose correcting, and dose injecting, the dose set knob rotating with respect to the clicker during the dose setting generates a first audible indicia, and the clicker rotating with respect to the driver during the dose correcting generates a second audible indicia.
In relation to independent claim 1, DeRuntz discloses a medication injection pen having a housing and an internal drive mechanism. DeRuntz expressly discloses “housing 60” (col. 5, line 63) and “housing 360” (col. 15, line 64).
DeRuntz further discloses a driver that is rotatably fixed with respect to the housing during operation. DeRuntz states: “Tabs 80 prevent drive member 62 from rotating within housing 60” (col. 6, lines 23-24) and “permit drive member 62 to be shifted longitudinally” (col. 6, lines 24-25). DeRuntz also states that “Drive member 62 is in the form of a screw that is axially translatable and rotatably fixed during dosing and injecting” (col. 6, lines 48-49). Thus, DeRuntz discloses the following elements of claim 1: a medication injection pen; a housing; a driver; and the driver being rotatably fixed with respect to the housing, while also being axially movable.
DeRuntz also discloses a clicker-type arrangement associated with dose setting. DeRuntz states that “clicker members 98 cooperate with complimentary elements provided on the drive sleeve to provide a clicker function during dose setting” (col. 7, lines 54-56) and further states that the clicker function occurs “in either dose increasing or dose decreasing directions” (col. 17, line 1). Accordingly, DeRuntz additionally teaches: a clicker-related mechanism in the dose-setting train; and audible or tactile feedback during dose setting, including increasing and decreasing dose directions.
DeRuntz does not expressly disclose: a dose set knob that rotates with respect to the housing during dose setting and dose correcting in the manner claimed; a driver selectively engaged with the dose set knob; the specific relationship in which a clicker is operatively engaged between the dose set knob and the driver; and the more specific claim language that “the dose set knob rotating with respect to the clicker during the dose setting generates a first audible indicia,” and “the clicker rotating with respect to the driver during the dose correcting generates a second audible indicia.”
In other words, while DeRuntz teaches a rotatably fixed, axially translatable driver and clicker functionality, DeRuntz does not expressly disclose the full claimed interaction among the dose set knob, clicker, and driver, or the specific selective engagement arrangement recited in claim 1. However, Veasey discloses a rotatable dose-setting member corresponding to the claimed dose set knob. Veasey states: “a user rotates the dose dial grip 76.” (see figure 9; col. 5, lines 27-28)
Veasey also discloses dose correcting by reverse dialing. Veasey states that interacting teeth “create the clicks corresponding to dialed dose reduction.” (col. 5, starting in the last line of the column and ending in col. 6, line 1)
Veasey further discloses a selective engagement between the dose-setting structure and the drive structure. Veasey states: “clutch means are provided which upon depression of the button permit rotation between the dose dial sleeve and the drive sleeve” (claim 2, col. 6, lines 65-67). Veasey also states that “the clutch 60 is keyed to the drive sleeve 30.” (col. 4, line 36)
Veasey additionally discloses a clicker in the dose-setting mechanism. Veasey states: “Audible and tactile feedback is provided by the clicker 50 and the clutch means 60” (col. 5, lines 31-32). Veasey also states that “each click corresponds to a unit dose” (col. 5, lines 36-37). Thus, Veasey discloses the limitations missing from Friesen, namely: a dose set knob or dose dial grip that rotates during dose setting; dose correcting by reverse dialing; selective engagement between the dose-setting member and the drive member; a clicker operatively associated with those parts; and audible feedback during both dose setting and dose correction.
Based on the above comments, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the pen injector of DeRuntz with the dose-setting, clutch, and clicker features taught by Veasey in order to provide reliable dose setting and dose correction with audible user feedback, while retaining DeRuntz’s rotatably fixed, axially translatable driver arrangement. Both references are directed to pen-type medicament injection devices and both address the same general problem of controlled dose selection and delivery. The combination would have merely involved using Veasey’s known dose dial, clutch, and clicker arrangement with Friesen’s known driver architecture for its predictable result of improved dose-setting control and user feedback.
In relation to claim 2, as discussed above, DeRuntz discloses a driver arrangement used during dose delivery and states that the drive member is “axially translatable and rotatably fixed during dosing and injecting.” DeRuntz also explains that “Tabs 80 prevent drive member 62 from rotating within housing 60” while permitting longitudinal shifting. Thus, DeRuntz discloses a delivery mode in which the drive member or driver participates in the injection operation.
DeRuntz does not expressly disclose that, during dose injecting, “the driver rotates with the dose set knob” while “the clicker is rotationally fixed with respect to the driver and the dose set knob,” as specifically recited in claim 2. DeRuntz discusses dose and injecting states and clicker function, but does not clearly set out that exact rotational relationship among the knob, clicker, and driver during injection. However, Veasey discloses the operative rotational relationships during injection. Veasey states that, during dose dialing, “the drive sleeve 30, the clicker 50, the clutch means 60 and the dose dial sleeve 70 rotate with the dose dial grip 76.” Veasey also states that “upon depression of the button the clutch means permit rotation between the dose dial sleeve and the drive sleeve.” These teachings show the injection-state coupling and decoupling relationships among the dose-setting member, clicker, and drive structure.
Based on the above comments, it would have been obvious to modify DeRuntz’s injector with Veasey’s expressly described injection-state rotational relationships in order to define how the clicker and drive components behave during dose delivery and to provide predictable transmission of injection force in a pen-type injector. Both references address the same dose-setting and dose-delivery mechanics in medication injection pens.
In relation to claim 3, DeRuntz discloses a medication dispensing pen with a housing and an internal drive system for advancing a piston during dispensing. DeRuntz teaches a drive member and dose-delivery components in a cartridge-based pen system. DeRuntz does not expressly disclose, in the same terms as claim 3, “a piston rod rotatably fixed with respect to the housing during the dose setting, the dose correcting and the dose injecting.” While DeRuntz discloses anti-rotation for the drive member, it does not clearly identify the piston rod itself as the component rotatably fixed to the housing. However, Veasey discloses “a piston rod adapted to operate through the housing,” and explains that the dose dial sleeve and drive sleeve are arranged relative to the piston rod. Therefore, it would have been obvious to use Veasey’s piston-rod arrangement with Friesen’s housing-fixed drive architecture to provide a conventional non-rotating piston rod in a pen injector while allowing surrounding dose-setting parts to rotate during dose setting and correction. This would have been a predictable implementation of known injector mechanics.
In relation to claim 8, Veasey teaches the push button and the engagement function. Veasey states that “clutch means are provided” (col. 1, line 53) and that, “upon depression of the button” (col. 1, lines 53-54) rotation is permitted between the dose dial sleeve and the drive sleeve. This discloses button-actuated selective engagement or disengagement among the dose-setting and drive components. Therefore, since this enhancement was well-known in the art at the time of the invention, its implementation in the invention would have been considered an obvious alternative in the design of the injection pen.
In relation to claims 15 and 16, as discussed above, DeRuntz teaches the clicker function “during dose setting” and in “either dose increasing or dose decreasing directions,” reinforcing the setting-state relationship between clicker and drive components. Therefore, since this enhancement was well-known in the art at the time of the invention, its implementation in the invention would have been considered an obvious alternative in the design of the injection pen.
Claim 4 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over DeRuntz et al. (US 7,291,132; hereinafter “DeRuntz”) in view of Veasey et al. (US 7,918,833; hereinafter “Veasey”), as discussed above, and in further view of Knight et al. (US 7,771,398; hereinafter “Knight”).
In relation to claim 4, DeRuntz discloses a dose-setting member and a drive arrangement that advances medication-delivery structure during injection. DeRuntz teaches an axially translatable drive member used in the dose-delivery process. DeRuntz does not expressly disclose that “the dose set knob rotates to cause the piston rod to axially move with respect to the housing during the dose injecting,” in the precise form recited. However, Knight expressly teaches the rotational-to-axial conversion at the piston rod. It states that “rotation of the drive-shaft in either the clockwise or anti-clockwise direction drives the piston rod in distal direction” (col. 5, lines 7-9) and that the drive shaft has outer threading mating “corresponding internal threading on the piston rod” (col. 5, lines 4-5). This teaches the claimed relationship where rotational input causes axial piston-rod movement during injection. Therefore, it would have been obvious to incorporate the known threaded rotational-to-axial piston-rod drive of Knight into DeRuntz’s injector to achieve controlled piston advancement during dose delivery, because both references concern mechanical drive conversion in medication injection pens.
Claims 9 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over DeRuntz et al. (US 7,291,132; hereinafter “DeRuntz”) in view of Veasey et al. (US 7,918,833; hereinafter “Veasey”), as discussed above, and in further view of Burroughs et al. (US 6,221,046B1; hereinafter “Burroughs”).
In relation to claim 9, DeRuntz does not disclose “a lead screw rotatably fixed to the driver,” nor that “the driver moves axially with respect to the leadscrew during the dose setting and the dose correcting” in the exact form recited in claim 9. However, Burroughs discloses a leadscrew and nut arrangement in the dose-setting mechanism together with splined engagement relationships between the dial and nut or drive members (col. 2, lines 25-35). It therefore teaches the missing leadscrew-based structural relationship needed for claim 9. Therefore, since this enhancement was well-known in the art at the time of the invention, its implementation in the invention would have been considered an obvious alternative in the design of the injection pen.
Allowable Subject Matter
Claims 5 and 10 [and respective dependent claims 6, 7, 17 and claims 11-14] are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In relation to claim 5, none of the cited references of this office action discloses a brake tower that is rotatable and axially fixed to the housing of the injection pen.
In relation to claim 10, Burroughs is closest prior art. This reference discloses a leadscrew and nut arrangement; however, this reference alone or in combination with the other cited references, does not disclose or suggest the limitation: “the leadscrew is threadably engaged to the piston rod such that rotation of the leadscrew during the dose injecting causes the piston rod to move axially”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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