DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
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Claim(s) 1-16 rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 12, 13, and 14 of U.S. Patent No. 9,057,369. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claim 1, the reference patent (‘369) claims (see Clm. 1):
a device for administering a fluid product (Clm. 1), comprising:
a) a first casing part comprising a reservoir for the product (Clm. 1 – see a and b);
b) a second casing part connected to the first casing part (Clm. 1);
c) a piston rod for exerting a delivery movement in an advancing direction from the second casing part (Clm. 1);
d) a drive member configured as a sleeve with a thread formed by the sleeve of the drive member (Clm. 1), the drive member operable for moving the piston rod (Clm. 1), wherein the second casing part directly forms a linear guide that engages with the drive member in an engagement such that the drive member is linearly guided by the engagement during movement of the drive member relative to the second casing part in and against the advancing direction (Clm. 1)
e) a coupler comprising a coupler input member adapted to couple the drive member to the piston rod in a coupler engagement (Clm. 1), wherein the coupler input member is configured as a sleeve with a thread formed by the sleeve of the coupler input member (see Clm. 1), wherein the thread of the coupler input member is in a threaded engagement with the thread of the drive member such that the coupler input member transfers a drive force of the drive member onto the piston rod by the threaded engagement (Clm. 1); and
f) a dosing member for setting a product dosage deliverable by operating or triggering the drive member (Clm. 12), wherein the dosing member is coupled to the drive member such that a dosing movement of the dosing member results in a dosing movement of the drive member, wherein during dose setting the dosing member is rotationally secured to the coupler input member such that the coupler input member rotates with the dosing member (Clm. 12).
As such, Clm. 12 of the reference patent anticipates Clm. 1 of the instant application and is not patentably distinct.
Regarding Claim 10, the reference patent (‘369) claims:
a device for administering a fluid product (Clm. 1), comprising:
a) a first casing part a comprising a reservoir for the product (Clm. 1);
b) a second casing part connected to the first casing part (Clm. 1);
c) a drive member configured as a sleeve with a thread formed by the sleeve of the drive member, the drive member operable for use in a delivery operation, wherein a linear guide directly formed by the second casing part engages with the drive member such that the drive member is linearly guided during movement in and against an advancing direction (Clm. 1);
d) a coupler comprising a coupler input member adapted to couple the drive member in a coupler engagement during the delivery operation, wherein the coupler input member is configured as a sleeve with a thread formed by the sleeve of the coupler input member, wherein the thread of the coupler input member is in a threaded engagement with the thread of the drive member such that a drive force of the drive member is transferred to the coupler input member by the threaded engagement to cause a delivery movement (Clm. 1); and
e) a dosing member for setting a product dosage deliverable by operating or triggering the drive member, wherein the dosing member is coupled to the drive member such that a dosing movement of the dosing member results in a dosing movement of the drive member, wherein during dose setting the dosing member is rotationally secured to the coupler input member such that the coupler input member rotates with the dosing member (Clm. 12).
As such, Clm. 12 of the reference patent anticipates Clm. 10 of the instant application.
The dependent claims of the instant application either recite limitations explicitly found in Claims 1, 12, 13, or 14 OR recite such features which are only nominal in nature and do not provide any specific contribution over the claims of the issued patent, the limitations being obvious modifications or restatements as to the function of the claimed invention of the reference patent.
Regarding Claim 2, see Clm. 1
Regarding Claim 3, while no display is claimed, such hardware is notoriously well-known and obvious to include into the claimed apparatus in order to permit a user to visualize the set dose.
Regarding Claim 4, see Clm. 1
Regarding Claim 5, while no “optical” display is claimed, such hardware is notoriously well-known and obvious to include into the claimed apparatus in order to permit a user to visualize the set dose.
Regarding Claim 6, see Clm. 2 or 4
Regarding Claim 7, see Clm. 1
Regarding Claim 8, see Clm. 6
Regarding Claim 9, while the claims are not explicitly directed toward an “injection pen”, per se, such a species constitutes merely one implicitly defined species within the genus of “a device for administering a fluid product” which would be expected to have a dosing member, casing parts…etc.
Regarding Claim 11, an optical display constitutes an obvious addition to the claimed apparatus to permit a user to determine the set dose.
Regarding Claim 12, see Clm. 6
Regarding Claim 13, see Clm. 1
Regarding Claim 14, see Clm. 1
Regarding Claim 15, see Clm. 1 and 12
Regarding Claim 16, while the claims are not explicitly directed toward an “injection pen”, per se, such a species constitutes merely one implicitly defined species within the genus of “a device for administering a fluid product” which would be expected to have a dosing member, casing parts…etc.
Claim(s) 1-16 rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-8 of U.S. Patent No. 11,931,558. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claim 1, the reference patent (‘558) claims (see Clm. 1):
a device for administering a fluid product (Clm. 1), comprising:
a) a first casing part comprising a reservoir for the product (Clm. 1);
b) a second casing part connected to the first casing part (Clm. 1);
c) a piston rod for exerting a delivery movement in an advancing direction from the second casing part (Clm. 1);
d) a drive member configured as a sleeve with a thread formed by the sleeve of the drive member (Clm. 1), the drive member operable for moving the piston rod (Clm. 1), wherein the second casing part directly forms a linear guide that engages with the drive member in an engagement such that the drive member is linearly guided by the engagement during movement of the drive member relative to the second casing part in and against the advancing direction (Clm. 1)
e) a coupler comprising a coupler input member adapted to couple the drive member to the piston rod in a coupler engagement (Clm. 1), wherein the coupler input member is configured as a sleeve with a thread formed by the sleeve of the coupler input member (see Clm. 1), wherein the thread of the coupler input member is in a threaded engagement with the thread of the drive member such that the coupler input member transfers a drive force of the drive member onto the piston rod by the threaded engagement (Clm. 1); and
f) a dosing member for setting a product dosage deliverable by operating or triggering the drive member (Clm. 1), wherein the dosing member is coupled to the drive member such that a dosing movement of the dosing member results in a dosing movement of the drive member, wherein during dose setting the dosing member is rotationally secured to the coupler input member such that the coupler input member rotates with the dosing member (Clm. 1).
As such, Clm. 1 of the reference patent anticipates Clm. 1 of the instant application and is not patentably distinct.
Regarding Claim 10, the reference patent (‘558) claims:
a device for administering a fluid product (Clm. 1), comprising:
a) a first casing part a comprising a reservoir for the product (Clm. 1);
b) a second casing part connected to the first casing part (Clm. 1);
c) a drive member configured as a sleeve with a thread formed by the sleeve of the drive member, the drive member operable for use in a delivery operation, wherein a linear guide directly formed by the second casing part engages with the drive member such that the drive member is linearly guided during movement in and against an advancing direction (Clm. 1);
d) a coupler comprising a coupler input member adapted to couple the drive member in a coupler engagement during the delivery operation, wherein the coupler input member is configured as a sleeve with a thread formed by the sleeve of the coupler input member, wherein the thread of the coupler input member is in a threaded engagement with the thread of the drive member such that a drive force of the drive member is transferred to the coupler input member by the threaded engagement to cause a delivery movement (Clm. 1); and
e) a dosing member for setting a product dosage deliverable by operating or triggering the drive member, wherein the dosing member is coupled to the drive member such that a dosing movement of the dosing member results in a dosing movement of the drive member, wherein during dose setting the dosing member is rotationally secured to the coupler input member such that the coupler input member rotates with the dosing member (Clm. 1).
As such, Clm. 1 of the reference patent anticipates Clm. 10 of the instant application.
The dependent claims of the instant application either recite limitations explicitly found in Claims 1-8 OR recite such features which are only nominal in nature and do not provide any specific contribution over the claims of the issued patent, the limitations being obvious modifications or restatements as to the function of the claimed invention of the reference patent.
Regarding Claim 2, see Clm. 3
Regarding Claim 3, see Clm. 1
Regarding Claim 4, see Clm. 1
Regarding Claim 5, see Clm. 2
Regarding Claim 6, see Clm. 4
Regarding Claim 7, see Clm. 6
Regarding Claim 8, see Clm. 7
Regarding Claim 9, see Clm. 8
Regarding Claim 11, see Clm. 2
Regarding Claim 12, see Clm. 4
Regarding Claim 13, see Clm. 5
Regarding Claim 14, see Clm. 6
Regarding Claim 15, see Clm. 7
Regarding Claim 16, see Clm. 8
Claim(s) 1-16 rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-18 of U.S. Patent No. 12,678,568. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claim 1, the reference patent (‘568) claims (see Clm. 1 or 12):
a device for administering a fluid product (Clm. 1 or 12), comprising:
a) a first casing part comprising a reservoir for the product (Clm. 1 or 12);
b) a second casing part connected to the first casing part (Clm. 1 or 12);
c) a piston rod for exerting a delivery movement in an advancing direction from the second casing part (Clm. 1 or 12);
d) a drive member configured as a sleeve with a thread formed by the sleeve of the drive member (Clm. 1 or 12), the drive member operable for moving the piston rod (Clm. 1 or 12), wherein the second casing part directly forms a linear guide that engages with the drive member in an engagement such that the drive member is linearly guided by the engagement during movement of the drive member relative to the second casing part in and against the advancing direction (Clm. 1 or 12)
e) a coupler comprising a coupler input member adapted to couple the drive member to the piston rod in a coupler engagement (Clm. 1 or 12), wherein the coupler input member is configured as a sleeve with a thread formed by the sleeve of the coupler input member (see Clm. 1 or 12), wherein the thread of the coupler input member is in a threaded engagement with the thread of the drive member such that the coupler input member transfers a drive force of the drive member onto the piston rod by the threaded engagement (Clm. 1 or 12); and
f) a dosing member for setting a product dosage deliverable by operating or triggering the drive member (Clm. 1 or 12), wherein the dosing member is coupled to the drive member such that a dosing movement of the dosing member results in a dosing movement of the drive member, wherein during dose setting the dosing member is rotationally secured to the coupler input member such that the coupler input member rotates with the dosing member (Clm. 1 or 12).
As such, Clms. 1 or 12 of the reference patent anticipates Clm. 1 of the instant application and is not patentably distinct.
Regarding Claim 10, the reference patent (‘568) claims:
a device for administering a fluid product (Clm. 1 or 12), comprising:
a) a first casing part a comprising a reservoir for the product (Clm. 1 or 12);
b) a second casing part connected to the first casing part (Clm. 1 or 12);
c) a drive member configured as a sleeve with a thread formed by the sleeve of the drive member, the drive member operable for use in a delivery operation, wherein a linear guide directly formed by the second casing part engages with the drive member such that the drive member is linearly guided during movement in and against an advancing direction (Clm. 1 or 12);
d) a coupler comprising a coupler input member adapted to couple the drive member in a coupler engagement during the delivery operation, wherein the coupler input member is configured as a sleeve with a thread formed by the sleeve of the coupler input member, wherein the thread of the coupler input member is in a threaded engagement with the thread of the drive member such that a drive force of the drive member is transferred to the coupler input member by the threaded engagement to cause a delivery movement (Clm. 1 or 12); and
e) a dosing member for setting a product dosage deliverable by operating or triggering the drive member, wherein the dosing member is coupled to the drive member such that a dosing movement of the dosing member results in a dosing movement of the drive member, wherein during dose setting the dosing member is rotationally secured to the coupler input member such that the coupler input member rotates with the dosing member (Clm. 1 or 12).
As such, Clm. 1 or 12 of the reference patent anticipates Clm. 10 of the instant application.
The dependent claims of the instant application either recite limitations explicitly found in Claims 1-18 OR recite such features which are only nominal in nature and do not provide any specific contribution over the claims of the issued patent, the limitations being obvious modifications or restatements as to the function of the claimed invention of the reference patent.
Regarding Claim 2, see Clm. 1 or 12
Regarding Claim 3, see Clm. 10 or 18
Regarding Claim 4, see Clm. 1 or 12
Regarding Claim 5, see Clm. 11
Regarding Claim 6, see Clm. 8 or 17
Regarding Claim 7, see Clm. 1 or 12
Regarding Claim 8, see Clm. 12
Regarding Claim 9, while the claims are not explicitly directed toward an “injection pen”, per se, such a species constitutes merely one implicitly defined species within the genus of “a device for administering a fluid product” which would be expected to have a piston rod, dosing member…etc.
Regarding Claim 11, see Clm. 11.
Regarding Claim 12, see Clm. 8 or 17.
Regarding Claim 13, see Clm. 1 or 12
Regarding Claim 14, see Clm. 1 or 12
Regarding Claim 15, see Clm. 12
Regarding Claim 16, while the claims are not explicitly directed toward an “injection pen”, per se, such a species constitutes merely one implicitly defined species within the genus of “a device for administering a fluid product” which would be expected to have a dosing member, casing parts…etc.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 08/25/2026
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