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(s) 60 – 67 and 72 – 82 are objected to because of the following informalities:
Claims 60 – 67 and 72 – 82 each recite the preamble “A medicament injector according to.” Claims 60 – 67 and 72 – 82 are objected because the preamble includes improper antecedent basis for the independent Claim 59. The Examiner suggests amending each preamble to recite “[[A]] The medicament injector according to” in order to provide proper antecedent basis.
Claim 65 recites “said seating areas.” The Examiner objects to this claim limitation because it does not include the same nomenclature as previously recited within Claim 65 when referring to this structure. The Examiner suggests amending this to recite “said plurality of seating areas.”
Claim 66 recites “wherein said plurality of sealing elements is configured to engage.” The Examiner suggests amending the word “is” to recite “are” in order to correct the grammar of the claim language.
Claim 76 recites “wherein vacuum is created.” The Examiner suggests amending this to recite “wherein the vacuum is created” to provide proper antecedent basis for the claim language and to refer to the vacuum recited in the claims upon which Claim 76 depends.
Claims 77 recites “wherein vacuum is created.” The Examiner suggests amending this to recite “wherein a vacuum is created” to provide proper antecedent basis for this claim limitation in the claim.
Claims 78 recites “wherein vacuum is created.” The Examiner suggests amending this to recite “wherein a vacuum is created” to provide proper antecedent basis for this claim limitation in the claim.
Claims 79 recites “wherein vacuum is created.” The Examiner suggests amending this to recite “wherein a vacuum is created” to provide proper antecedent basis for this claim limitation in the claim.
Appropriate correction is required.
Claim Interpretation
The claim language of “user-powered automatic injection assembly” is interpreted to be an automatic injection assembly that is initiated via the user actuating a control feature. After actuating the control feature, the assembly automatically injects the medicament into the subject. This interpretation is consistent with the third full paragraph of page 7 of the Specification dated 8 September 2023.
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.
Claim(s) 63, 64, 66, 67, 73, 74, and 79 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 63 recites “said end cover” and “said rearward motion.” There is insufficient antecedent basis for these limitations in the claim. Therefore, Claim 63 is rejected as being indefinite.
Claim 79 is dependent upon Claim 63 and is therefore rejected under 35 U.S.C. § 112(b) for the same rationale as Claim 63.
Claim 64 recites “vacuum” and “said end cover.” There is insufficient antecedent basis for these limitations in the claim. Therefore, Claim 64 is rejected as being indefinite.
Claim 66 recites “said rearward motion.” There is insufficient antecedent basis for this limitation in the claim. Therefore, Claim 66 is rejected as being indefinite.
Claim 67 recites “said partial vacuum.” There is insufficient antecedent basis for this limitation in the claim. Therefore, Claim 67 is rejected as being indefinite.
Claim 73 recites “said end cover” and “said rearward motion.” There is insufficient antecedent basis for these limitations in the claim. Therefore, Claim 73 is rejected as being indefinite.
Claim 74 recites “said rearward motion.” There is insufficient antecedent basis for this limitation in the claim. Therefore, Claim 74 is rejected as being indefinite.
Claim 79 recites “said end cover.” There is insufficient antecedent basis for this limitation in the claim. Therefore, Claim 79 is rejected as being indefinite.
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.
Claim(s) 59 – 61, 64, 72, 76, and 77 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kipfer et al. (US 6,368,314 B1; hereinafter referred to as “Kipfer”).
With regards to claim 59, Kipfer discloses a medicament injector (see Col. 5, lines 11 – 15 “a portable infusion pump”) comprising:
a reusable, user-powered automatic injection assembly (see Col. 9, lines 24 – 39 “switching on of the device after an ampulla exchange” and see Fig. 1 where the reusable-user powered automatic injection assembly is everything besides the ampulla 2) including a medicament injection subassembly (7, 10, 10a, 10b) (see Col. 5, lines 16 – 25 and Col. 6, lines 6 – 39); and
a medicament module (2) (see Col. 5, lines 16 – 25) removably insertable into said reusable, user-powered automatic injection assembly (see Col. 9, lines 24 – 39 “an ampulla exchange”);
said medicament injection subassembly including a plurality of sealing elements (10b) (see Col. 6, lines 12 – 39 “elastic supporting elements 10b in the form of a pair of O-rings, for example, rubber rings”) and a sealing element seating assembly (see Col. 6, lines 12 – 39 “The O-rings are received in circumferential grooves of the platform sleeve 10a and in this manner fixed relative to the two opposite surfaces of the housing and the platform sleeve 10a by form fit and force fit” where the circumferential grooves of the platform sleeve 10a are the sealing element seating assembly) which provides for varying damping of forward motion of said medicament injection subassembly along a longitudinal axis (V) (see Col. 6, lines 40 – 48 “the axis of displacement V”) (the claim language “a plurality of sealing element and a sealing element seating assembly which provides for varying damping of forward motion of said medicament injection subassembly along a longitudinal axis” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2173.05(g). The claim is an apparatus claim and is to be limited by structural limitations. MPEP 2114. The Office submits that the medicament injector of Kipfer meets the structural limitations of the claim and is capable of varying damping of forward motion of said medicament injection subassembly along a longitudinal axis because the sealing elements 10b are made of materials that vary damping of forward motion. See Col. 6, lines 12 – 39 where the O-rings are described as being made of rubber.)
With regards to claim 60, Kipfer discloses the claimed invention of Claim 59, and Kipfer further discloses wherein said plurality of sealing elements (10b) (see Col. 6, lines 12 – 39) and said sealing element seating assembly (see Col. 6, lines 12 – 39 “where the circumferential grooves of the platform sleeve 10a are the sealing element seating assembly) are configured to provide vacuum damping of said forward motion of said medicament injection subassembly (7, 10, 10a, 10b) (see Col. 5, lines 16 – 25 and Col. 6, lines 6 – 39) along said longitudinal axis (V) (see Col. 6, lines 40 – 48) (the claim language of “said plurality of sealing elements and said sealing element seating assembly are configured to provide vacuum damping of said forward motion of said medicament injection subassembly along said longitudinal axis” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2173.05(g). Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. MPEP 2114. The Office submits that the device of Kipfer meets the structural limitations of the claim and is capable of providing vacuum damping of said forward motion of said medicament injection subassembly along said longitudinal axis. The device of Kipfer is capable of providing vacuum damping of the forward motion because a vacuum is formed during the elastic deformation of the O-rings. The elastic deformation is described within Col. 6, lines 12 – 39 of Kipfer).
With regards to claim 61, Kipfer discloses the claimed invention of Claim 59, and Kipfer further discloses wherein said reusable, user-powered automatic injection assembly (see Col. 9, lines 24 – 39 “switching on of the device after an ampulla exchange” and see Fig. 1 where the reusable-user powered automatic injection assembly is everything besides the ampulla 2) also includes an end cover (1) (see Col. 5, lines 16 – 25 “a pump housing 1”) and said sealing element seating assembly (see Col. 6, lines 12 – 39 “where the circumferential grooves of the platform sleeve 10a are the sealing element seating assembly) with said plurality of sealing elements (10b) (see Col. 6, lines 12 – 39) mounted thereon is operatively and frictionally engaged with said end cover (see Fig. 1 and Col. 6, lines 6 – 39 “The moveable platform 10 is therefor longitudinally moveably supported with a platform sleeve 10a in a housing sleeve part surrounding this sleeve 10a, by way of elastic supporting elements 10b in the form of a pair of O-rings, for example, rubber rings…A contact between the moveable platform and the housing 1 is only created through these O-rings 10b.”).
With regards to claim 64, Kipfer discloses the claimed invention of Claim 59, and Kipfer further discloses wherein vacuum is created between said end cover (1) (see Col. 5, lines 16 – 25 “a pump housing 1”) and said plurality of sealing elements (10b) (see Col. 6, lines 12 – 39) during said forward motion (here a vacuum is created between the end cover and the plurality of sealing elements during the forward motion because of the elastic deformation of the O-rings. The elastic deformation is described within Col. 6, lines 12 – 39 of Kipfer).
With regards to claim 72, Kipfer discloses the claimed invention of Claim 60, and Kipfer further discloses wherein said reusable, user-powered automatic injection assembly (see Col. 9, lines 24 – 39 “switching on of the device after an ampulla exchange” and see Fig. 1 where the reusable-user powered automatic injection assembly is everything besides the ampulla 2) also includes an end cover (1) (see Col. 5, lines 16 – 25 “a pump housing 1”) and said sealing element seating assembly (see Col. 6, lines 12 – 39 “where the circumferential grooves of the platform sleeve 10a are the sealing element seating assembly) with said plurality of sealing elements (10b) (see Col. 6, lines 12 – 39) mounted thereon is operatively and frictionally engaged with said end cover (see Fig. 1 and Col. 6, lines 6 – 39 “The moveable platform 10 is therefor longitudinally moveably supported with a platform sleeve 10a in a housing sleeve part surrounding this sleeve 10a, by way of elastic supporting elements 10b in the form of a pair of O-rings, for example, rubber rings…A contact between the moveable platform and the housing 1 is only created through these O-rings 10b.”).
With regards to claim 76, Kipfer discloses the claimed invention of Claim 60, and Kipfer further discloses wherein vacuum is created between said end cover (1) (see Col. 5, lines 16 – 25 “a pump housing 1”) and said plurality of sealing elements (10b) (see Col. 6, lines 12 – 39) during said forward motion (here a vacuum is created between the end cover and the plurality of sealing elements during the forward motion because of the elastic deformation of the O-rings. The elastic deformation is described within Col. 6, lines 12 – 39 of Kipfer).
With regards to claim 77, Kipfer discloses the claimed invention of Claim 61, and Kipfer further discloses wherein vacuum is created between said end cover (1) (see Col. 5, lines 16 – 25 “a pump housing 1”) and said plurality of sealing elements (10b) (see Col. 6, lines 12 – 39) during said forward motion (here a vacuum is created between the end cover and the plurality of sealing elements during the forward motion because of the elastic deformation of the O-rings. The elastic deformation is described within Col. 6, lines 12 – 39 of Kipfer).
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(s) 63, 73, 74, and 79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kipfer in view of Shill (US 3,724,973 A)
With regards to claim 63, Kipfer discloses the claimed invention of Claim 59, however, Kipfer is silent with regards to wherein at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion.
Nonetheless Shill, which is within the analogous art of surgical pumps (see abstract and title), teaches at least one slot (see Col. 5, lines 13 – 20 “A vent (illustrated by dotted lines) between the upper end of bore 65 and atmosphere permits escape of air trapped between the O-rings 71 and 73”) is formed in said sealing element seating assembly (see at 71 and 73 in Fig. 2) in order to provide air passage of air trapped between said end cover (60) and said plurality of sealing elements (71, 73) during said rearward motion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the sealing element seating assembly of the medicament injector of Kipfer in view of a teaching of Shill such that at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion. One of ordinary skill in the art would have been motivated to make this modification because Shill teaches that the slot permits an escape of air trapped between the O-rings (see Col. 5, lines 13 – 20). This release of air is beneficial because it ensures that the medicament injector operates smoothly and efficiently, preventing operational failures and protecting the device from damage. For example, bleeding or venting air helps maintain the stability of hydraulic systems preventing issues like jerky actuator movement and inconsistent cycle times.
The medicament injector of Kipfer modified in view of Shill will hereinafter be referred to as the medicament injector of Kipfer and Shill.
With regards to claim 73, Kipfer discloses the claimed invention of Claim 60, however, Kipfer is silent with regards to wherein at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion.
Nonetheless Shill, which is within the analogous art of surgical pumps (see abstract and title), teaches at least one slot (see Col. 5, lines 13 – 20 “A vent (illustrated by dotted lines) between the upper end of bore 65 and atmosphere permits escape of air trapped between the O-rings 71 and 73”) is formed in said sealing element seating assembly (see at 71 and 73 in Fig. 2) in order to provide air passage of air trapped between said end cover (60) and said plurality of sealing elements (71, 73) during said rearward motion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the sealing element seating assembly of the medicament injector of Kipfer in view of a teaching of Shill such that at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion. One of ordinary skill in the art would have been motivated to make this modification because Shill teaches that the slot permits an escape of air trapped between the O-rings (see Col. 5, lines 13 – 20). This release of air is beneficial because it ensures that the medicament injector operates smoothly and efficiently, preventing operational failures and protecting the device from damage. For example, bleeding or venting air helps maintain the stability of hydraulic systems preventing issues like jerky actuator movement and inconsistent cycle times.
With regards to claim 74, Kipfer discloses the claimed invention of Claim 61, however, Kipfer is silent with regards to wherein at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion.
Nonetheless Shill, which is within the analogous art of surgical pumps (see abstract and title), teaches at least one slot (see Col. 5, lines 13 – 20 “A vent (illustrated by dotted lines) between the upper end of bore 65 and atmosphere permits escape of air trapped between the O-rings 71 and 73”) is formed in said sealing element seating assembly (see at 71 and 73 in Fig. 2) in order to provide air passage of air trapped between said end cover (60) and said plurality of sealing elements (71, 73) during said rearward motion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the sealing element seating assembly of the medicament injector of Kipfer in view of a teaching of Shill such that at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion. One of ordinary skill in the art would have been motivated to make this modification because Shill teaches that the slot permits an escape of air trapped between the O-rings (see Col. 5, lines 13 – 20). This release of air is beneficial because it ensures that the medicament injector operates smoothly and efficiently, preventing operational failures and protecting the device from damage. For example, bleeding or venting air helps maintain the stability of hydraulic systems preventing issues like jerky actuator movement and inconsistent cycle times.
With regards to claim 79, the medicament injector of Kipfer and Shill teaches the claimed invention of claim 63, and Kipfer further teaches wherein vacuum is created between said end cover (1) (see Col. 5, lines 16 – 25 “a pump housing 1”) and said plurality of sealing elements (10b) (see Col. 6, lines 12 – 39) during said forward motion (here a vacuum is created between the end cover and the plurality of sealing elements during the forward motion because of the elastic deformation of the O-rings. The elastic deformation is described within Col. 6, lines 12 – 39 of Kipfer).
Claim(s) 62, 65 – 67, 78, and 80 – 82 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kipfer in view of Helmer et al. (US 2015/0302778 A1; hereinafter referred to as “Helmer”).
With regards to claim 62, Kipfer discloses the claimed invention of claim 61, however, Kipfer is silent with regards to wherein when said sealing element seating assembly is in rearward motion, said frictional engagement with said end cover is decreased and when said sealing element seating assembly is in forward motion, said frictional engagement with said end cover is increased.
Nonetheless Helmer, which is within the analogous art of drug delivery devices (see abstract and title)¸ teaches wherein when said sealing element seating assembly (12) (see [0041]) is in rearward motion (26) (see [0041] and Fig. 2), said frictional engagement with said end cover (36) (see [0042]) is decreased (see [0043] “At least it experiences a reduced radially outwardly directed pressure and therefore exerts correspondingly reduced dynamic friction towards the inside wall 36.”) and when said sealing element seating assembly is in forward motion (24) (see [0041] and Fig. 1), said frictional engagement with said end cover is increased (see [0042] “Consequently, when the piston 10 is displaced in distal direction 24, a comparatively large friction force between the ring 14 and the inside wall 36 of the body 32 is generated.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the sealing element seating assembly of Kipfer in view of a teaching of Helmer such that when said sealing element seating assembly is in rearward motion, said frictional engagement with said end cover is decreased and when said sealing element seating assembly is in forward motion, said frictional engagement with said end cover is increased. One of ordinary skill in the art would have been motivated to make this modification because Helmer teaches that this shape of the sealing element seating assembly generates a large friction force or reduced friction force between the O-rings and the end cover depending on which direction the movement is occurring (see [0042] and [0043] of Helmer). This would be advantageous because doing so creates a medicament injector that requires a smaller actuation force to displace the piston in the rearward direction than the force required to move the piston in the forward direction thereby allowing the injector conserve energy when reused.
The medicament injector of Kipfer modified in view of Helmer will hereinafter be referred to as the medicament injector of Kipfer and Helmer.
With regards to claim 65, Kipfer discloses the claimed invention of claim 59, and Kipfer further discloses wherein said sealing element seating assembly includes a plurality of seating areas at a rearward end thereof (see Col. 6, lines 12 – 39 “The O-rings are received in circumferential grooves of the platform sleeve 10a and in this manner fixed relative to the two opposite surfaces of the housing and the platform sleeve 10a by form fit and force fit” where the circumferential grooves of the platform sleeve 10a are the sealing element seating assembly shown in Fig. 1).
However Kipfer is silent with regards to said seating areas each include a planar surface and a tapered surface.
Nonetheless Helmer, which is within the analogous art of drug delivery devices (see abstract and title)¸ teaches said seating areas each include a planar surface (18) (see [0041]) and a tapered surface (22) (see [0041] and Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shape of each seating area of the medicament injector of Kipfer in view of a teaching of Helmer such that said seating areas each include a planar surface and a tapered surface. One of ordinary skill in the art would have been motivated to make this modification because Helmer teaches that this shape of the sealing element seating assembly generates a large friction force or reduced friction force between the O-rings and the end cover depending on which direction the movement is occurring (see [0042] and [0043] of Helmer). This would be advantageous because doing so creates a medicament injector that requires a smaller actuation force to displace the piston in the rearward direction than the force required to move the piston in the forward direction thereby allowing the injector conserve energy when reused.
The medicament injector of Kipfer modified in view of Helmer will hereinafter be referred to as the medicament injector of Kipfer and Helmer.
With regards to claim 66, the medicament injector of Kipfer and Helmer teaches the claimed invention of claim 65, and the medicament injector of Kipfer and Helmer teaches wherein said plurality of sealing elements is configured to engage said planar surfaces during said rearward motion and is further configured to engage said tapered surfaces during said forward motion (the language of “said plurality of sealing elements is configured to engage said planar surfaces during said rearward motion and is further configured to engage said tapered surfaces during said forward motion” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2173.05(g). Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. MPEP 2114. The Office submits that the medicament injector of Kipfer and Helmer meets the structural limitations of the claim wherein the said plurality of sealing elements is configured to engage said planar surfaces during said rearward motion and is further configured to engage said tapered surfaces during said forward motion based on paragraphs [0041] and [0042] and Figures 1 – 2 of Helmer).
With regards to claim 67, the medicament injector of Kipfer and Helmer teaches the claimed invention of claim 62, and the medicament injector of Kipfer and Helmer further teaches wherein said greater friction engagement and said partial vacuum are configured for preventing damage to at least part of said medicament injector during said forward motion of said sealing element seating assembly (the language “wherein said greater friction engagement and said partial vacuum are configured for preventing damage to at least part of said medicament injector during said forward motion of said sealing element seating assembly” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2173.05(g). Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. MPEP 2114. The Office submits that the medicament injector of Kipfer and Helmer meets the structural limitations of the claim, and is capable of preventing damage to at least part of the medicament injector during forward motion of the sealing element seating assembly because the partial vacuum created by the O-ring and sealing element seating assembly during forward motion see Col. 6, lines 12 – 39 of Kipfer provides damping.).
With regards to claim 78, the medicament injector of Kipfer and Helmer teaches the claimed invention of claim 62, and Kipfer further teaches wherein vacuum is created between said end cover (1) (see Col. 5, lines 16 – 25 “a pump housing 1”) and said plurality of sealing elements (10b) (see Col. 6, lines 12 – 39) during said forward motion (here a vacuum is created between the end cover and the plurality of sealing elements during the forward motion because of the elastic deformation of the O-rings. The elastic deformation is described within Col. 6, lines 12 – 39 of Kipfer).
With regards to claim 80, Kipfer discloses the claimed invention of claim 60, and Kipfer further discloses wherein said sealing element seating assembly includes a plurality of seating areas at a rearward end thereof (see Col. 6, lines 12 – 39 “The O-rings are received in circumferential grooves of the platform sleeve 10a and in this manner fixed relative to the two opposite surfaces of the housing and the platform sleeve 10a by form fit and force fit” where the circumferential grooves of the platform sleeve 10a are the sealing element seating assembly shown in Fig. 1).
However Kipfer is silent with regards to said seating areas each include a planar surface and a tapered surface.
Nonetheless Helmer, which is within the analogous art of drug delivery devices (see abstract and title)¸ teaches said seating areas each include a planar surface (18) (see [0041]) and a tapered surface (22) (see [0041] and Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shape of each seating area of the medicament injector of Kipfer in view of a teaching of Helmer such that said seating areas each include a planar surface and a tapered surface. One of ordinary skill in the art would have been motivated to make this modification because Helmer teaches that this shape of the sealing element seating assembly generates a large friction force or reduced friction force between the O-rings and the end cover depending on which direction the movement is occurring (see [0042] and [0043] of Helmer). This would be advantageous because doing so creates a medicament injector that requires a smaller actuation force to displace the piston in the rearward direction than the force required to move the piston in the forward direction thereby allowing the injector conserve energy when reused.
With regards to claim 81, Kipfer discloses the claimed invention of claim 61, and Kipfer further discloses wherein said sealing element seating assembly includes a plurality of seating areas at a rearward end thereof (see Col. 6, lines 12 – 39 “The O-rings are received in circumferential grooves of the platform sleeve 10a and in this manner fixed relative to the two opposite surfaces of the housing and the platform sleeve 10a by form fit and force fit” where the circumferential grooves of the platform sleeve 10a are the sealing element seating assembly shown in Fig. 1).
However Kipfer is silent with regards to said seating areas each include a planar surface and a tapered surface.
Nonetheless Helmer, which is within the analogous art of drug delivery devices (see abstract and title)¸ teaches said seating areas each include a planar surface (18) (see [0041]) and a tapered surface (22) (see [0041] and Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shape of each seating area of the medicament injector of Kipfer in view of a teaching of Helmer such that said seating areas each include a planar surface and a tapered surface. One of ordinary skill in the art would have been motivated to make this modification because Helmer teaches that this shape of the sealing element seating assembly generates a large friction force or reduced friction force between the O-rings and the end cover depending on which direction the movement is occurring (see [0042] and [0043] of Helmer). This would be advantageous because doing so creates a medicament injector that requires a smaller actuation force to displace the piston in the rearward direction than the force required to move the piston in the forward direction thereby allowing the injector conserve energy when reused.
With regards to claim 82, the medicament injector of Kipfer and Helmer teaches the claimed invention of claim 62, and Kipfer further discloses wherein said sealing element seating assembly includes a plurality of seating areas at a rearward end thereof (see Col. 6, lines 12 – 39 “The O-rings are received in circumferential grooves of the platform sleeve 10a and in this manner fixed relative to the two opposite surfaces of the housing and the platform sleeve 10a by form fit and force fit” where the circumferential grooves of the platform sleeve 10a are the sealing element seating assembly shown in Fig. 1).
However Kipfer is silent with regards to said seating areas each include a planar surface and a tapered surface.
Nonetheless Helmer, which is within the analogous art of drug delivery devices (see abstract and title)¸ teaches said seating areas each include a planar surface (18) (see [0041]) and a tapered surface (22) (see [0041] and Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shape of each seating area of the medicament injector of Kipfer in view of a teaching of Helmer such that said seating areas each include a planar surface and a tapered surface. One of ordinary skill in the art would have been motivated to make this modification because Helmer teaches that this shape of the sealing element seating assembly generates a large friction force or reduced friction force between the O-rings and the end cover depending on which direction the movement is occurring (see [0042] and [0043] of Helmer). This would be advantageous because doing so creates a medicament injector that requires a smaller actuation force to displace the piston in the rearward direction than the force required to move the piston in the forward direction thereby allowing the injector conserve energy when reused.
Claim(s) 75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kipfer and Helmer as applied to claim 62 above, and further in view of Shill.
With regards to claim 75, the medicament injector of Kipfer and Helmer teaches the claimed invention of claim 62, however, Kipfer is silent with regards to wherein at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion.
Nonetheless Shill, which is within the analogous art of surgical pumps (see abstract and title), teaches at least one slot (see Col. 5, lines 13 – 20 “A vent (illustrated by dotted lines) between the upper end of bore 65 and atmosphere permits escape of air trapped between the O-rings 71 and 73”) is formed in said sealing element seating assembly (see at 71 and 73 in Fig. 2) in order to provide air passage of air trapped between said end cover (60) and said plurality of sealing elements (71, 73) during said rearward motion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the sealing element seating assembly of the medicament injector of Kipfer and Helmer in view of a teaching of Shill such that at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion. One of ordinary skill in the art would have been motivated to make this modification because Shill teaches that the slot permits an escape of air trapped between the O-rings (see Col. 5, lines 13 – 20). This release of air is beneficial because it ensures that the medicament injector operates smoothly and efficiently, preventing operational failures and protecting the device from damage. For example, bleeding or venting air helps maintain the stability of hydraulic systems preventing issues like jerky actuator movement and inconsistent cycle times.
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.
Claim(s) 59 – 67, 72 – 74, and 76 – 79 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 8 of U.S. Patent No. 11,786,658 B2 (hereinafter referred to as “Patent ’658”) in view of Kipfer.
With regards to claim 59, Claim 1 Patent ’658 recites of a medicament injector (see Col. 61, line 31) comprising:
a reusable, user-powered automatic injection assembly including a medicament injection subassembly (see Col. 61, lines 31 – 32 of Patent ’658); and
a medicament module removably insertable into said reusable, user-powered automatic injection assembly (see Col. 61, lines 33 – 34 of Patent ’658);
said medicament injection subassembly including a sealing element and a sealing element seating assembly which provides for varying damping of forward motion of said medicament injection subassembly along a longitudinal axis (see Col. 61, line 35 – 41 of Patent ’658) .
However, Patent ’658 is silent with regards to the sealing element being a plurality of sealing elements.
Nonetheless Kipfer, which is within the analogous art of medical devices (see abstract and title), teaches the sealing element being a plurality of sealing elements (10b) (see Col. 6, lines 12 – 39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the number of sealing elements of the medicament injector of Patent ’658 in view of a teaching of Kipfer such that the sealing element is a plurality of sealing elements. Additionally, the sealing element seating assembly is modified to have a plurality of seating areas at a rearward end in order to accommodate the plurality of sealing elements (see Col. 6, lines 12 – 39 of Kipfer). One of ordinary skill in the art would have been motivated to make this modification because multiple sealing elements provides redundancy and reliability where if one seal fails due to wear, damage, or environmental stress than the other seals can still maintain the seal.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the number of sealing elements such that there are a plurality of sealing elements, since it has been held that the mere duplication of parts has no patentable significance unless a new unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960); MPEP 2144.04(VI)(B).
The medicament injector of Patent ’658 modified in view of a teaching of Kipfer will hereinafter be referred to as the medicament injector of Patent ’658 and Kipfer.
With regards to claim 60, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 59, and Claim 4 of Patent ’658 further recites wherein said plurality of sealing elements and said sealing element seating assembly are configured to provide vacuum damping of said forward motion of said medicament injection subassembly along said longitudinal axis (see Col. 51, lines 51 – 55 of Patent ’658).
With regards to claim 61, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 59, and Claims 4 and 5 of Patent ’658 further recites wherein said reusable, user-powered automatic injection assembly also includes an end cover and said sealing element seating assembly with said plurality of sealing elements mounted thereon is operatively and frictionally engaged with said end cover (see Col. 61, lines 51 – 61 of Patent ’658).
With regards to claim 62, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 61, and Claim 6 of Patent ’658 further recites wherein when said sealing element seating assembly is in rearward motion, said frictional engagement with said end cover is decreased and when said sealing element seating assembly is in forward motion, said frictional engagement with said end cover is increased (see Col. 61, lines 62 – 67 of Patent ’658).
With regards to claim 63, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 59, and Claims 4, 5, and 7 of Patent ’658 further recites wherein at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion (see Col. 61, lines 51 – 61 and Col. 62, lines 1 – 5 of Patent ’658).
With regards to claim 64, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 59, and Claims 4, 5, and 8 of Patent ’658 further recites wherein vacuum is created between said end cover and said plurality of sealing elements during said forward motion (see Col. 61, lines 51 – 61 and Col. 62, lines 6 – 9 of Patent ’658).
With regards to claim 65, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 59, and Claim 2 of Patent ’658 further recites wherein said sealing element seating assembly includes a plurality of seating areas at a rearward end thereof, said seating areas each include a planar surface and a tapered surface (see Col. 61, lines 42 – 45 of Patent ’658).
With regards to claim 66, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 65, and Claim 3 of Patent ’658 further recites wherein said plurality of sealing elements is configured to engage said planar surfaces during said rearward motion and is further configured to engage said tapered surfaces during said forward motion (see Col. 61, lines 46 – 50 of Patent ’658).
With regards to claim 67, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 62, and the medicament injector of Patent ’658 and Kipfer further teaches with regards to wherein said greater friction engagement and said partial vacuum are configured for preventing damage to at least part of said medicament injector during said forward motion of said sealing element seating assembly (the language “wherein said greater friction engagement and said partial vacuum are configured for preventing damage to at least part of said medicament injector during said forward motion of said sealing element seating assembly” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2173.05(g). Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. MPEP 2114. The Office submits that the medicament injector of Patent ’658 and Kipfer meets the structural limitations of the claim, and is capable of preventing damage to at least part of the medicament injector during forward motion of the sealing element seating assembly because the partial vacuum created by the O-ring and sealing element seating assembly during forward motion see Claims 1, 4, 5, and 6 of Patent ’658).
With regards to claim 72, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 60, and Claim 5 of Patent ’658 further recites wherein said reusable, user- powered automatic injection assembly also includes an end cover and said sealing element seating assembly with said plurality of sealing elements mounted thereon is operatively and frictionally engaged with said end cover (see Col. 61, lines 56 – 61 of Patent ’658).
With regards to claim 73, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 60, and Claims 5 and 7 of Patent ’658 further recites wherein at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion (see Col. 61, lines 56 – 61 and Col. 62, lines 1 – 5 of Patent ’658).
With regards to claim 74, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 61, and Claim 7 of Patent ’658 further recites wherein at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion (see Col. 62, lines 1 – 5 of Patent ’658).
With regards to claim 76, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 60, and Claims 5 and 8 of Patent ’658 further recites wherein vacuum is created between said end cover and said plurality of sealing elements during said forward motion (see Col. 61, lines 56 – 61 and Col. 62, lines 6 – 9 of Patent ’658).
With regards to claim 77, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 61, and Claim 8 of Patent ’658 further recites wherein vacuum is created between said end cover and said plurality of sealing elements during said forward motion (see Col. 62, lines 6 – 9 of Patent ’658).
With regards to claim 78, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 62, and Claims 4 and 5 of Patent ’658 further recites wherein vacuum is created between said end cover and said plurality of sealing elements during said forward motion (see Col. 61, lines 51 – 61 of Patent ’658).
With regards to claim 79, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 63, and Claims 4 and 5 of Patent ’658 further recites wherein vacuum is created between said end cover and said plurality of sealing elements during said forward motion (see Col. 61, lines 51 – 61 of Patent ’658).
Claim(s) 75 rejected on the ground of nonstatutory double patenting as being unpatentable over Patent ’658 and Kipfer as applied above in view of Shill.
With regards to claim 75, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 62, however Patent ’658 is silent with regards to wherein at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion.
Nonetheless Shill, which is within the analogous art of surgical pumps (see abstract and title), teaches at least one slot (see Col. 5, lines 13 – 20 “A vent (illustrated by dotted lines) between the upper end of bore 65 and atmosphere permits escape of air trapped between the O-rings 71 and 73”) is formed in said sealing element seating assembly (see at 71 and 73 in Fig. 2) in order to provide air passage of air trapped between said end cover (60) and said plurality of sealing elements (71, 73) during said rearward motion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the sealing element seating assembly of the medicament injector of Patent ’658 and Kipfer in view of a teaching of Shill such that at least one slot is formed in said sealing element seating assembly in order to provide air passage of air trapped between said end cover and said plurality of sealing elements during said rearward motion. One of ordinary skill in the art would have been motivated to make this modification because Shill teaches that the slot permits an escape of air trapped between the O-rings (see Col. 5, lines 13 – 20). This release of air is beneficial because it ensures that the medicament injector operates smoothly and efficiently, preventing operational failures and protecting the device from damage.
Claim(s) 80 – 82 are rejected on the ground of nonstatutory double patenting as being unpatentable over Patent ’658 and Kipfer as applied above, in further view of Helmer.
With regards to claim 80, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 60, and Kipfer teaches wherein said sealing element seating assembly includes a plurality of seating areas at a rearward end thereof (see Col. 6, lines 12 – 39 “The O-rings are received in circumferential grooves of the platform sleeve 10a and in this manner fixed relative to the two opposite surfaces of the housing and the platform sleeve 10a by form fit and force fit” where the circumferential grooves of the platform sleeve 10a are the sealing element seating assembly shown in Fig. 1).
However the medicament injector of Patent ’658 and Kipfer is silent with regards to said seating areas each include a planar surface and a tapered surface.
Nonetheless Helmer, which is within the analogous art of drug delivery devices (see abstract and title)¸ teaches said seating areas each include a planar surface (18) (see [0041]) and a tapered surface (22) (see [0041] and Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shape of each seating area of the medicament injector of Patent ’658 and Kipfer in view of a teaching of Helmer such that said seating areas each include a planar surface and a tapered surface. One of ordinary skill in the art would have been motivated to make this modification because Helmer teaches that this shape of the sealing element seating assembly generates a large friction force or reduced friction force between the O-rings and the end cover depending on which direction the movement is occurring (see [0042] and [0043] of Helmer). This would be advantageous because doing so creates a medicament injector that requires a smaller actuation force to displace the piston in the rearward direction than the force required to move the piston in the forward direction thereby allowing the injector conserve energy when reused.
With regards to claim 81, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 61, and Kipfer teaches wherein said sealing element seating assembly includes a plurality of seating areas at a rearward end thereof (see Col. 6, lines 12 – 39 “The O-rings are received in circumferential grooves of the platform sleeve 10a and in this manner fixed relative to the two opposite surfaces of the housing and the platform sleeve 10a by form fit and force fit” where the circumferential grooves of the platform sleeve 10a are the sealing element seating assembly shown in Fig. 1).
However the medicament injector of Patent ’658 and Kipfer is silent with regards to said seating areas each include a planar surface and a tapered surface.
Nonetheless Helmer, which is within the analogous art of drug delivery devices (see abstract and title)¸ teaches said seating areas each include a planar surface (18) (see [0041]) and a tapered surface (22) (see [0041] and Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shape of each seating area of the medicament injector of Patent ’658 and Kipfer in view of a teaching of Helmer such that said seating areas each include a planar surface and a tapered surface. One of ordinary skill in the art would have been motivated to make this modification because Helmer teaches that this shape of the sealing element seating assembly generates a large friction force or reduced friction force between the O-rings and the end cover depending on which direction the movement is occurring (see [0042] and [0043] of Helmer). This would be advantageous because doing so creates a medicament injector that requires a smaller actuation force to displace the piston in the rearward direction than the force required to move the piston in the forward direction thereby allowing the injector conserve energy when reused.
With regards to claim 82, the medicament injector of Patent ’658 and Kipfer teaches the claimed invention of claim 62, and Kipfer further teaches wherein said sealing element seating assembly includes a plurality of seating areas at a rearward end thereof (see Col. 6, lines 12 – 39 “The O-rings are received in circumferential grooves of the platform sleeve 10a and in this manner fixed relative to the two opposite surfaces of the housing and the platform sleeve 10a by form fit and force fit” where the circumferential grooves of the platform sleeve 10a are the sealing element seating assembly shown in Fig. 1).
However the medicament injector of Patent ’658 and Kipfer is silent with regards to said seating areas each include a planar surface and a tapered surface.
Nonetheless Helmer, which is within the analogous art of drug delivery devices (see abstract and title)¸ teaches said seating areas each include a planar surface (18) (see [0041]) and a tapered surface (22) (see [0041] and Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shape of each seating area of the medicament injector of Patent ’658 and Kipfer in view of a teaching of Helmer such that said seating areas each include a planar surface and a tapered surface. One of ordinary skill in the art would have been motivated to make this modification because Helmer teaches that this shape of the sealing element seating assembly generates a large friction force or reduced friction force between the O-rings and the end cover depending on which direction the movement is occurring (see [0042] and [0043] of Helmer). This would be advantageous because doing so creates a medicament injector that requires a smaller actuation force to displace the piston in the rearward direction than the force required to move the piston in the forward direction thereby allowing the injector conserve energy when reused.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sarkorov et al. (US 10,850,036 B2)
Sarkorov et al. (US 11,040,142 B2)
Sarkorov et al. (US 12,102,797 B2)
Jürg et al. (US 2016/0361494 A1)
Young et al. (US 5,788,673 A)
Haenggi (US 9,889,254 B2)
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
04/16/2026
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