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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/11/2025 has been entered.
Response to Amendment
The Amendment filed on 8/11/2025 has been entered. Claims 1, 3-10, and 12-19 remain pending in the application. Claim 20 is new.
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 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to claim 20,
Line 2 recites “thereto”. It is unclear if thereto refers to the housing, to each other, or to a different structure as claim 1 already states that both the first connector portion and the second connector portion are axially slideable relative to the housing. For examination purposes Examiner construes “thereto” to be “to the housing”. Examiner notes claim 20 does further limit claim 1 since the first connector portion and the second connector portion are claimed as being disposed in the housing. However, since claim 1 already states both the first connector portion and the second connector portion are axially slideable relative to the housing, Examiner suggests removing the limitation “and axially slideable relative thereto”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 10, 12-13, 15, and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a first interpretation of Bayer (U.S. PG publication 20160030678).
In regard to claim 10,
Bayer discloses a connector assembly (figure 1, item 105 and 100) for connecting a stopper (figure 1, item 16; Examiner notes the stopper is not positively required by the claim) to a driving assembly (figure 1, item 40, 50, 60, 70, 90, 110; Examiner notes the driving assembly is not positively required by the claim) in a delivery device (figure 1, item 10 not including the connector assembly 105 and 100; Examiner notes item 105 is connected to item 100 as supported by paragraph [0205]. Item 100 is connected to at least item 70 of the driving assembly as supported at least by paragraph [0207]. Item 105 is connected to item 30 as supported at least by paragraph [0205], item 30 is connected to cartridge holder 12 as supported at least by paragraph [0166], the cartridge holder is connected to cartridge 14 as supported at least by paragraph [0166] and the cartridge is connected to stopper 16 as supported at least by paragraph [0167]. Therefore item 105 is indirectly connected to stopper 16. As a result, since item 105 is connected to item 100, the connector assembly is for connecting a stopper to a driving assembly; Examiner notes the delivery device is not positively required by the claim), comprising:
a first connector portion (figure 1, item 100) for connecting to the driving assembly (Item 100 is connected to at least item 70 of the driving assembly as supported at least by paragraph [0207]); and
a second connector portion (figure 1, item 105) for connecting to the stopper (Examiner notes item 105 is connected to item 30 as supported at least by paragraph [0205], item 30 is connected to cartridge holder 12 as supported at least by paragraph [0166], the cartridge holder is connected to cartridge 14 as supported at least by paragraph [0166] and the cartridge is connected to stopper 16 as supported at least by paragraph [0167]. Therefore item 105 is indirectly connected to item 16), the second connector portion continuously interlocked to the first connector portion (see paragraph [0204]-[0205]; continuously interlocked via item 101 and 107), the first connector portion and the second connector portion continuously interlocked in a manner that allows slideable movement in an axial direction relative to each other (paragraph [0208] and [0027]-[0028]; Examiner notes the term “slideable” as defined by Merriam-Webster dictionary means capable of sliding or of being slid, and “sliding” as defined by Merriam-Webster dictionary means to move smoothly along a surface. As supported by paragraph [0027]-[0028] and [0208] the first connector portion and the second connector portion are continuously interlocked in a manner to allow slideable movement in an axial direction relative to each other) to avoid compression of a medicament in a cartridge (item 14) prior to injection (Examiner notes compression of the medicament in the cartridge prior to injection is avoided as item 105 moves in an axial direction away from the cartridge/medicament in the cartridge and does not directly contact the medicament in the cartridge and therefore would not cause a compression of the medicament as a result of the axially slideable movement. Examiner notes claim 10 does not further elaborate on the specifics of how compression of the medicament in the cartridge prior to injection is avoided. Page 8, line 31-page 9, line 1 of the disclosure states “the connector assembly 1000 is free to move from the extended position to the compressed position without transmission of any load to the stopper 120 because the gear ring 132 contacts the cartridge 110 at the same time that the compressed position of the connector assembly 1000 is achieved. Claim 10 for example does not require the gear ring which seems to function with the connector portions to avoid compression), both the first connector portion and the second connector portion, when disposed in a housing (figure 1, item 30) of the delivery device, are axially displaceable relative to the housing of the delivery device (Examiner notes claim 1 does not specify at what point the first connector portion and the second connector portion are axially displaceable relative to a housing of the delivery device or specify what the first connector portion and the second connector portion being axially displaceable relative to a housing of the delivery device functions to do. As supported by paragraph [0025], during assembly, the first connector portion and the second connector portion are axially displaceable relative to a housing of the delivery device. Examiner further notes the housing is not positively required by the claim).
In regard to claim 12,
Bayer discloses the connector assembly of claim 10, wherein one of the first connector portion and the second connector portion has at least one locking groove (figure 16, item 101; paragraph [0204]-[0205]) formed therein and the other one of the first connector portion and the second connector portion has at least one locking protrusion (figure 16, item 107; paragraph [0205]) disposed in the at least one locking groove to rotationally lock the first connector portion and the second connector portion (paragraph [0205]).
In regard to claim 13,
Bayer discloses the connector assembly of claim 10, wherein one of the first connector portion and the second connector portion has at least one sliding slot (figure 16, item 101; paragraph [0204]-[0205]) formed therein and the other one of the first connector portion and the second connector portion has at least one sliding protrusion (figure 16, item 107; paragraph [0205]) slideably held within the at least one sliding slot (paragraph [0205]).
In regard to claim 15,
Bayer discloses the connector assembly of claim 10, wherein the first connector portion and the second connector portion are telescopically connected to one another (see figure 16).
In regard to claim 18,
Bayer discloses the connector assembly of claim 10, wherein the first connector portion and the second connector portion are continuously interlocked in a manner to allow:
rotation in unison relative to the housing (item 30; paragraph [0205] and [0207]).
In regard to claim 19,
Bayer discloses the connector assembly of 18, wherein the first connector portion and the second connector portion remain continuously interlocked as the first connector portion and the second connector portion are allowed to rotate in unison relative to the housing (paragraph [0205] and [0207]).
Claims 1, 6-10, 15, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a second interpretation of Bayer (U.S. PG publication 20160030678). Examiner notes the second interpretation differs from the first regarding the connector assembly.
In regard to claim 1,
Bayer discloses a delivery device (figure 1, item 10) for delivering a medicament to a patient (paragraph [0166]), comprising:
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a cartridge (figure 1, item 14) disposed within a housing (figure 1, item 12 and 30), the cartridge having a first end (see figure 1 above) sealed by a septum (paragraph [0166]: wherein the cartridge is sealed by a septum in the distal direction 1) and a second open end (see figure 1 above: wherein the opposite end of the cartridge is open and receives piston 16 and rod 90; paragraph [0167]) longitudinally opposed to the first end (see figure 1) and defining a cartridge volume (see figure 1 above) for holding the medicament (paragraph [0166]);
a stopper (figure 1, item 16) at least partially disposed within the cartridge volume (see figure 1) and displaceable within the cartridge volume to eject the medicament from the cartridge through the septum (paragraph [0167]);
a driving assembly (figure 1, item 40, 50, 60, 70, 110 and also figure 17, item 91 which is a pressure piece) connected to the stopper (see figure 1, 2, and 17, wherein the components of the driving assembly are connected to the stopper via item 90) having a rotatable portion (figure 1, item 60; paragraph [0206]) cooperatively engaged to an extendable portion (figure 17, item 91; paragraph [0213], [0215] and [0206]: clutch 60 is cooperatively engaged to the piston rod 90. The extendable portion/pressure piece 91 is attached to the rod of the piston rod 90) such that rotation of the rotatable portion causes axial translation of the extendable portion (paragraph [0215] and [0206]: wherein clutch 60 causes rotation of clutch 70 which causes axial translation of the piston rod 90 and extendable portion/pressure piece 91); and
a connector assembly (figure 17 and 1, item 105 and item 90 not including pressure piece 91) having a first connector portion (figure 1, item 90) connected to the extendable portion (see figure 17) and a second connector portion (figure 1, item 105) connected to the stopper (Examiner notes item 105 is connected to item 30 as supported at least by paragraph [0205], item 30 is connected to cartridge holder 12 as supported at least by paragraph [0166], the cartridge holder is connected to cartridge 14 as supported at least by paragraph [0166] and the cartridge is connected to stopper 16 as supported at least by paragraph [0167]. Therefore item 105 is indirectly connected to item 16. Examiner further notes item 105 is also indirectly connected to item 16 via 30, 34, 90, and 91), the first connector portion and the second connector portion being continuously interlocked to each other (Examiner notes the first connector portion and the second connector portion are continuously interlocked to each other via item 30, as threads of item 90 are engaged with item 34 of item 30 as described in paragraph [0172] and item 105 is also threadedly engaged with item 30 as described in paragraph [0205]), the first connector portion and the second connector portion continuously interlocked in a manner to allow slideable movement in an axial direction relative to each other (paragraph [0039], [0208], [0027]-[0028], [0210]; Examiner notes the term “slideable” as defined by Merriam-Webster dictionary means capable of sliding or of being slid, and “sliding” as defined by Merriam-Webster dictionary means to move smoothly along a surface. As supported by paragraph [0039], [0208], [0027]-[0028], [0210] the first connector portion and the second connector portion are continuously interlocked in a manner to allow slideable movement in an axial direction relative to each other as item 105 is axially moveable relative to item 90) to avoid compression of the medicament in the cartridge prior to injection (Examiner notes compression of the medicament in the cartridge prior to injection is avoided as item 105 moves in an axial direction away from the cartridge/medicament in the cartridge as supported by paragraph [0039] and does not directly contact the medicament in the cartridge and therefore would not cause a compression of the medicament as a result of the axially slideable movement. Examiner notes claim 1 does not further elaborate on the specifics of how compression of the medicament in the cartridge prior to injection is avoided. Page 8, line 31-page 9, line 1 of the disclosure states “the connector assembly 1000 is free to move from the extended position to the compressed position without transmission of any load to the stopper 120 because the gear ring 132 contacts the cartridge 110 at the same time that the compressed position of the connector assembly 1000 is achieved. Claim 1 for example does not require the gear ring which seems to function with the connector portions to avoid compression), both the first connector portion and the second connector portion are axially slideable relative to the housing (paragraph [0171] and [0208]).
In regard to claim 6,
Bayer discloses the delivery device of claim 1, wherein the first connector portion and the second connector portion are telescopically connected to one another (see figure 16).
In regard to claim 7,
Bayer discloses the delivery device of claim 1, wherein the first connector portion and the second connector portion are configured to axially displace relative to one another when an axial load is applied to at least one of the driving assembly and the cartridge (paragraph [0210] and [0188]; Examiner notes during dose setting and dose dispensing the first connector portion and the second connector portion are configured to axially displace relative to one another when an axial load is applied to at least one of the driving assembly and the cartridge).
In regard to claim 8,
Bayer discloses the delivery device of claim 1, wherein the connector assembly is configured to prevent pressurization of the medicament when a gap between the driving assembly and the cartridge closes (see paragraph [0225]; Examiner notes the claim does not require the gap to be closed completely. When item 70 is initially displaced to close a gap between the driving assembly and the cartridge, and as a result item 70 becomes rotationally coupled with item 80, but a further displacement of 70 is still possible, the connector assembly is fully capable of preventing pressurization of the medicament as the connector assembly does not put pressure on the medicament due to the structure/placement within the delivery device. Examiner notes “configured to prevent pressurization of the medicament when a gap between the driving assembly and the cartridge closes” is a functional limitation. The claim is not specific as to what the connector assembly does/how it interacts with other components to prevent pressurization of the medicament when a gap between the driving assembly and the cartridge closes).
In regard to claim 9,
Bayer discloses the delivery device of claim 1, wherein the housing houses the cartridge and the driving assembly (see figure 1).
In regard to claim 10,
Bayer discloses a connector assembly (figure 17 and 1, item 105 and item 90) for connecting a stopper (figure 1, item 16; Examiner notes the stopper is not positively required by the claim) to a driving assembly (figure 1, item 40, 50, 60, 70, 110; Examiner notes the driving assembly is not positively required by the claim) in a delivery device (figure 1, item 10 not including the connector assembly 105 and 90; Examiner notes item 105 is connected to item 30 as supported at least by paragraph [0205], and item 90 is also connected to item 30 as supported by paragraph [0172]. Item 90 is connected to the stopper and item 105 is connected to the driving assembly via item 100, therefore the connector assembly functions to connect a stopper to a driving assembly; Examiner notes the delivery device is not positively required by the claim), comprising:
a first connector portion (figure 1, item 105) for connecting to the driving assembly (Item 105 is connected to item 100, and item 100 is connected to at least item 70 of the driving assembly as supported at least by paragraph [0207]); and
a second connector portion (figure 1, item 90) for connecting to the stopper (see figure 17 and 1), the second connector portion continuously interlocked to the first connector portion (Examiner notes the first connector portion and the second connector portion are continuously interlocked to each other via item 30, as threads of item 90 are engaged with item 34 of item 30 as described in paragraph [0172] and item 105 is also threadedly engaged with item 30 as described in paragraph [0205]), the first connector portion and the second connector portion continuously interlocked in a manner that allows slideable movement in an axial direction relative to each other (paragraph [0039], [0208], [0027]-[0028], [0210]; Examiner notes the term “slideable” as defined by Merriam-Webster dictionary means capable of sliding or of being slid, and “sliding” as defined by Merriam-Webster dictionary means to move smoothly along a surface. As supported by paragraph [0039], [0208], [0027]-[0028], [0210] the first connector portion and the second connector portion are continuously interlocked in a manner to allow slideable movement in an axial direction relative to each other as item 105 is axially moveable relative to item 90) to avoid compression of a medicament in a cartridge of the delivery device prior to injection (Examiner notes compression of a medicament in a cartridge prior to injection is avoided as item 105 moves in an axial direction away from the cartridge/medicament in the cartridge as supported by paragraph [0039] and does not directly contact the medicament in the cartridge and therefore would not cause a compression of the medicament as a result of the axially slideable movement. Examiner notes claim 10 does not further elaborate on the specifics of how compression of the medicament in the cartridge prior to injection is avoided. Page 8, line 31-page 9, line 1 of the disclosure states “the connector assembly 1000 is free to move from the extended position to the compressed position without transmission of any load to the stopper 120 because the gear ring 132 contacts the cartridge 110 at the same time that the compressed position of the connector assembly 1000 is achieved. Claim 10 for example does not require the gear ring which seems to function with the connector portions to avoid compression), both the first connector portion and the second connector portion, when disposed in a housing (figure 1, item 30) of the delivery device, are axially displaceable relative to the housing of the delivery device (paragraph [0171] and [0208]; Examiner notes the housing is not positively required by the claim).
In regard to claim 15,
Bayer discloses the connector assembly of claim 10, wherein the first connector portion and the second connector portion are telescopically connected to one another (see figure 16).
In regard to claim 20,
Bayer discloses the delivery device of claim 1, wherein both the first connector portion and the second connector portion are disposed in the housing (see figure 1 and 17) and axially slideable relative thereto (see analysis of claim 1 above).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 14 is rejected under 35 U.S.C. 103 as being unpatentable over the first interpretation of Bayer (U.S. PG publication 20160030678) further in view of Plumptre (U.S. PG publication 20150224266).
In regard to claim 14,
Bayer discloses the connector assembly of claim 13.
Bayer is silent as to wherein the at least one sliding protrusion includes a chamfer.
Plumptre teaches wherein the at least one sliding protrusion (rib of item 50; see paragraph [0126]) includes a chamfer (paragraph [0126]; Examiner notes the slot that receives item 50 is also shaped accordingly to mate with the protrusion of item 50).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one sliding protrusion of Bayer to include a chamfer and to modify the slot 101 of Bayer to be shaped accordingly, as taught by Plumptre, for the purpose of encouraging proper assembly (paragraph [0126] of Plumptre).
Allowable Subject Matter
Claims 3-5, and 16-17 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.
The following is a statement of reasons for the indication of allowable subject matter:
In regard to claim 3,
The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations the delivery device of claim 1, wherein one of the first connector portion and the second connector portion has at least one locking groove formed therein and the other one of the first connector portion and the second connector portion has at least one locking protrusion disposed in the at least one locking groove to rotationally lock the first connector portion and the second connector portion. As shown in figure 17 of Bayer (U.S. PG publication 20160030678), the first connector portion 90 and the second connector portion 105 are not directly engaged with each other. Therefore, Bayer fails to disclose the limitations of claim 3.
In regard to claim 4,
The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations the delivery device of claim 1, wherein one of the first connector portion and the second connector portion has at least one sliding slot formed therein and the other one of the first connector portion and the second connector portion has at least one sliding protrusion slideably held within the at least one sliding slot. As shown in figure 17 of Bayer (U.S. PG publication 20160030678), the first connector portion 90 and the second connector portion 105 are not directly engaged with each other. Therefore, Bayer fails to disclose the limitations of claim 4.
Dependent claim 5 would be allowable by virtue of being dependent upon allowable claim 4.
In regard to claim 16,
The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations the delivery device of claim 1, wherein the first connector portion and the second connector portion are continuously interlocked in a manner to allow: rotation in unison relative to the housing. The first connector portion 90 and the second connector portion 105 of Bayer (U.S. PG publication 20160030678) do not rotate in unison relative to the housing. Therefore, Bayer fails to disclose the limitations of claim 16.
Dependent claim 17 would be allowable by virtue of being dependent upon allowable claim 16.
Response to Arguments
Applicant’s arguments regarding claim 1 and the claims that depend on claim 1 are moot in view of a new interpretation of Bayer i.e. the second interpretation detailed above. Applicant argues that “there is no requirement to recite the function of a distinguishing claim feature and the Office does not cite to any authority in the Advisory Action to the contrary”. Examiner did not state that the function was required in the Advisory Action, but was instead providing a suggestion in an attempt to advance prosecution. Applicant's arguments in regard to claim 10 and the claims that depend on claim 10 have been fully considered but they are not persuasive. Applicant argues that similar to claim 1, Bayer fails to disclose “both the first connector portion and the second connector portion, when disposed in a housing of the delivery device, are axially displaceable relative to the housing of the delivery device”. Examiner respectfully disagrees. Claim 10 is vastly different than claim 1. Claim 10 does not positively require the stopper, driving assembly, delivery device, or housing. The limitations of claim 10 also do not require the delivery device to be fully assembled, as argued in regard to claim 1, when the first connector portion and the second connector portion are disposed in a housing of the delivery device and axially displaceable. As supported by paragraph [0025] of Bayer, during assembly, the first connector portion and the second connector portion when disposed in a housing of the delivery device are axially displaceable relative to the housing of the delivery device. Therefore, Applicant’s arguments in regard to claim 10 and the claims that depend on claim 10 are not persuasive. Additionally, claim 10 has been rejected in view of the second interpretation of Bayer detailed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783