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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/23/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The term “needle holder” does not appear in the specification. As best understood by the Examiner, the needle holder is the needle hub.
The disclosure is objected to because of the following informalities:
Under the heading “Cross-Reference to Related Applications”, U.S. patent application 16727609 is referenced. Application 16727609 has been patented as U.S. patent 12076534. The specification should be amended to include that application 16727609 has been patented as U.S. patent 12076534.
Appropriate correction is required.
The abstract of the disclosure is objected to because “The disclosure relates to medicament delivery device” is grammatically incorrect. Examiner suggests replacing “The disclosure relates to medicament delivery device” with “The disclosure relates to a medicament delivery device”.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 29 is objected to because of the following informalities:
Line 21-22 recites “(ii) the piston is distally driven towards the needle to dispense a medicament from the medicament cartridge through the needle”. Line 18-22 recites “depressing the trigger element allows (i) the medicament cartridge and the needle to move toward one another such that the proximal end of the needle pierces the sealing member and places the needle in fluid communication with the medicament cartridge, and (ii) the piston is distally driven towards the needle to dispense a medicament from the medicament cartridge through the needle”. Examiner notes depressing the trigger element allows (ii) the piston is distally driven towards the needle to dispense a medicament from the medicament cartridge through the needle is grammatically incorrect. Examiner suggests replacing “(ii) the piston is distally driven towards the needle to dispense a medicament from the medicament cartridge through the needle” in line 21-22 with “(ii) the piston to be distally driven towards the needle to dispense a medicament from the medicament cartridge through the needle”
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 27 and 31-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regard to claim 27,
Line 1-4 recites “wherein the medicament delivery device is configured to move the needle holder distally towards a portion of the housing and engage the portion of the housing to limit further distal movement of the needle holder relative to housing”. Claim 27 is not an originally filed claim. There does not appear to be support in the original disclosure for this limitation. As best understood by the Examiner, the needle holder is a hub, item 5.4 (see figure 5 for example), which does not appear to be able to be moved by the medicament delivery device distally towards a portion of the housing and engage the portion of the housing to limit further distal movement of the needle holder relative to housing. An unlabeled portion in the figures, which receives a neck of the cartridge, appears to move relative to item 9 as shown in figure 2 of the instant disclosure compared to figure 1. However, the unlabeled portion does not appear to be a needle holder, as the unlabeled portion appears to move relative to the needle as depicted in the figures and therefore does not appear to hold the needle.
In regard to claim 31,
Line 2-3 recites “the medicament delivery device is configured to distally move the needle holder relative to the housing when the trigger element is depressed”. Claim 31 is not an originally filed claim. There does not appear to be support in the original disclosure for this limitation. As best understood by the Examiner, the needle holder is a hub, item 5.4 (see figure 5 for example), which does not appear to be able to be distally moved by the medicament delivery device relative to the housing when the trigger element is depressed. An unlabeled portion in the figures, which receives a neck of the cartridge, appears to move relative to item 9 as shown in figure 2 of the instant disclosure compared to figure 1. However, the unlabeled portion does not appear to be a needle holder, as the unlabeled portion appears to move relative to the needle as depicted in the figures and therefore does not appear to hold the needle.
In regard to claim 32,
Line 1-4 recites “wherein the medicament delivery device is configured such that when the trigger element is depressed the needle holder distally moves relative to the housing towards a portion of the housing and engages the portion of the housing to limit further distal movement of the needle holder relative to housing”. Claim 32 is not an originally filed claim. There does not appear to be support in the original disclosure for this limitation. As best understood by the Examiner, the needle holder is a hub , item 5.4 (see figure 5 for example). The medicament delivery device does not appear to be configured such that when the trigger element is depressed the needle holder distally moves relative to the housing towards a portion of the housing and engages the portion of the housing to limit further distal movement of the needle holder relative to housing. An unlabeled portion in the figures, which receives a neck of the cartridge, appears to move relative to item 9 as shown in figure 2 of the instant disclosure compared to figure 1. However, the unlabeled portion does not appear to be a needle holder, as the unlabeled portion appears to move relative to the needle as depicted in the figures and therefore does not appear to hold the needle.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-44 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 16,
Line 12 recites “the sidewall”. A sidewall of the member has been introduced in line 11 of claim 16 and a sidewall of the housing has been introduced in line 12 of claim 16. It is unclear which sidewall “the sidewall” refers to. For examination purposes Examiner construes “the sidewall” to be “the sidewall of the member”. Examiner suggests replacing “the sidewall” in line 12 of claim 16 with “the sidewall of the member”.
Examiner notes claims 17-28 are similarly rejected by virtue of their dependency on claim 16.
In regard to claim 22,
Line 2-3 recites “the medicament delivery device is configured to insert the hollow needle through the opening into a patient”. The hollow needle is claimed as a component of the medicament delivery device in claim 16. It is unclear how the medicament delivery device is configured to insert the hollow needle through the opening into a patient since the medicament delivery device includes the hollow needle. It appears a portion of the medicament delivery device is configured to insert the hollow needle through the opening into a patient. For examination purposes Examiner construes “the medicament delivery device is configured to insert the hollow needle through the opening into a patient” to be “a portion of the medicament delivery device is configured to insert the hollow needle through the opening into a patient”. Examiner suggests clarifying which portion of the medicament delivery device is configured to insert the hollow needle through the opening into a patient.
Line 3 recites “the opening”. Line 2 of claim 22 recites “an opening in the housing”. Claim 16, which claim 22 depends on, recites “a proximal opening” and “a distal opening”. It is unclear which opening “the opening” in line 3 refers to. For examination purposes Examiner construes “the opening” to be “the opening in the housing”. Examiner suggests replacing “the opening” in line 3 of claim 22 with “the opening in the housing”.
Examiner notes claim 23 is similarly rejected by virtue of its dependency on claim 22.
In regard to claim 27,
Line 1-2 recites “wherein the medicament delivery device is configured to move the needle holder distally towards a portion of the housing”. The needle holder and housing are claimed as a component of the medicament delivery device in claim 16. It is unclear how the medicament delivery device is configured to move the needle holder distally towards a portion of the housing since the medicament delivery device includes the needle holder and the housing. It appears a portion of the medicament delivery device is configured to move the needle holder distally towards a portion of the housing. For examination purposes Examiner construes “the medicament delivery device is configured to move the needle holder distally towards a portion of the housing” to be “a portion of the medicament delivery device is configured to move the needle holder distally towards a portion of the housing”. Examiner suggests clarifying which portion of the medicament delivery device is configured to move the needle holder distally towards a portion of the housing.
Line 2-4 recites “and engage the portion of the housing to limit further distal movement of the needle holder relative to housing”. It is unclear how the medicament delivery device is configured to engage the portion of the housing to limit further distal movement of the needle holder relative to housing since the medicament delivery device includes the housing and the needle holder. It is unclear what structure engages the portion of the housing to limit further distal movement of the needle holder relative to housing. For examination purposes Examiner construes “wherein the medicament delivery device is configured to move the needle holder distally towards a portion of the housing and engage the portion of the housing to limit further distal movement of the needle holder relative to housing” to be “wherein a portion of the medicament delivery device is configured to move the needle holder distally towards a portion of the housing to engage the portion of the housing to limit further distal movement of the needle holder relative to housing”. Examiner suggests clarifying which portion of the medicament delivery device engages the portion of the housing to limit further distal movement of the needle holder relative to housing.
In regard to claim 29,
Line 6 recites “a distal end of the medicament cartridge”. Line 4 recites “a distal end of the medicament cartridge”. It is unclear if the distal end of the medicament cartridge in line 6 is a second distal end of the medicament cartridge or is the same as the distal end of the medicament cartridge introduced in line 4. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “a distal end of the medicament cartridge” in line 6 of claim 29 with “the distal end of the medicament cartridge”.
Line 7 recites “a proximal end of the medicament cartridge”. Line 5 recites “a proximal end of the medicament cartridge”. It is unclear if the proximal end of the medicament cartridge in line 7 is a second proximal end of the medicament cartridge or is the same as the proximal end of the medicament cartridge introduced in line 5. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “a proximal end of the medicament cartridge” in line 67of claim 29 with “the proximal end of the medicament cartridge”.
Examiner notes claims 30-34 are similarly rejected by virtue of their dependency on claim 29.
In regard to claim 30,
Line 5 recites “the sidewall”. A sidewall of the member has been introduced in line 4 of claim 30 and a sidewall of the housing has been introduced in line 4-5 of claim 30. It is unclear which sidewall “the sidewall” refers to. For examination purposes Examiner construes “the sidewall” to be “the sidewall of the member”. Examiner suggests replacing “the sidewall” in line 5 of claim 30 with “the sidewall of the member”.
In regard to claim 31,
Line 2-3 recites “the medicament delivery device is configured to distally move the needle holder relative to the housing when the trigger element is depressed”. The housing is claimed as a component of the medicament delivery device. It is unclear how the medicament delivery device is configured to distally move the needle holder relative to the housing when the trigger element is depressed since the medicament delivery device includes the housing. It appears a portion of the medicament delivery device is configured to distally move the needle holder relative to the housing when the trigger element is depressed. For examination purposes Examiner construes “the medicament delivery device is configured to distally move the needle holder relative to the housing when the trigger element is depressed” to be “a portion of the medicament delivery device is configured to distally move the needle holder relative to the housing when the trigger element is depressed”. Examiner suggests clarifying which portion of the medicament delivery device is configured to distally move the needle holder relative to the housing when the trigger element is depressed.
Examiner notes claim 32 is similarly rejected by virtue of its dependency on claim 31.
In regard to claim 35,
Line 6 recites “a distal end of the medicament cartridge”. Line 4 recites “a distal end of the medicament cartridge”. It is unclear if the distal end of the medicament cartridge in line 6 is a second distal end of the medicament cartridge or is the same as the distal end of the medicament cartridge introduced in line 4. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “a distal end of the medicament cartridge” in line 6 of claim 35 with “the distal end of the medicament cartridge”.
Line 17-18 recites “which causes the medicament cartridge and the medicament cartridge to move toward one another”. It is unclear what is meant by this. Based on the disclosure it appears the medicament cartridge and the needle move toward one another. For examination purposes Examiner construes “which causes the medicament cartridge and the medicament cartridge to move toward one another” to be “which causes the medicament cartridge and the needle to move toward one another”. Examiner suggests replacing “which causes the medicament cartridge and the medicament cartridge to move toward one another” in line 17-18 of claim 35 with “which causes the medicament cartridge and the needle to move toward one another”.
Examiner notes claims 36-44 are similarly rejected by virtue of their dependency on claim 35.
In regard to claim 39,
Line 2 recites “a medicament”. Claim 35, which claim 39 depends on, introduces a medicament. It is unclear if the medicament in claim 39 is a second medicament or if the medicament in claim 39 is intended to be the same medicament as in claim 35. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “a medicament” in claim 39 with “the medicament”.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 16-24, 27, and 29-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marshall (U.S. Patent no 6077247).
In regard to claim 16,
Marshall discloses a medicament delivery device (see all of figure 1; Examiner notes the device is construed as a medicament delivery device as it is fully capable of delivering a medicament) comprising:
a housing (figure 1, item 3 and 10, not including item 11);
a medicament cartridge (figure 1, item 1; Examiner notes the cartridge is construed as a medicament cartridge as it is fully capable of containing a medicament) contained in the housing (see figure 1), the medicament cartridge comprising a proximal end defining a proximal opening (see figure 1; column 2, line 53-60 wherein the spring can act on item 24), a distal end defining a distal opening (see figure 1), a sealing element (figure 1, item 23) covering the distal opening (see figure 1), and a piston (figure 1, item 24) disposed within the medicament cartridge (see figure 1);
a hollow needle (figure 1, item 2) attached to a needle holder (figure 1, item 21; column 2, line 36-39) within the housing (see figure 1), the hollow needle, in an initial position (see position shown in figure 1), being distally spaced from the sealing element covering the distal opening of the medicament cartridge such that the hollow needle is not in fluid communication with medicament in the medicament cartridge (column 2, line 39-42 and column 2, line 58-65);
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a member (see figure 1 above wherein a portion of item 11 forms the member) disposed within the housing (see figure 1), the member being movable relative to the medicament cartridge (see position in figure 4 as compared to figure 1), and the member comprising (i) a sidewall extending substantially parallel to a sidewall of the housing (see figure 1) and (ii) a distal portion (figure 1, item 14) extending radially inward from the sidewall (see figure 1);
a piston drive member (figure 1, item 20) configured to be advanced within the medicament cartridge (column 2, line 53-60);
a removable needle cover (figure 1, item 18 and 19; see figure 3 in which the removable needle cover has been removed) configured to be inserted into the housing (see figure 1) such that when the removable needle cover is inserted into the housing the removable needle cover has a first portion (figure 1, item 18) that protrudes from the housing (see figure 1); and
a trigger element (see figure 1 wherein the rear part of item 11 which does not form the member and is accessible through slot 7 is construed as the trigger element; column 2, line 53-56), wherein the medicament delivery device is configured such that actuation of the trigger element allows (i) relative movement between the medicament cartridge and the member (column 4, line 53-65) and (ii) the hollow needle to be placed in fluid communication with the medicament in the medicament cartridge (column 4, line 53-65).
In regard to claim 17,
Marshall discloses the medicament delivery device of claim 16, wherein the medicament delivery device is configured such that removal of the removable needle cover from the housing allows the member to be moved relative to the medicament cartridge to place the hollow needle in fluid communication with the medicament in the medicament cartridge (column 4, line 53-65).
In regard to claim 18,
Marshall discloses the medicament delivery device of claim 16, wherein the medicament delivery device is configured such that actuation of the trigger element causes the medicament cartridge to move axially relative to the housing (column 4, line 53-65).
In regard to claim 19,
Marshall discloses the medicament delivery device of claim 16, wherein the medicament delivery device is configured such that actuation of the trigger element causes the piston to be advanced within the medicament cartridge to dispense the medicament in the medicament cartridge through the hollow needle after the hollow needle has been placed in fluid communication with the medicament in the medicament cartridge (column 4, line 53-65).
In regard to claim 20,
Marshall discloses the medicament delivery device of claim 19, wherein the medicament cartridge comprises a cylindrical body defining a chamber (see figure 1) for containing the medicament (Examiner notes “for containing the medicament” is a functional limitation. The chamber is fully capable of the recited function due to its structure) and the piston is disposed in the chamber (see figure 1), wherein the piston seals the proximal opening of the medicament cartridge such that the medicament is contained in the chamber between the piston and the sealing element before the medicament is dispensed from the medicament cartridge (see figure 1).
In regard to claim 21,
Marshall discloses the medicament delivery device of claim 16, wherein the removable needle cover, when inserted into the housing, is configured to prevent the medicament from being dispensed from the medicament cartridge (Examiner notes “configured to prevent the medicament from being dispensed from the medicament cartridge” is a functional limitation. The removable needle cover is fully capable of the recited function as the removable needle cover blocks fluid from exiting the needle) .
In regard to claim 22,
Marshall discloses the medicament delivery device of claim 16, wherein the hollow needle is aligned with an opening in the housing (see figure 1), and the medicament delivery device is configured to insert the hollow needle through the opening into a patient (see figure 5).
In regard to claim 23,
Marshall discloses the medicament delivery device of claim 22, wherein the hollow needle is disposed in a receptacle of the removable needle cover(see figure 1) and covered by the removable needle cover when the removable needle cover is inserted into the housing (see figure 1).
In regard to claim 24,
Marshall discloses the medicament delivery device of claim 16, wherein the hollow needle is disposed in the housing parallel to the medicament cartridge (see figure 1) and has a proximal end (figure 1, item 22) and a distal end (column 2, line 35-42), and the proximal end of the hollow needle is configured to pierce the sealing element covering the distal opening of the medicament cartridge to place the hollow needle in fluid communication with the medicament in the medicament cartridge (column 2, line 61-65).
In regard to claim 27,
Marshall discloses the medicament delivery device of claim 16, wherein the medicament delivery device is configured to move the needle holder distally towards a portion of the housing (see position of needle holder in figure 5 compared to figure 4) and engage the portion of the housing to limit further distal movement of the needle holder relative to housing (see figure 5).
In regard to claim 29,
Marshall discloses a medicament delivery device (see all of figure 1; Examiner notes the device is construed as a medicament delivery device as it is fully capable of delivering a medicament) comprising:
a housing (figure 1, item 3 and 10, not including item 11);
a medicament cartridge (figure 1, item 1; Examiner notes the cartridge is construed as a medicament cartridge as it is fully capable of containing a medicament) disposed within the housing (see figure 1) such that (i) a distal end of the housing is distal to a distal end of the medicament cartridge (see figure 1), and (ii) a proximal end of the housing is proximal to a proximal end of the medicament cartridge (see figure 1), the medicament cartridge comprising (i) a sealing member (figure 1, item 23) disposed at a distal end of the medicament cartridge (see figure 1) and (ii) a piston (figure 1, item 24) disposed at a proximal end of the medicament cartridge (see figure 1);
a needle (figure 1, item 2) disposed within the housing (see figure 1), the needle having a distal end (end opposite item 22) and a proximal end (figure 1, item 22); and
a cover (figure 1, item 18 and 19) removably attached to the medicament delivery device (see figure 3) such that when the cover is attached to the medicament delivery device (i) distal movement of the medicament cartridge relative to the housing is limited (see figure 1; column 2, line 53-65; Examiner notes distal movement of the medicament cartridge relative to the housing is limited as the device cannot be operated until the cover is removed) and (ii) the medicament cartridge and the proximal end of the needle remain spaced apart from one another (see figure 1), the medicament delivery device being configured such that after the cover has been removed from the medicament delivery device the medicament cartridge and the needle remain spaced apart from one another until a trigger element (rear part of item 11 that is accessible through slot 7 as shown in figure 2) has been depressed (column 2, line 53-65),
wherein the medicament delivery device is configured such that after the cover has been removed from the medicament delivery device depressing the trigger element allows (i) the medicament cartridge and the needle to move toward one another such that the proximal end of the needle pierces the sealing member and places the needle in fluid communication with the medicament cartridge (column 2, line 53-65), and (ii) the piston is distally driven towards the needle to dispense a medicament from the medicament cartridge through the needle (column 2, line 53-65; Examiner notes “configured such that after the cover has been removed from the medicament delivery device depressing the trigger element allows (i) the medicament cartridge and the needle to move toward one another such that the proximal end of the needle pierces the sealing member and places the needle in fluid communication with the medicament cartridge and (ii) the piston is distally driven towards the needle to dispense a medicament from the medicament cartridge through the needle” is a functional limitation. A medicament is fully capable of being dispensed due to the piston and the structure of the device).
In regard to claim 30,
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Marshall discloses the medicament delivery device of claim 29, comprising a member (see figure 1 above wherein a portion of item 11 forms the member) disposed within the housing (see figure 1) and configured to remain in a first position when the cover is attached to the medicament delivery device to limit distal movement of the medicament cartridge relative to the housing (see figure 1; column 2, line 53-65), the member comprising (i) a sidewall (see figure 1) extending substantially parallel to a sidewall of the housing (see figure 1) and (ii) a distal portion (figure 1, item 14) extending radially inward from the sidewall (see figure 1).
In regard to claim 31,
Marshall discloses the medicament delivery device of claim 29, wherein the needle is disposed in a needle holder (figure 1, item 21), and the medicament delivery device is configured to distally move the needle holder relative to the housing when the trigger element is depressed (see position of needle holder in figure 5 compared to figure 4).
In regard to claim 32,
Marshall discloses the medicament delivery device of claim 31, wherein the medicament delivery device is configured such that when the trigger element is depressed the needle holder distally moves relative to the housing towards a portion of the housing (see position of needle holder in figure 5 compared to figure 4) and engages the portion of the housing to limit further distal movement of the needle holder relative to housing (see position of needle holder in figure 5 compared to figure 4).
In regard to claim 33,
Marshall discloses the medicament delivery device of claim 29, wherein the housing is an elongated housing (see figure 1), and the medicament cartridge is disposed within the elongated housing such that the elongated housing extends an entire length of the medicament cartridge (see figure 1).
In regard to claim 34,
Marshall discloses the medicament delivery device of claim 29, comprising a first part (figure 1, item 21) disposed in the housing (see figure 1), the first part comprising a proximally-extending portion having a proximal end configured to engage a distal neck of the medicament cartridge (see figure 5) to couple distal movement of the medicament cartridge to the first part (see figure 5 compared to figure 4), the first part configured to move distally within the housing when forced distally by the medicament cartridge (see figure 5 compared to figure 4).
Claims 35-39 and 42-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sarnoff (U.S. Patent no 3811441).
In regard to claim 35,
Sarnoff discloses a medicament delivery device (see all of figure 2 and 3; column 3, line 11-17) comprising:
a housing (figure 2, item 12 and 39);
a medicament cartridge (figure 2, item 28; column 2, line 51-56) disposed within the housing (see figure 2) such that (i) a distal end of the housing is distal to a distal end of the medicament cartridge (see figure 2), and (ii) a proximal end of the housing is proximal to a proximal end of the medicament cartridge (see figure 2), the medicament cartridge comprising (i) a sealing member (figure 2, item 32) disposed at a distal end of the medicament cartridge (see figure 2) and (ii) a piston (figure 2, item 34) disposed within the medicament cartridge (see figure 2), wherein a medicament is located between the piston and the sealing member (column 2, line 51-56);
a needle (figure 2, item 54) disposed within the housing (see figure 2), the needle having a distal end (figure 2, item 55) and a proximal end (end opposite item 55); and
a cover (figure 2, item 52) removably attached to the medicament delivery device (see figure 3 where the cover has been removed) such that when the cover is attached to the medicament delivery device (i) the medicament cartridge and the needle are prevented from moving relative to one another (see figure 2; the medicament cartridge and the needle are prevented from moving relative to one another when the cover is attached and the device is in the position shown in figure 2) and (ii) a first portion of the cover is outward of the housing and can be grabbed by a user (see figure 2),
wherein the medicament delivery device is configured such that after the user removes the cover from the medicament delivery device, the medicament cartridge and the needle remain spaced apart from one another (column 3, line 1-17) until a trigger element is actuated which causes the medicament cartridge and the medicament cartridge to move toward one another such that the proximal end of the needle pierces the sealing member of the medicament cartridge (see figure 3) and places the needle in fluid communication with the medicament within the medicament cartridge (see figure 3; Examiner notes “wherein the medicament delivery device is configured such that after the user removes the cover from the medicament delivery device, the medicament cartridge and the needle remain spaced apart from one another until a trigger element is actuated which causes the medicament cartridge and the medicament cartridge to move toward one another such that the proximal end of the needle pierces the sealing member of the medicament cartridge and places the needle in fluid communication with the medicament within the medicament cartridge” is a functional limitation. The trigger element is not positively required by the claim. The medicament delivery device is fully capable of the recited function due to its structure ).
In regard to claim 36,
Sarnoff discloses the medicament delivery device of claim 35, wherein the medicament delivery device is configured such that after the cover has been removed from the medicament delivery device distal movement of the medicament cartridge is allowed (column 3, line 1-17).
In regard to claim 37,
Sarnoff discloses the medicament delivery device of claim 35, wherein the medicament delivery device is configured such that after the cover has been removed from the medicament delivery device the medicament cartridge and the needle are allowed to move relative to one another (column 3, line 1-17).
In regard to claim 38,
Sarnoff discloses the medicament delivery device of claim 35, wherein the medicament delivery device is configured such that a distally-directed force moves the medicament cartridge toward the needle when the trigger element of the medicament delivery device is actuated (column 3, line 1-17; As noted above the trigger element is not positively required by the claim).
In regard to claim 39,
Sarnoff discloses the medicament delivery device of claim 38, wherein the medicament delivery device is configured to dispense a medicament from the medicament cartridge into the user when the trigger element of the medicament delivery device is actuated (column 3, line 1-17).
In regard to claim 42,
Sarnoff discloses the medicament delivery device of claim 40, comprising a piston drive member (figure 3, item 44) disposed within the housing (see figure 3), the piston drive member having a distal end configured to engage the piston within the medicament cartridge to force the piston in a distal direction relative to the medicament cartridge and expel the medicament from the medicament cartridge through the needle when the needle is in fluid communication with the medicament cartridge (column 3, line 1-17).
In regard to claim 43,
Sarnoff discloses the medicament delivery device of claim 42, wherein the medicament delivery device is configured such that the piston drive member does not move distally within the housing until after the needle has been placed in fluid communication with the medicament cartridge (Examiner notes configured such that the piston drive member does not move distally within the housing until after the needle has been placed in fluid communication with the medicament cartridge is a functional limitation. The piston drive member is fully capable of not moving distally within the housing until after the needle has been placed in fluid communication with the medicament cartridge, as item 44 and 39 can be moved together. Furthermore, the piston could be within item 46, but unthreaded to item 36, while the needle is placed in fluid communication with the medicament cartridge, and then item 44 could be threaded to item 36 after the needle is placed in fluid communication with the medicament cartridge to enable movement of the piston drive member, therefore enabling the piston drive member to not move distally within the housing until after the needle has been placed in fluid communication with the medicament cartridge).
Claims 35-42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hansen (U.S. PG publication 20170014575).
In regard to claim 35,
Hansen discloses a medicament delivery device (see figure 1A-4B, item 100; paragraph [0001]) comprising:
a housing (figure 1B, item 220);
a medicament cartridge (figure 1B, item 600; paragraph [0061]) disposed within the housing such that (i) a distal end of the housing is distal to a distal end of the medicament cartridge (see figure 1B), and (ii) a proximal end of the housing is proximal to a proximal end of the medicament cartridge (see figure 1B), the medicament cartridge comprising (i) a sealing member (figure 1A, item 620) disposed at a distal end of the medicament cartridge (see figure 1A) and (ii) a piston (figure 1A, item 630) disposed within the medicament cartridge (see figure 1A), wherein a medicament is located between the piston and the sealing member (paragraph [0061]);
a needle (figure 1B, item 500) disposed within the housing (see figure 1B), the needle having a distal end and a proximal end (see figure 1B); and
a cover (cap described in paragraph [0058]) removably attached to the medicament delivery device (paragraph [0058]) such that when the cover is attached to the medicament delivery device (i) the medicament cartridge and the needle are prevented from moving relative to one another (paragraph [0060]; the medicament cartridge and the needle are prevented from moving relative to one another since the cap blocks item 350 from being displaced, which blocks item 530 from being released and therefore blocks the release of the medicament cartridge) and (ii) a first portion (portion of the cover that is attached/contacts the housing; paragraph [0060]) of the cover is outward of the housing and can be grabbed by a user (paragraph [0058] and [0085]),
wherein the medicament delivery device is configured such that after the user removes the cover from the medicament delivery device, the medicament cartridge and the needle remain spaced apart from one another (see figure 1A and 1B) until a trigger element (figure 1B, item 380) is actuated which causes the medicament cartridge and the medicament cartridge to move toward one another such that the proximal end of the needle pierces the sealing member of the medicament cartridge and places the needle in fluid communication with the medicament within the medicament cartridge (paragraph [0080]-[0081] and [0090]-[0094]).
In regard to claim 36,
Hansen discloses the medicament delivery device of claim 35, wherein the medicament delivery device is configured such that after the cover has been removed from the medicament delivery device distal movement of the medicament cartridge is allowed (paragraph [0085]-[0094]).
In regard to claim 37,
Hansen discloses the medicament delivery device of claim 35, wherein the medicament delivery device is configured such that after the cover has been removed from the medicament delivery device the medicament cartridge and the needle are allowed to move relative to one another (paragraph [0085]-[0094]).
In regard to claim 38,
Hansen discloses the medicament delivery device of claim 35, wherein the medicament delivery device is configured such that a distally-directed force moves the medicament cartridge toward the needle when the trigger element of the medicament delivery device is actuated (paragraph [0085]-[0094]).
In regard to claim 39,
Hansen discloses the medicament delivery device of claim 38, wherein the medicament delivery device is configured to dispense a medicament from the medicament cartridge into the user when the trigger element of the medicament delivery device is actuated (paragraph [0085]-[0094]).
In regard to claim 40,
Hansen discloses the medicament delivery device of claim 35, comprising a member (figure 1A, item 350) disposed within the housing (see figure 1A) and configured to remain in a first position when the cover is attached to the medicament delivery device to limit distal movement of the medicament cartridge relative to the housing (paragraph [0060] and [0085]-[0094]), the member comprising (i) a sidewall extending substantially parallel to a sidewall of the housing (see figure 1A) and (ii) a distal portion extending radially inward from the sidewall (see figure 1A).
In regard to claim 41,
Hansen discloses the medicament delivery device of claim 40, wherein the cover comprises a second portion (remaining portion of the cap not directly contacting the housing) that is slidably engaged with the member when the cover is attached to the housing to limit distal movement of the medicament cartridge relative to the housing (paragraph [0060]).
In regard to claim 42,
Hansen discloses the medicament delivery device of claim 40, comprising a piston drive member (figure 1A, item 310) disposed within the housing (see figure 1B), the piston drive member having a distal end configured to engage the piston (see figure 2B and 3B) within the medicament cartridge to force the piston in a distal direction relative to the medicament cartridge and expel the medicament from the medicament cartridge through the needle when the needle is in fluid communication with the medicament cartridge (paragraph [0093]-[0094]).
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.
Claims 28, 35-40, 42, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Marshall (U.S. Patent no 6077247) further in view of Kouyoumjian (U.S. PG publication 20120283646).
In regard to claim 28,
Marshall discloses the medicament delivery device of claim 16, wherein the medicament cartridge contains an ingredient (column 1, line 3-14 and column 3, line 4-7), and the ingredient is disposed between the sealing element and the piston (column 1, line 3-14 and column 3, line 4-7).
Marshall is silent as to wherein the medicament cartridge contains the medicament, and the medicament is disposed between the sealing element and the piston.
Kouyoumjian teaches wherein the medicament cartridge (figure 1, item 2) contains the medicament (paragraph [0056]), and the medicament is disposed between the sealing element (figure 1, item 3) and the piston (figure 1, item 4).
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 Marshall to replace the ingredient within the cartridge with a medicament, therefore resulting in the medicament is disposed between the sealing element and the piston, as taught by Kouyoumjian, for the purpose of treating a disease (paragraph [0029]-[0033] of Kouyoumjian).
In regard to claim 35,
Marshall discloses a medicament delivery device (see all of figure 1; Examiner notes the device is construed as a medicament delivery device as it is fully capable of delivering a medicament) comprising:
a housing (figure 1, item 3 and 10, not including item 11);
a medicament cartridge (figure 1, item 1; Examiner notes the cartridge is construed as a medicament cartridge as it is fully capable of containing a medicament; column 3, line 4-7: wherein a single ingredient is included in the cartridge) disposed within the housing (see figure 1) such that (i) a distal end of the housing is distal to a distal end of the medicament cartridge (see figure 1), and (ii) a proximal end of the housing is proximal to a proximal end of the medicament cartridge (see figure 1), the medicament cartridge comprising (i) a sealing member (figure 1, item 23) disposed at a distal end of the medicament cartridge (see figure 1) and (ii) a piston (figure 1, item 24) disposed within the medicament cartridge (see figure 1), wherein an ingredient is located between the piston and the sealing member (see figure 1; column 3, line 4-7: wherein a single ingredient is included in the cartridge);
a needle (figure 1, item 2) disposed within the housing (see figure 1), the needle having a distal end (end opposite item 22) and a proximal end (figure 1, item 22); and
a cover (figure 1, item 18 and 19) removably attached to the medicament delivery device (see figure 3 in which the cover has been removed) such that when the cover is attached to the medicament delivery device (i) the medicament cartridge and the needle are prevented from moving relative to one another (see figure 1; column 2, line 53-65; Examiner notes the medicament cartridge and the needle are prevented from moving relative to one another as the device cannot be operated until the cover is removed) and (ii) a first portion (figure 1, item 18) of the cover is outward of the housing and can be grabbed by a user (see figure 1),
wherein the medicament delivery device is configured such that after the user removes the cover from the medicament delivery device, the medicament cartridge and the needle remain spaced apart from one another (see figure 1) until a trigger element (rear part of item 11 that is accessible through slot 7 as shown in figure 2) is actuated which causes the medicament cartridge and the medicament cartridge to move toward one another such that the proximal end of the needle pierces the sealing member of the medicament cartridge and places the needle in fluid communication with the ingredient within the medicament cartridge (column 2, line 53-65).
Marshall is silent as to wherein a medicament is located between the piston and the sealing member. As a result, Marshall is also silent as to such that the proximal end of the needle pierces the sealing member of the medicament cartridge and places the needle in fluid communication with the medicament within the medicament cartridge.
Kouyoumjian teaches a medicament cartridge (figure 1, item 2; paragraph [0056]), and a medicament is located between the piston (figure 1, item 4) and the sealing member (figure 1, item 3).
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 Marshall to replace the ingredient within the cartridge with a medicament, therefore resulting in a medicament is located between the piston and the sealing member and such that the proximal end of the needle pierces the sealing member of the medicament cartridge and places the needle in fluid communication with the medicament within the medicament cartridge, as taught by Kouyoumjian, for the purpose of treating a disease (paragraph [0029]-[0033] of Kouyoumjian).
In regard to claim 36,
Marshall in view of Kouyoumjian teaches the medicament delivery device of claim 35, wherein the medicament delivery device is configured such that after the cover has been removed from the medicament delivery device distal movement of the medicament cartridge is allowed (column 2, line 53-65 of Marshall).
In regard to claim 37,
Marshall in view of Kouyoumjian teaches the medicament delivery device of claim 35, wherein the medicament delivery device is configured such that after the cover has been removed from the medicament delivery device the medicament cartridge and the needle are allowed to move relative to one another (column 2, line 53-65 of Marshall).
In regard to claim 38,
Marshall in view of Kouyoumjian teaches the medicament delivery device of claim 35, wherein the medicament delivery device is configured such that a distally-directed force moves the medicament cartridge toward the needle when the trigger element of the medicament delivery device is actuated (column 2, line 53-65 of Marshall).
In regard to claim 39,
Marshall in view of Kouyoumjian teaches the medicament delivery device of claim 38, wherein the medicament delivery device is configured to dispense a medicament from the medicament cartridge into the user when the trigger element of the medicament delivery device is actuated (column 2, line 53-65 of Marshall).
In regard to claim 40,
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Marshall in view of Kouyoumjian teaches the medicament delivery device of claim 35, comprising a member (see figure 1 above of Marshall wherein a portion of item 11 forms the member) disposed within the housing (see figure 1 of Marshall) and configured to remain in a first position when the cover is attached to the medicament delivery device to limit distal movement of the medicament cartridge relative to the housing (column 2, line 53-65 of Marshall), the member comprising (i) a sidewall (see figure 1 of Marshall) extending substantially parallel to a sidewall of the housing (see figure 1 of Marshall) and (ii) a distal portion (figure 1, item 14 of Marshall) extending radially inward from the sidewall (see figure 1 of Marshall).
In regard to claim 42,
Marshall in view of Kouyoumjian teaches the medicament delivery device of claim 40, comprising a piston drive member (figure 1, item 20 of Marshall) disposed within the housing (see figure 1 of Marshall), the piston drive member having a distal end configured to engage the piston within the medicament cartridge to force the piston in a distal direction relative to the medicament cartridge and expel the medicament from the medicament cartridge through the needle when the needle is in fluid communication with the medicament cartridge (column 2, line 53-65 of Marshall).
In regard to claim 44,
Marshall in view of Kouyoumjian teaches the medicament delivery device of claim 40, comprising a first part (figure 1, item 21 of Marshall) disposed in the housing (see figure 1 of Marshall), the first part comprising a proximally-extending portion having a proximal end configured to engage a distal neck of the medicament cartridge (see figure 5 of Marshall) to couple distal movement of the medicament cartridge to the first part (see figure 5 of Marshall compared to figure 4 of Marshall), the first part configured to move distally within the housing when forced distally by the medicament cartridge (see figure 5 of Marshall compared to figure 4 of Marshall).
Allowable Subject Matter
Claims 25-26 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
In regard to claim 25,
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 medicament delivery device of claim 16 wherein the removable needle cover comprises a second portion that is slidably engaged with the member when the removable needle cover is inserted into the housing, and the medicament delivery device is configured such that removal of the removable needle cover from the housing causes the second portion of the removable needle cover to disengage from the member to allow the member to be moved relative to the medicament cartridge to place the hollow needle in fluid communication with the medicament in the medicament cartridge.
Marshall (U.S. Patent no 6077247) discloses a removable needle cover (figure 1, item 18 and 19). The medicament delivery device of Marshall is however not configured such that removal of the removable needle cover from the housing causes the second portion of the removable needle cover to disengage from the member to allow the member to be moved relative to the medicament cartridge to place the hollow needle in fluid communication with the medicament in the medicament cartridge.
Dependent claim 26 would be allowable by virtue of being dependent upon allowable claim 25.
Conclusion
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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