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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a drug delivery device set including a first plunger having a first length, a second plunger having a second length and a trigger mechanism configured to be arranged between the audible and/or tactile indicator and the first plunger when the first plunger is slidably disposed in the housing and arranged between the audible and/or tactile indicator and the second plunger when the second plunger is slidably disposed in the housing” as disclosed in claim 34 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 34-37 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The original disclosure does not recite “A drug delivery device set comprising:” “a first plunger having a first length… a second plunger having a second length” and “a trigger mechanism configured to be (i) arranged between the audible and/or tactile indicator and the first plunger … and the second plunger”. Therefore, there would be many different configurations such as housing somehow is able to accommodate two plungers where the plungers get auto-selected or manually selected by the user using a mechanism or the user is able to insert either a first plunger or a second plunger into the housing as per the user’s needs. Due to lack of instructions, a user will need several experiments to design the device as claimed by the applicant. Therefore, one skilled in the art would not be able to make and use the entire scope of the claimed invention without undue experimentation.
Claims 35-37 being dependent on claim 34 are also rejected.
Claims 17-44 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. The original disclosure does not disclose a plunger having different lengths or selecting a plunger from a group of plungers having different lengths. Additionally, the original disclosure does not disclose a drug delivery device set including a first plunger having a first length, a second plunger having a second length and a trigger mechanism configured to be arranged between the audible and/or tactile indicator and the first plunger when the first plunger is slidably disposed in the housing and arranged between the audible and/or tactile indicator and the second plunger when the second plunger is slidably disposed in the housing. Accordingly, claims 17, 34, 38 and 39 are rejected. The claims 18-33, 35-37, 40-44 being dependent on one of the claims 17, 34, 38 and 39 are also rejected.
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 17-44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 17, the recitation of “a plunger selected from a group of plungers having different lengths” renders the claim indefinite because the original disclosure does not disclose for having a group of plungers having different lengths. Therefore, one of ordinary skill in the art would not be able to determine how much difference among the plunger lengths needs to be in order to achieve a group of plungers having different lengths. Furthermore, the claim does not set a limit for maximum and minimum lengths or nature of lengths or what group of plungers having different lengths comprise. Thus, the claim does not clearly define the scope of the claimed invention. For examination purposes, examiner construes that the selected plunger or plunger present in the injector/device is already selected from a group of plungers having different lengths available in the market or be made using manufacturing process.
Claims 18-33 being dependent on claim 17 are also rejected.
Regarding claim 18, the claim is unclear if “a second drug delivery device” is positively claimed as a part of claimed invention. For examination purposes, examiner construes that “a second drug delivery device” is not positively claimed as a part of claimed invention.
Regarding claim 34, the recitation of a drug delivery device set comprising “a first plunger having a first length … a second plunger having a second length … of the drug” and “a trigger mechanism configured to be (i) arranged between the audible and/or tactile indicator and the first plunger … and the second plunger” renders the claim indefinite because the original disclosure does not provide any description to include more than one plunger. Therefore, one of ordinary skill in the art, would not be able to understand the features of the plunger that would fit in a first plunger and/or a second plunger. Thus, the claim does not clearly define the scope of the claimed invention. For examination purposes, examiner construes that the drug delivery device set comprises a first and second plungers.
Claims 35-37 being dependent on claim 34 are also rejected.
Regarding claim 35, the recitation of “wherein the container is disposed in the drug delivery device” renders the claim indefinite because the claim is unclear if “the container” is claimed positively as a part of the drug delivery device. Claim 34 upon which claim 35 depends upon recites “a housing adapted to receive a container” thereby not positively reciting “a container” as part of claimed invention. For examination purposes, examiner construes “a container” being positively claimed as a part of the claimed invention.
Regarding claim 38, the recitation “disposing a plunger selected from a group of plungers having different lengths in the housing” renders the claim indefinite because the original disclosure does not disclose for having a group of plungers having different lengths. Therefore, one of ordinary skill in the art would not be able to determine how much difference among the plunger lengths needs to be in order to achieve a group of plungers having different lengths. Furthermore, the claim does not set a limit for maximum and minimum lengths or nature of lengths or what group of plungers having different lengths comprise. Thus, the claim does not clearly define the scope of the claimed invention.
Regarding claim 39, the recitation “wherein the plunger is selected from a group of plungers having different lengths” renders the claim indefinite because the original disclosure does not disclose for having a group of plungers having different lengths. Therefore, one of ordinary skill in the art would not be able to determine how much difference among the plunger lengths needs to be in order to achieve a group of plungers having different lengths. Furthermore, the claim does not set a limit for maximum and minimum lengths or nature of lengths or what group of plungers having different lengths comprise. Thus, the claim does not clearly define the scope of the claimed invention.
Claims 40-44 being dependent on claim 39 are also rejected.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 18 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 18 is comparing the drug dose delivered from a claimed drug delivery device with respect to a drug dose delivered by a second drug delivery device wherein the second drug delivery device is not positively claimed. Therefore, if the second drug delivery device has different size with reference to the first drug delivery device, then mere comparison is not further limiting the scope of claimed drug delivery device. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 17-29, 31-33 and 38-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brereton et al. (US 2013/0310757 A1).
Regarding claim 17, Brereton teaches a drug delivery device 1 (figure 1A) comprising:
a housing 7 adapted to receive a container 3 comprising a piston 6 and containing a dose of a drug “M”;
an audible and/or tactile indicator 28 configured to provide an indication to a user at or near an end of a delivery of the drug (paragraph 0183, lines 9-12);
a plunger (integrated structure formed by elements 9, 11 and 17) selected from a group of plungers (all the varying lengths of plungers that could be manufactured to insert inside element 3) having different lengths, each plunger of the group of plungers configured to be slidably disposed in the housing 7 and adapted to drive the piston 6 for delivering the drug; and
a trigger mechanism 31 (figures 26A, 26B) arranged between the audible and/or tactile indicator 28, 21 and the plunger 9, 11, 17, the trigger mechanism 31 (figures 26A, 26B) configured to couple with any plunger of the group of plungers to activate the audible and/or tactile indicator (see figures 14A-14C).
Regarding claim 18, Brereton teaches wherein the dose of the drug is a first dose (dose delivered from element 9) that is different from a second dose delivered by a second drug delivery device comprising a plunger from a group of plungers having a different plunger length compared to the length of the plunger of the drug delivery device (if a drug delivery device with a length of element 9 being smaller than the length of element 9 disclosed by Brereton is used then the element 9 in the second drug delivery device will not be able to travel towards the end of element 3 thereby delivering a second dose which will be less than the first dose).
Regarding claim 19, Brereton teaches further comprising a drive spring 8 preloaded between the housing 7 and the plunger 9, 11, 17 to urge the plunger in a distal direction (paragraph 0158, lines 10-12).
Regarding claim 20, Brereton teaches wherein the trigger mechanism 31 is configured (i) to support the audible and/or tactile indicator 28 in an initial state of the drug delivery device (figure 14A) and during the delivery of the drug (paragraph 0163, lines 12-20) and (ii) to couple with any plunger (if only the length of element 9 is varied by keeping elements 11 and 17 same, plunger of any length would work in the device) of the group of plungers to activate (paragraph 0163, lines 20-31) the audible and/or tactile indicator 28 at or near the end of the delivery of the drug.
Regarding claim 21, Brereton teaches wherein upon activating the audible and/or tactile indicator 28, the audible and/or tactile indicator 28 disengages from a support 30 of the trigger mechanism 31.
Following is the first interpretation of claim 22 under Brereton
Regarding claim 22, Brereton teaches wherein the trigger mechanism 31 comprises at least one structure 28.1, 28.3, 30.1 resiliently abutting the plunger 9, 11, 17.
Following is the rejection of claim 23 under first interpretation of claim 22
Regarding claim 23, Brereton teaches wherein the at least one structure 30.1 protrudes from an indicator holder 30 towards the plunger 9, 11, 17.
Following is the second interpretation of claim 22 under Brereton
Regarding claim 22, Brereton teaches wherein the trigger mechanism 31 comprises at least one structure 30, 28.1, 28.3, 30.1 resiliently abutting the plunger 9, 11, 17.
Following is the rejection of claim 24 under second interpretation of claim 22
Regarding claim 24, Brereton teaches wherein the at least one structure 30 protrudes from the housing 7 towards the plunger.
Following is the rejection of claims 25, 26, 27, 28, 29 under both interpretation of claim 22
Regarding claim 25, Brereton teaches wherein the at least one structure comprises an inclined surface (surfaces of elements 28.3, 30.1).
Regarding claim 26, Brereton teaches wherein the at least one structure comprises a proximal inclined end (see “PE” in figure 14B below) and a distal stepped edge (see “DE” in figure 14B below).
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Regarding claim 27, Brereton teaches wherein the at least one structure 28.3, 30.1 comprises at least one fin or rib (elements 28.3 and 30.1 can be construed as rib or fin).
Regarding claim 28, Brereton teaches wherein each plunger 9, 11, 17 of the group of plungers comprises at least one cut-out (cut-out inside element 17 to accommodate elements 28.1, 28.3, 30 and 30.1) adapted to receive the at least one structure 30, 28.1, 28.3, 30.1 at or near the end of the delivery of the drug.
Regarding claim 29, Brereton teaches wherein the at least one cut-out comprises at least one of a lateral inclined edge or a distal stepped edge (see “D” in figure 14B above).
Regarding claim 31, Brereton teaches further comprising a needle sleeve 2 telescopically (paragraph 0138, lines 14-16) coupled to the housing 7.
Regarding claim 32, Brereton teaches wherein the drug delivery device is an auto-injector or pen-injector (see figure 1A).
Regarding claim 33, Brereton teaches further comprising the container 3 containing the dose of the drug “M”, wherein the container 3 is disposed in the housing 7.
Regarding claim 38, Brereton teaches a method of assembling a drug delivery device 1 (figure 1A), the method comprising:
disposing a container 3 in a housing 7 of the drug delivery device, the container 3 containing a dose of a drug “M”;
disposing a plunger (integrated structure formed by elements 9, 11 and 17) selected from a group of plungers having different lengths (all the varying lengths of plungers that could be manufactured to insert inside element 3) in the housing, each plunger of the group of plungers comprising at least one cut-out (cut-out inside element 17 to accommodate elements 28.1, 28.3, 30 and 30.1) adapted to receive at least one structure 28.1, 28.3, 30, 30.1 at or near an end of a delivery of the drug (paragraph 0163, lines 12-35, “state A until immediately prior to the end of injection with the stopper having almost bottomed out” indicates the structures 28.1, 28.3, 30, 30.1 are staying in the cut-out near the end of the delivery of the drug); and
disposing a trigger mechanism 31 (figures 26A, 26B) in the drug delivery device, the trigger mechanism 31 (figures 26A, 26B) configured to generate, by an audible and/or tactile indicator 28, 7.21 of the drug delivery device, an audible and/or tactile indication for any plunger of the group of plungers (paragraph 0163, lines 20-35, paragraph 0189, lines 4-8).
Regarding claim 39, Brereton teaches a method of delivering a drug from a drug delivery device 1 (figure 1A), the method comprising:
moving (paragraph 0158, lines 10-16) a plunger 9, 11, 17 of the drug delivery device 1 relative to a housing of the drug delivery device 1 to (i) deliver a dose “M” of the drug from a container 3 of the drug delivery device 1 and (ii) generate (paragraph 0163, lines 20-35), by an audible and/or tactile indicator of the drug delivery device, an audible and/or tactile indication 28 at or near an end of the delivery of the dose of the drug,
wherein the plunger 9, 11, 17 is selected from a group of plungers having different lengths, and each plunger of the group of plungers is configured to be slidably disposed in the housing 3 and sized such that the audible and/or tactile indication is generated at or near the end of the delivery of the dose of the drug for any plunger of the group of plungers (paragraph 0163, lines 20-35).
Regarding claim 40, Brereton teaches comprising receiving at least one structure 28.1, 28.3, 30, 30.1 (cutout in element 9 where element 7.21 engages in figure 26B) into at least one cut-out of the plunger at or near the end of the delivery of the drug to generate the audible and/or tactile indication (paragraph 0189, lines 4-8, paragraph 0163, lines 12-35, “state A until immediately prior to the end of injection with the stopper having almost bottomed out” indicates the structures 28.1, 28.3, 30, 30.1 are staying in the cut-out near the end of the delivery of the drug).
Regarding claim 41, Brereton teaches wherein the audible and/or tactile indication 28 provides an indication to a user that the dose of the drug was delivered (paragraph 0163, lines 31-35).
Regarding claim 42, Brereton teaches wherein depressing a needle sleeve 2 telescopically coupled to the housing 7 against an injection site to cause the moving (paragraph 0152, paragraph 0153, lines 1-8, paragraph 0157, lines 1-6, paragraph 0158, lines 10-16, without moving element 2 with respect to element 7, element 9 cannot move since trigger button will not be active and claim does not require the plunger to be activated automatically with pressing a needle sleeve) of the plunger 9, 11, 17 relative to the housing 7 to (i) deliver the dose of the drug “M” and (ii) generate the audible and/or tactile indication (paragraph 0163, lines 31-35).
Regarding claim 43, Brereton teaches comprising firing (paragraph 0163, lines 31-35) or activating the audible and/or tactile indicator 28 to generate the audible and/or tactile indication 28.
Regarding claim 44, Brereton teaches comprising releasing the audible and/or tactile indicator 28 to generate the audible and/or tactile indication (paragraph 0163, lines 31-35).
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.
Claim(s) 30 is rejected under 35 U.S.C. 103 as being unpatentable over Brereton et al. (US 2013/0310757 A1) in view of Bayer et al. (US 2016/0045665 A1).
Regarding claim 30, Brereton discloses the claimed invention substantially as claimed, as set forth above in claim 17. Brereton further discloses wherein the trigger mechanism (figures 26A, 26B) comprises two adjacent structures 7.21 and each plunger 9 of the group of the plungers comprises cutouts (portion of element 9 where element 7.21 gets in contact with element 9 as shown in figure 26B. Brereton is silent regarding each plunger comprises two corresponding adjacent cut-outs adapted to receive the two adjacent structures.
However, Bayer teaches a design of a drive mechanism (figure 20a) comprising an element 66 snapping into element 56a to generate a sound for the purpose of using an alternative configuration to generate an audible sound (paragraph 0184, lines 1-4).
One of ordinary skill in the art would modify the device of Brereton to incorporate cut-out as taught by Bayer by including corresponding cutouts for elements 7.21 of Brereton. Thus, Brereton modified in view of Bayer would result in having each plunger comprises two corresponding adjacent cut-outs adapted to receive the two adjacent structures.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the cutouts of Brereton to incorporate each plunger comprises two corresponding adjacent cut-outs adapted to receive the two adjacent structures as taught by Bayer for the purpose of using an alternative configuration to generate an audible sound (paragraph 0184, lines 1-4).
Conclusion
The rejection of claims 34-37 over prior art is withheld until these claims overcomes the 112 rejections as set forth in the current Office Action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783