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 .
Election/Restrictions
Claims 32-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/2/26.
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 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.
Claims 16-25 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.
As to claim 16, the wording of “the drug selected from a group of drugs having different viscosities” is unclear because it is not apparent whether the applicant is attempting to positively recite multiple drugs and/or if the applicant is attempting to recite a method step. If the latter, a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph (see MPEP 2173.05(p)).
As to claim 17, the wording of “wherein the drive spring is selected from a group of drive springs adapted to the different viscosities” is unclear because it is not apparent whether the applicant is attempting to positively recite multiple drive springs (including drive spring(s) not part of the device) and/or if the applicant is attempting to recite a method step. If the latter, a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph (see MPEP 2173.05(p)).
As to claim 19, the wording of “wherein the plunger is selected from a group of plungers adapted to different volumes of the drug to be delivered” is unclear because it is not apparent whether the applicant is attempting to positively recite multiple drive plungers (including plungers not part of the device) and/or if the applicant is attempting to recite a method step. If the latter, a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph (see MPEP 2173.05(p)).
As to claim 21, the limitation of “a design of the housing is identical for different viscosity liquids of the drug” is unclear as the applicant has not claimed any alternative designs for the housing and has not positively claimed liquids having different viscosities. In other words, it is not clear how claim 21 intends to further limit the device.
As to claim 24, the limitation of “wherein a design of the control spring is identical for different viscosity liquids of the drug” is unclear as the applicant has not claimed any alternative designs for the control spring and has not positively claimed liquids having different viscosities. In other words, it is not clear how claim 24 intends to further limit the device.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 16-18 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson et al. (US 2011/0092915 A1), hereafter “Olson”.
As to claim 16, Olson discloses a drug delivery device (100; see Figs. 1A-9) comprising:
a housing (101, 102) adapted to receive a container (118) comprising a piston (112) and containing a dose of a drug (para 0056, 0063), the drug selected from a group of drugs having different viscosities (as noted in the rejections under 35 U.S.C. § 112 above, this limitation is unclear, however see para 0011, claim 10; it is clear the device can be used with drugs having different viscosities);
a plunger (115) configured to be slidably disposed in the housing and adapted to drive the piston for delivering the drug (para 0063); and
a drive spring (119) configured to drive the plunger for delivering the drug (para 0064).
As to claim 17, Olson discloses the drug delivery device according to claim 16, wherein the drive spring is selected from a group of drive springs adapted to the different viscosities (as noted in the rejections under 35 U.S.C. § 112 above, this limitation is unclear, however see para 0011, claim 10; it is clear the device can be adjusted for use with drugs having different viscosities).
As to claim 18, Olson discloses the drug delivery device according to claim 17, wherein the drive springs of the group of drive springs have different forces (see para 0011, claim 10; it is clear parts of the device can be chosen, including the biasing force/spring constant of the spring, for use with drugs having different viscosities).
As to claim 21, Olson discloses the drug delivery device according to claim 16, wherein a design of the housing is identical for different viscosity liquids of the drug (Olson makes no mention of changing a design of its housing, and only mentions changing the force of the biasing spring).
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 of this title, 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) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Wozencroft (US 2013/0310746 A1).
As to claims 19-20, Olson discloses the drug delivery device according to claim 16 as described above, but does not expressly recite wherein the plunger is selected from a group of plungers adapted to different volumes of the drug to be delivered, or wherein the plungers of the group of plungers have different lengths.
Wozencroft teaches “the length of the drive plunger, the length of the drive plunger having been selected from a range of plungers of different length according to the fill volume of the syringe or cartridge” (para 0010; also see claim 6).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the plunger of Olson from a group of plungers adapted to different volumes of the drug to be delivered, wherein the plungers of the group of plungers have different lengths.
One would have been motivated to do so based off of Wozencroft, for the motivation of using the proper plunger for the fill volume of the cartridge/syringe (see para 0010 and claim 6 of Wozencroft).
Claim(s) 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Wilmot et al. (US 2012/0101475 A1), hereafter “Wilmot”).
As to claim 22, Olson discloses the drug delivery device according to claim 16 as described above, further comprising a control spring (114), wherein the control spring is grounded on the housing (see Figs. 4, 7-9).
Olson does not expressly recite that the control spring is weaker than the drive spring.
Wilmot teaches a control spring (153) that is weaker than a drive spring (530) (see para 0131). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Olson such that the control spring is weaker than the drive spring. One would have been motivated to do so in order to ensure that the control spring does not affect other operations of the device (including activation of the device and delivery of the drug) (see para 0124, 0131 of Wilmot).
As to claim 23, Olson in view of Wilmot teaches the drug delivery device according to claim 22 as described above. Olson further discloses a needle shroud (108) configured to be slidably disposed within the housing (slidably disposed within lower housing 102), wherein the needle shroud is biased relative to the housing by the control spring (see Figs. 7-9, para 0058, 0060, 0068 of Olson).
As to claim 24, Olson in view of Wilmot teaches the drug delivery device according to claim 23 as described above. Olson further discloses wherein a design of the control spring is identical for different viscosity liquids of the drug (Olson makes mention of changing a design of its control spring, including for different viscosity liquids of the drug).
As to claim 25, Olson in view of Wilmot teaches the drug delivery device according to claim 23 as described above. Olson further discloses wherein the container comprises a needle (110); wherein the needle shroud (108) is configured to have an extended position in which the needle is protected by the needle shroud (see Figs. 1C, 2C, 9); and wherein the needle shroud is configured to have at least one retracted position in which the needle extends distally from the needle shroud (see Figs. 1D-2B, 7, 8).
Allowable Subject Matter
Claims 26-31 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 26, the closest art of record appears to be Olson (cited above), Wozencroft (cited above), Millet et al. (US 4,015,709), and Sims et al. (US 5,722,956). However, none of the art of record appears to teach/make obvious all the limitations of:
A drug delivery device set comprising:
a first housing adapted to receive a first container comprising a first piston and containing a first drug of a first viscosity;
a second housing adapted to receive a second container comprising a second piston and containing a second drug of a second viscosity,
wherein the first viscosity is different than the second viscosity;
a first plunger having a first length, the first plunger configured to be slidably disposed in the first housing and adapted to drive the first piston for delivering the first drug of the first viscosity;
a second plunger having a second length, the second plunger configured to be slidably disposed in the second housing and adapted to drive the second piston for delivering the second drug of the second viscosity; a first drive spring configured to drive the first plunger for delivering the first drug of the first viscosity; and
a second drive spring configured to drive the second plunger for delivering the second drug of the second viscosity;
wherein the first drive spring has a first drive force different from a second drive force of the second drive spring, and
wherein a design of the first housing is identical to a design of the second housing.
in combination.
Claims 27-31 depend from claim 26.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James D Ponton/Primary Examiner, Art Unit 3783
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