DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 22 recites the thermal bridge is a collar disposed between the first and second part of the housing. Claim 22 has been amended to depend on claim 18. Claim 18 depends on claim 17 which states the inner and outer surface are integrally formed with the thermal bridge, 18 recites the outer surface is an outer surface of a housing. This makes the thermal bridge and the housing integral. These appear to be two different embodiments of the device the structure of claims 17/18 shown in Fig. 3 and the structure of claim 22 shown in Fig. 4. It is not clear how a thermal bridge which is formed integrally with the housing can be between housing portions. For the purposes of the examination, it is taken as interpreted in the below rejection.
Claim Rejections - 35 USC § 103
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.
Claim(s) 16-25 and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (US 2010/0305504 A1) as evidenced by Applicant Admitted Prior Art (AAPA).
With regard to claims 16, 17, 23, Wang et al. teach a drug delivery device comprising: an outer surface (Fig. 3 outer surface of 12); a region for receiving a medicament container (Fig. 1, [0030], [0053] adhesive or elastic fit), the region having an inner surface to contact and support a medicament container received therein (Fig. 3 inner surface of 12); and a thermal bridge extending between the inner surface and the outer surface to conduct heat between the inner surface and the outer surface, wherein the thermal bridge has a thermal conductivity of at least 10W/mk ([0031], [0052], material of 12, see the table on Pg. 13 of AAPA listing the thermal conductivity of materials, 12 may be any of the listed materials).
With regard to claims 18 and 19, 12 is taken as a housing.
With regard to claim 20, see Fig. 1 ([0029]), the housing fits around the container, the claim does not recite what the thickness is increased relative to, therefore, the thickness of 12 is taken as increased from zero.
With regard to claim 21, 12 can be separated into first and second parts.
With regard to claim 22, alternatively 113 and 112 are taken as first and second parts of a housing and 12 is formed as collar between (Figs. 1 and 3).
With regard to claims 24 and 25, see Fig. 1 ([0030] adhesive or elastic fit).
With regard to claim 31, Wang et al. teach a method of operating a drug delivery device, the method comprising: placing an outer surface of a drug delivery device in contact with a heat source to heat a medicament within a medicament container of the drug delivery device from a storage temperature to an injection temperature (Fig. 3 outer surface of 12 is placed in contact with 11/112/113 to heat medicament as shown in Fig. 1, [0005], [0025]), the drug delivery device comprising a thermal bridge extending between the medicament container and the outer surface, the thermal bridge having a thermal conductivity equal to or greater than 10W/mk ([0031], [0052], material of 12, see the table on Pg. 13 of AAPA listing the thermal conductivity of materials, 12 may be any of the listed materials).
Claim(s) 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (US 2010/0305504 A1).
With regard to claim 30, Wang et al. teach a system comprising: a heater comprising a heated docking surface (fig. 3 including at least 11, 112, and 113); and a drug delivery device comprising an outer surface, an inner surface, and a thermal bridge extending between the inner surface and the outer surface (Fig. 3 member 12, [0031], [0052], material of 12), wherein the heated docking surface is configured to contact the outer surface of the drug delivery device when the drug delivery device is placed on the heated docking surface (Fig. 3).
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) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2010/0305504 A1) as evidenced by Applicant Admitted Prior Art (AAPA) as applied to claim 25 above.
With regard to claim 26, Wang et al. teach attachment with adhesive ([0053]) but do not disclose the material of the adhesive. However, as Wang teaches using materials which are conductive because the purpose is to heat the medicament container substance it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to select an adhesive with the necessary thermal conductivity it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2010/0305504 A1) as evidenced by Applicant Admitted Prior Art (AAPA) as applied to claim 25 above, and further in view of Janek et al. (US 2006/0189935).
With regard to claim 27, Wang et al. teach a device substantially as claimed but do not disclose the material of the container. However, Janek et al. teach using medical grade materials for syringes which include stainless steel ([0029]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use stainless steel for the medicament container in Wang et al. as Janek et al. teach such is a suitable medical material and AAPA illustrates the thermal conductivity of stainless steel. Further, the container is functionally recited as used with the device and the device of Wang et al. is capable of receipt of a container with such a thermal conductivity.
Claim(s) 28 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2010/0305504 A1) as evidenced by Applicant Admitted Prior Art (AAPA) as applied to claim 16 above, and further in view of Lee et al. (US 2024/0066206 A1).
With regard to claims 28 and 29, Wang et al. teach a device substantially as claimed. Wang et al. do not disclose a thermochromic material. However, Lee et al. teach using a thermochromic material attached to a surface and viewed through a window to indicate the temperature via a change in color from clear to a color of vice versa ([0045], [0046], Figs. 1-19). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a thermochromic indicator on member 12 of Wang et al. to be viewed through a window of the device as this would indicate to the user the temperature to ensure proper use and enhance safety. There are a limited number of options for which surface the sensor would be placed and one of ordinary skill would reasonably select the surface of the bridge. The outer surface necessarily has a color and as the material may turn clear this would signal a correspondence when the desired temperature is reached.
Response to Arguments
Applicant's arguments filed December 18, 2025 have been fully considered but they are not persuasive. As rejected above, the change in dependency to claim 22 has not resolved the issue under 35 U.S.C. 112. Regarding the rejection over Wang, Applicant argues that 12 does not provide an outer surface of the drug delivery device because it is within 11. 11 is not considered as part of the drug delivery device, the outer surface of one structure may be interior to a different structure. The Examiner would also note the embodiment of Fig. 3 is relied upon in Wang not Fig. 6. Applicant argues thermal insulators which are ceramics would have lower thermal conductivity. As listed in cited paragraph [0052] member 12 may be made from materials which also include stainless steel. Regarding claim 30, 12 is part of the drug delivery device upon which the heating components, considered as separate structures, are placed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783