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 .
Response to Amendment
Amendments filed 09/19/2025 have been entered.
Claims 17, 24 and 28 have thereby been amended.
Claims 25 and 31-36 have been cancelled.
Claims 37-39 have been added.
Claims 17-24, 26-30 and 37-39 are being examined in this office action.
Claim Rejections - 35 USC § 102
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 39 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marshall (US 20140236076).
Regarding claim 39, Marshall discloses a drug delivery device (Fig. 1 autoinjector device), the drug delivery device comprising: a housing (Fig. 1: 10’+10”+30) comprising a first thermal coupling surface (surface 10’+10”) arranged and configured to transfer thermal energy (para. [0027]: energy is transferred through 10’+10” to 34); a moveable member moveably coupled to the housing (Fig. 3: trigger button 38+36 and strip 34, movement of 34 seen between Figs. 4 and 3), the moveable member comprising a second thermal coupling surface arranged and configured to transfer thermal energy (bimetallic strip 34); and a thermally controlled member (Fig. 2: thermally sensitive indicator 38+40), which is thermally conductively connected to the first thermal coupling surface and the second thermal coupling surface (Fig. 1: thermally sensitive indicator 38+40 is in physical and therefore thermal connection to 34 and 10’ and 10”), wherein the thermally controlled member is configured to operate in response to thermal energy transferred through the first thermal coupling surface and the second thermal coupling surface (para. [0029], the thermally sensitive indicator changes when the temperatures through it, 34, 10’ and 10” reach a threshold temperature), wherein the drug delivery device is configured to perform a drug delivery operation (para. [0027], last sentence).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 17, 18, 22, 23 and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over by Gibson (US 20190022306) in view of in view of Nessel (US 10369298) in further view of Gonnelli (US 9101706).
Regarding claim 17, Gibson discloses a drug delivery device (Fig. 77: 11010) comprising: a thermal coupling surface (11602) which is arranged and configured to transfer thermal energy (page 64, para. 0628], last two sentences), and a thermally controlled member (11604 & 11606 + connected locking mechanism: page 25, para. [0358], sentences 7-8 and page 64, para. [0631], sentence 4), which is thermally conductively connected to the thermal coupling surface (11036: page 64, para. [0626], last sentence), wherein the thermally controlled member is configured to operate in response to thermal energy transferred through the thermal coupling surface (page 64, para. [0630] second half, and para. [0631] first half), and wherein the drug delivery device is configured to perform a drug delivery operation (page 64, para. [0631] second half), wherein the thermally controlled member is arranged and configured to move in response to thermal energy transferred through the thermal coupling surface (temperature thresholds detected by sensors 11604 & 11606 cause drive mechanism locking mechanism to move in or out of the locking grooves 110A: page 25, para. [0358], sentences 7-8 and page 64, para. [0631], sentence 4); wherein the drug delivery device comprises an activation surface (Fig. 1C: bottom surface 12B + 24), wherein the activation surface is arranged to be contacted by a user to initiate the drug delivery operation of the drug delivery device (page 14, para. [0299], sentences 4-7), but does not explicitly disclose that the thermal coupling surface is accessible on the activation surface, or that the area surrounding the thermal coupling surface has a lower thermal conductivity.
Nessel teaches an analogous drug delivery device that heats the drug/device via the patient’s body heat, wherein the drug delivery device comprises an activation surface (25), wherein the activation surface is arranged to be contacted by a user to initiate the drug delivery operation of the drug delivery device (col. 7, lines 29-31), wherein the thermal coupling surface (24) is accessible on the activation surface (Fig. 1: 24 accessible on 25). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Gibson device by incorporating heat exchanger base taught by Nessel as the thermal coupling surface, in order to heat the drug without additional heating and controller devices, allowing for a simpler, lighter, smaller, and more cost-effective device (col. 1, lines 57-63). However, the Gibson-Nessel device still fails to explicitly disclose that the area surrounding the thermal coupling surface has a lower thermal conductivity than the thermal coupling surface.
Gonnelli teaches an analogous drug delivery device with a thermal coupling surface for conducting heat from the user to the fluid, wherein regions laterally surrounding or adjacent to the thermal coupling surface (Figs. 5 and 6A: thermal coupling surface 226b and the region surrounding/adjacent to 226b being 542&542a) are formed of a material having lower thermal conductivity than the thermal coupling surface (col. 10, lines 38-42: 542a has a lower thermal conductivity than 226b). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Gibson-Nessel device by incorporating this teaching of Gonnelli by making the attachment surface (Nessel: 23) surrounding the thermal coupling surface (Nessel: 24) have a lower thermal conductivity in order to direct the heat transfer at the thermal coupling surface and preserve the adhesive quality of the attachment surface surrounding the thermal coupling surface.
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Regarding claim 18, Gibson in view of Nessel in further view of Gonnelli teaches the drug delivery device of claim 17, as described above, wherein the thermally controlled member is an electrical temperature sensor (Gibson: 11604 & 11606) or an electrical temperature triggerable switch.
Regarding claim 22, Gibson in view of Nessel in further view of Gonnelli teaches the drug delivery device of claim 17, as described above, wherein the drug delivery device comprises a housing (Gibson: 12) and a receptacle (Gibson: 20 and 130), which is provided in the housing or permanently or releasably connected to the housing (Gibson: page 15, para. [0307], sentences 1-2), wherein the receptacle is designed to receive a medicament container (Gibson: 50) or wherein the medicament container is received in the receptacle, and wherein the drug delivery device comprises a drive mechanism (Gibson: 100), which is operable to drive the drug delivery operation, wherein the drive mechanism comprises at least one moveable drive member which is configured to be moved with respect to the housing (Gibson: page 23, para. [0345], sentence 1) in order to deliver medicament from the medicament container through a dispensing opening (Gibson: 252) of the drug delivery device during the drug delivery operation.
Regarding claim 23, Gibson in view of Nessel in further view of Gonnelli teaches the drug delivery device of claim 22, as described above, but fails to explicitly disclose that the thermal coupling surface is conductively connected to the medicament container in the receptacle.
Nessel teaches an analogous drug delivery device that heats the drug/device via the patient’s body heat, wherein the thermal coupling surface (24) is associated with the receptacle of the drug delivery device such that the thermal coupling surface is thermally conductively connected to the medicament container, when the medicament container is arranged in the receptacle (col. 6, line 63 – col. 7, line 5). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the Gibson-Nessel-Gonnelli device by incorporating heat exchanger base taught by Nessel as the thermal coupling surface, in order to heat the drug without additional heating and controller devices, allowing for a simpler, lighter, smaller, and more cost-effective device (col. 1, lines 57-63).
Regarding claim 26, Gibson in view of Nessel in further view of Gonnelli teaches the drug delivery device of claim 17, as described above, wherein the drug delivery device comprises a bearing surface (Gibson: Fig. 1C: bottom surface), which is arranged to contact skin of a user or a patient during and/or before the drug delivery operation (Gibson: page 13, para. [0295]), but fails to explicitly disclose that the thermal coupling surface is accessible on the bearing surface.
Nessel teaches an analogous drug delivery device that heats the drug/device via the patient’s body heat, wherein the drug delivery device comprises a bearing surface (25), which is arranged to contact skin of a user or a patient during and/or before the drug delivery operation (col. 7, lines 29-31), wherein the thermal coupling surface (24) is accessible on the bearing surface (Fig. 1: 24 accessible on 25). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Gibson-Nessel-Gonnelli device by also incorporating heat exchanger base taught by Nessel as the thermal coupling surface, in order to heat the drug without additional heating and controller devices, allowing for a simpler, lighter, smaller, and more cost-effective device (col. 1, lines 57-63).
Regarding claim 27, Gibson in view of Nessel in further view of Gonnelli teaches the drug delivery device of claim 17, as described above, wherein the drug delivery device comprises an electronic control unit (Gibson: 400, 11400), wherein the thermally controlled member is operatively coupled or coupleable to the electronic control unit (Gibson: Fig. 77: 11602 coupled to 11400; page 64, para. [0628], sentence 3) and wherein the drug delivery device is configured such that the electronic control unit permits initiation of the drug delivery operation only if a temperature at the thermal coupling surface is within a predetermined temperature range (Gibson: page 64, para. [0631] second half).
Regarding claim 28, Gibson in view of Nessel in further view of Gonnelli teaches the drug delivery device of claim 17, as described above, wherein the drug delivery device is configured to store and/or transmit data on a temperature at the thermal coupling surface when the drug delivery operation has been initiated and/or while the drug delivery operation is being performed (Gibson: page 64, para. [0631]).
Regarding claim 29, Gibson in view of Nessel in further view of Gonnelli teaches a system comprising the drug delivery device of claim 17 as described above, and an evaluation unit (Gibson: 11400) which is integrated into or operatively coupleable to the drug delivery device (Gibson: Fig. 77: 11400), wherein the drug delivery device is configured to transfer temperature data which is indicative for the temperature at the thermal coupling surface to the evaluation unit (Gibson: page 64, para. [0631], sentence 1).
Regarding claim 30, Gibson in view of Nessel in further view of Gonnelli teaches a method for evaluating a drug delivery device according to claim 17, as described above, comprising comparing a temperature at the thermal coupling surface with a predetermined temperature or temperature range (Gibson: upper and lower temperature limits: page 123, claim 19), the temperature being derived from the thermally controlled member (Gibson: 11604 & 11606) before, during, or after the delivery operation (Gibson: page 64, para. [0630], sentences 2-4).
Claims 19-21, 24, 37 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over by Gibson (US 20190022306) in view of in view of Nessel (US 10369298) in further view of Gonnelli (US 9101706) in further view of Niznik (US 20190053981).
Regarding claim 19, Gibson in view of Nessel in further view of Gonnelli teaches the drug delivery device of claim 17, as described above, but fails to disclose the thermally controlled member as bimetallic.
Niznik teaches drug delivery device that ensures proper drug temperatures and comprises a locking mechanism for the device actuation, wherein the thermally controlled member is a bimetallic member (“popper plate”: page 7, para. [0051], sentences 1-4, and para. [0052]) that in response to reaching a threshold temperature, moves and pushes a mechanical latch associated with the actuation button. It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mechanical locking mechanism of Gibson (page 43, para. [0503], sentences 6-9) by incorporating the bimetallic temperature-responsive “popper plate” taught by Niznik underneath the interlock (Fig. 74: 9054) to release the lock and permit device actuation only when a desired temperature threshold has been reached, in order to create a more simple and more cost-effective means of determining that a threshold temperature has been reached to ensure that the drug is delivered only when it is sufficiently heated to prevent pain to the patient upon injection (Gibson: page 63, para. [0623]), without requiring additional circuitry or controllers for the electrical sensors.
Regarding claim 20, Gibson in view of Nessel in further view of Gonnelli teaches the drug delivery device of claim 17, as described above, but fails to explicitly disclose the specific temperature/temperature range at which the thermally controlled member should operate.
Niznik teaches drug delivery device that ensures proper drug temperatures and comprises a thermally controlled member, wherein the thermally controlled member is designed to operate at a temperature greater than or equal to one of the following values: 22C, 23C, 24C, 25C, 26C, 27C, 28C, 29C, 30C, 31C, 32C, 33C, 34C (page 8, para. [0059], last sentence: temperature thresholds for operation of 15-25°C). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the operating temperatures of the thermally controlled member of Gibson (11604 & 11606) by incorporating the specifically set temperature range for the activation/operation of the thermally controlled member taught by Niznik (page 7, para. [0051], sentence 3), in order to ensure that the specific drug is not administered at an unsafe temperature (Niznik: page 9, para. [0066]; para. [0068], sentence 2).
Regarding claim 21, Gibson in view of Nessel in further view of Gonnelli teaches the drug delivery device of claim 17, as described above, but fails to explicitly disclose the specific temperature/temperature range at which the thermally controlled member should operate.
Niznik teaches drug delivery device that ensures proper drug temperatures and comprises a thermally controlled member, wherein the thermally controlled member is designed to operate at a temperature less than or equal to one of the following values: 44C, 43C, 42C, 41C, 40C, 39C, 38C, 37C, 36C, 35C, 34C, 33C, 32C, 31C, 30C, 29C (page 8, para. [0059], last sentence: temperature thresholds for operation of 15-25°C). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the operating temperatures of the thermally controlled member of Gibson (11604 & 11606) by incorporating the specifically set temperature range for the activation/operation of the thermally controlled member taught by Niznik (page 7, para. [0051], sentence 3), in order to ensure that the specific drug is not administered at an unsafe temperature (Niznik: page 9, para. [0066]; para. [0068], sentence 2).
Regarding claim 24, Gibson in view of Nessel in further view of Gonnelli teaches the drug delivery device of claim 17, as described above, wherein the drug delivery device comprises a mechanical lock that is released (Fig. 75: interlock 9054; page 43, para. [0503], sentences 8-9), wherein the mechanical lock, when established, prevents movement of an element of the device (page 43, para. [0503], sentences 6-7) and, when the mechanical lock is released, the movement of the element is allowed (page 43, para. [0503], sentences 8-9). However, Gibson fails to disclose that this mechanical lock is released in response to the thermal energy supplied to the thermal coupling surface, and instead teaches its response to contact with the patient’s skin.
Niznik teaches an analogous drug delivery device that ensures proper drug temperatures and comprises a locking mechanism for the device actuation. Niznik teaches the locking mechanism as a disk (“popper plate”) that in response to reaching a threshold temperature, moves and pushes a mechanical latch associated with the actuation button (page 7, para. [0051], sentences 1-4, and para. [0052]). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mechanical locking mechanism of Gibson by incorporating the temperature-responsive “popper plate” taught by Niznik underneath the interlock (Fig. 74: 9054) and therefore adjacent to the thermal coupling surface (Fig. 77: 11602) of Gibson, in order to release the lock and permit device actuation only when a desired temperature threshold has been reached in response to thermal energy supplied to the thermal coupling surface, thereby ensuring that the drug is delivered only when it is sufficiently heated to prevent pain to the patient upon injection (Gibson: page 63, para. [0623]) and ensuring the effectiveness of the drug within a temperature range (Niznik: page 8, paras. [0060] and [0061]).
Regarding claim 37, Gibson in view of Nessel in further view of Gonnelli in further view of Niznik teaches the drug delivery device of claim 24, as described above, wherein the element is a trigger member for initiation of the drug delivery operation (Gibson: page 43, para. [0503], sentences 8-9), and wherein the trigger member is a trigger button (Gibson: Figs. 74 and 75: 9010) or a needle shroud.
Regarding claim 38, Gibson in view of Nessel in further view of Gonnelli in further view of Niznik teaches the drug delivery device of claim 24, as described above, wherein the movement is used for the operation the drug delivery device (Gibson: page 43, para. [0503], sentences 8-9).
Response to Arguments
Applicant’s Arguments filed 09/19/2025 regarding the prior art rejection of independent claim 17 has been fully considered and are persuasive. However, in light of the Amendments to claim 17 filed 09/01/2025, a new ground of rejection is made as recited above, in further view of Gonnelli. Independent claim 17 and its depending claims 18, 22, 23 and 26-30 stand rejected by Gibson in view of Nessel in further view of Gonnelli, which in combination teach all the claimed limitations. Dependent claims 19-21, 24, 37 and 38 stand rejected in further view of Niznik.
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 KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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