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 .
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:
Claim 1: wherein each of the first housing electrical contact and the second housing electrical contact is devoid of foam material
Claim Rejections - 35 USC § 112
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.
Claims 12 and 13 are 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. The use of both a power supply protection mechanism and a housing protection mechanism are no used together are not described in claim 1, which is clear in depicting the use of either a housing protection mechanism or a power supply mechanism.
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.
Due to this rejection, claims 12 and 13 are not being treated on their merits at this time.
Claim Rejections - 35 USC § 103
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 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 1-11 and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards et al. 2016/0038266, in view of Pitzen et al. 5,553,675 or Edwards in view of Feldmann et al. 2005/0280393
Regarding claim 1, Edwards discloses a drug administration device configured to administer a drug comprising (Paragraph 0094 states “there is shown an apparatus 10 for communicating, more particularly administering a substance such as medication to an animal”): a housing (gun shaped body, figure 1) wherein the housing comprises a first housing electrical contact and a second housing electrical contact (Since there are two battery terminals 77 within battery pack 74 as depicted in figures 4c and 5a, the portion of handle 21 receiving the battery pack would include two electrical contacts to receive the terminals 77);
a dispensing mechanism configured to dispense the drug, wherein the dispensing mechanism is disposed within the housing (0094 states “The apparatus 10 includes an actuator 14 which is configured to selectively operate the delivery assembly 12 via a control system 100.”);
a drug holder configured to hold the drug (Figure 4a, reservoir 41);
and a removable power supply configured to power the drug administration device (Battery pack 77, figures 4c and 5a), wherein the removable power supply comprises a first power supply electrical contact and a second power supply electrical contact (Terminals 77);
Edwards is silent regarding (I) wherein the housing comprises a housing protection mechanism or the removable power supply comprises a power supply protection mechanism,
(II) wherein: each of the first power supply electrical contact and the second power supply electrical contact includes a sharp element, and each of the first housing electrical contact and the second housing electrical contact is devoid of foam material,
or
the housing includes a hole in the form of a slit of first width, the first power supply electrical contact being disposed on a portion of the removable power supply that has a second width L, the second width being greater than the first width,
(III) wherein: the housing protection mechanism is configured to be in a first configuration configured to protect the first housing electrical contact when the removable power supply is not received within the housing; and a second configuration configured to enable contact between the first housing electrical contact and the first power supply electrical contact and between the second housing electrical contact and the second power supply electrical contact when the removable power supply is received within the housing, the housing protection mechanism is configured to return to the first configuration from the second configuration, due to the material or configuration of the housing protection mechanism, when the removable power supply is removed from the housing;
or
the removable power supply is configured to be in a first configuration configured to protect the second power supply electrical contact when the removable power supply is not received in the housing; and a second configuration configured to enable contact between the first housing electrical contact and the first power supply electrical contract and between the second housing electrical contact and the second power supply electrical contact when the removable power supply is received within the housing, the power supply protection mechanism is configured to return to the first configuration from the second configuration, due to the material or configuration of the power supply protection mechanism, when the removable power supply is removed from the housing.
Pitzen discloses an analogous surgical device that does teach
(I) wherein the removable power supply (Figure 5, battery 30 is removable as stated in column 10 line 31) comprises a power supply protection mechanism,
(II) wherein: the housing (battery receiving portion 48 figure 2) includes a hole (hole 88 figure 17 contains battery terminals 39a) in the form of a slit of first width (Figure 11, battery terminals 39A containing a slit with a width in the form of sides 91 and 92 of a contact member), the first power supply electrical contact (Figure 5, battery contacts 33) being disposed on a portion of the removable power supply that has a second width L (Figure 13 depicts battery contacts 33a with a second width between resilient deflecting members 81 and 82), the second width being greater than the first width (Column 11 line 10 states “The battery terminal 39A is designed to be sandwiched between the flexible, resilient deflecting members 81 and 82”. Since the contact member of terminal 39a can be fit in between battery contact 33a, the width of the battery contact would be greater than the terminal 39a).
(III) wherein: the removable power supply is configured to be in a first configuration configured to protect the second power supply electrical contact when the removable power supply is not received in the housing (Figure 13 depicts a first configuration where the resilient members 81 and 82 would be protecting a power supply electrical contact when the battery is removed as it is in a closed position. Figure 5 depicts the use of two battery contacts 33.);
and a second configuration configured to enable contact between the first housing electrical contact and the first power supply electrical contract and between the second housing electrical contact and the second power supply electrical contact when the removable power supply is received within the housing (Column 11 line 10 states “The battery terminal 39A is designed to be sandwiched between the flexible, resilient deflecting members 81 and 82”.), the power supply protection mechanism is configured to return to the first configuration from the second configuration, due to the material or configuration of the power supply protection mechanism, when the removable power supply is removed from the housing (Once the battery is removed, the resilient materials 81 and 82 would go back to their original configuration as they wouldn’t be pinching battery terminal 39 anymore.).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the battery attachment system of Edwards with the teachings of Pitzen and include a power supply protection mechanism as this would allow for the actual cells within the battery to be protected during a sterilization procedure (Column 8 line 43).
or
Feldmann discloses an analogous attachable power supply system that does teach:
wherein the housing (Housing 34 containing bottom wall 56 in figure 1) comprises a housing protection mechanism (electrical clips 51, 52, 53)
wherein: each of the first power supply electrical contact and the second power supply electrical contact includes a sharp element (output terminal prongs 101, 102, 103, Figure 2), and each of the first housing electrical contact and the second housing electrical contact is devoid of foam material (0046, clips are made of metal)
wherein: the housing protection mechanism is configured to be in a first configuration configured to protect the first housing electrical contact when the removable power supply is not received within the housing (Figure 3);
and a second configuration configured to enable contact between the first housing electrical contact and the first power supply electrical contact and between the second housing electrical contact and the second power supply electrical contact when the removable power supply is received within the housing (Figure 4), the housing protection mechanism is configured to return to the first configuration from the second configuration, due to the material or configuration of the housing protection mechanism, when the removable power supply is removed from the housing (Since the tool is removably attached to the battery, once the battery is removed, the clips would return back to their original configuration);
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Edwards with the teachings of Feldmann and include a housing protection mechanism as this enables electrical contact to activate the battery, and provides a protective barrier to shield the inside of the housing from any unwanted debris if the battery is not connected (figure 3).
Regarding claim 2, modified Edwards discloses the drug administration device of claim 1, wherein the housing comprises the housing protection mechanism (Figure 3 of Feldmann depicts clips 52 and 53 within housing 34.).
Regarding claim 3, modified Edwards discloses the drug administration device of claim 1, wherein the removable power supply comprises the removable power supply protection mechanism (Battery contacts 33A depicted in figure 13 of Pitzen are located on the removable power supply of Battery 30)
Regarding claim 4, modified Edwards discloses the drug administration device of claim 1, wherein the housing protection mechanism in the first configuration forms a seal around the first housing electrical contact (0048 of Feldmann states “The primary battery 30 is connected across the first and second clips 51 and 52”. The clips form a seal protecting this electrical contact.).
Regarding claim 5, modified Edwards discloses the drug administration device of claim 4, wherein the housing protection mechanism in the first configuration forms a seal around the second housing electrical contact (0048 of Feldmann states “The primary battery 30 is connected across the first and second clips 51 and 52”. The clips form a seal protecting this electrical contact.).
Regarding claim 6, modified Edwards discloses teaches the drug administration device of claim 4, wherein the housing protection mechanism comprises a membrane (Clips 51, 52, and 53 act as a membrane), and the first power supply electrical contact is configured to pierce the membrane such that the membrane is in the second configuration when the removable power supply is received within the housing (Figure four of Feldmann).
Regarding claim 7, modified Edwards discloses the drug administration device of claim 5, wherein the first power supply electrical contact and the second power supply electrical contact are each configured to pierce the membrane such that the membrane is in the second configuration when the removable power supply is received within the housing (Figure four of Feldmann).
Regarding claim 8, modified Edwards discloses the drug administration device of claim 1, wherein the power supply protection mechanism in the first configuration forms a seal around the second power supply electrical contact (Figure 13 of Pitzen).
Regarding claim 9, modified Edwards discloses the drug administration device of claim 8, wherein the power supply protection mechanism in the first configuration forms a seal around the first power supply electrical contact (Figure 5 of Pitzen depicts to battery contacts 33, both of these battery contacts would contain the resilient members of 81 and 82 which form a seal around the contact.).
Regarding claim 10, modified Edwards discloses the drug administration device of claim 8, wherein the power supply protection mechanism is a membrane (Resilient members 81 and 82 of Pitzen is a membrane) and the second housing electrical contact is configured to pierce the membrane such that the membrane is in the second configuration when the removable power supply is received within the housing (Column 11 line 10 of Pitzen states “The battery terminal 39A is designed to be sandwiched between the flexible, resilient deflecting members 81 and 82”.).
Regarding claim 11, modified Edwards teaches the drug administration device of claim 9, wherein the first housing electrical contact is configured to pierce the membrane such that the membrane is in the second configuration when the removable power supply is received within the housing (Column 11 line 10 of Pitzen states “The battery terminal 39A is designed to be sandwiched between the flexible, resilient deflecting members 81 and 82”.).
Regarding claim 14, modified Edwards discloses the drug administration device of claim 1, wherein the housing protection mechanism is configured to move from the first configuration to the second configuration by being contacted by the removable power supply when the removable power supply is inserted into the housing (Figure 4 of Feldmann).
Regarding claim 15, modified Edwards discloses the drug administration device of claim 14, wherein the housing protection mechanism is configured to move along a surface of the first housing electrical contact (Figure four of Feldmann depicts the clips moving along a surface of the electrical contact as the “The primary battery 30 is connected across the first and second clips 51 and 52”).
Regarding claim 16, modified Edwards discloses the drug administration device of claim 15, wherein the housing protection mechanism is configured to move along a surface of the second housing electrical contact when the housing protection mechanism moves from the first configuration to the second configuration (Figure four of Feldmann depicts the clips moving along a surface of the electrical contact as the “The primary battery 30 is connected across the first and second clips 51 and 52”).
Regarding claim 17, modified Edwards discloses the drug administration device of claim 1, wherein the power supply protection mechanism is configured to move from the first configuration to the second configuration by being contacted by the housing when the removable power supply is inserted into the housing (Column 11 line 10 of Pitzen states “The battery terminal 39A is designed to be sandwiched between the flexible, resilient deflecting members 81 and 82”.).
Regarding claim 18, modified Edwards discloses the power supply mechanism of claim 17, wherein the power supply protection mechanism is configured to move along a surface of the first power supply electrical contact (Column 11 line 10 of Pitzen states “The battery terminal 39A is designed to be sandwiched between the flexible, resilient deflecting members 81 and 82”. As the sandwiching is taking place, the resilient members move open along the battery contacts of 33A.).
Regarding claim 19, modified Edwards discloses the drug administration device of claim 18, wherein the power supply protection mechanism is configured to move along a surface of the second power supply electrical contact when the power supply protection mechanism moves from the first configuration to the second configuration (Column 11 line 10 of Pitzen states “The battery terminal 39A is designed to be sandwiched between the flexible, resilient deflecting members 81 and 82”. As the sandwiching is taking place, the resilient members move open along the battery contacts of 33A.).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Edwards and Pitzen, further in view of Linforf et al. 2011/0159299.
Regarding claim 20, modified Edwards discloses the drug administration device of claim 1, wherein at least one of the first housing electrical contact, the second housing electrical contact, the first power supply electrical contact, and the second power supply electrical contact is coated with a conductive coating, (Column 10 line 55 of Pitzen states “the contacts 33 are constructed from a flexible, resilient electrically conductive material, such as a material selected from the group comprising copper, brass, bronze, beryllium copper, nickel, stainless steel, aluminum or steel.”), but fails to disclose that the material is hydrophobic. Linforf discloses a type of hydrophobic coating that could be used for batteries and its contacts (Paragraph 0027 states that “FIG. 1 illustrates an exemplary article 20 comprising a substrate 22 and a coating 26. Substrate 22 may comprise a surface 24. Coating 26 may comprise an adhesion promoting layer 28 and a hydrophobic layer 30.” “Examples of article 20 may include batteries and battery contacts.”) It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to modify the material of modified Edwards to include wherein at least one of the first housing electrical contact, the second housing electrical contact, the first power supply electrical contact, and the second power supply electrical contact is coated with a hydrophobic conductive coating, as taught by Linforf, as the battery and its contacts may be susceptible to damage from moisture over time (0003).
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards and Pitzen or Edwards and Feldmann, further in view of Horton et al. 2004/0231667.
Regarding claim 21, modified Edwards discloses the drug administration device of claim 1, but fails to disclose the device comprising at least one sensor located within the housing configured to detect an environmental parameter within the housing; and a processor, wherein the processor is configured to receive data from the at least one sensor and to modify the operation of the drug administration device in response to the data received from the at least one sensor. However, Horton discloses an analogous medicament dispenser that does disclose the device further comprising at least one sensor located within the housing configured to detect an environmental parameter within the housing (Paragraph 0057 states that “The control profile can in aspects be arranged to be responsive to one or more sensors which e.g. sense characteristics of the engagement and drive actions.”); and a processor, wherein the processor is configured to receive data from the at least one sensor and to modify the operation of the drug administration device in response to the data received from the at least one sensor (Paragraph 0084 states that “The electronic data management system has input/output capability and comprises a memory for storage of data; a microprocessor for performing operations on said data; and a transmitter for transmitting a signal relating to the data or the outcome of an operation on the data.”).
It would have been prima facie obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention to modify modified Edwards to include the device further comprising at least one sensor located within the housing configured to detect an environmental parameter within the housing; and a processor, wherein the processor is configured to receive data from the at least one sensor and to modify the operation of the drug administration device in response to the data received from the at least one sensor as doing so would allow for the enablement of drive means in response to sensor data, that is tailored towards the current status of the user (0086).
Regarding claim 22, modified Edwards in view of Horton teaches the drug administration device of claim 21, wherein the at least one sensor comprises a moisture sensor (Paragraph 0079 of Horton states that “In another aspect, the sensor comprises a moisture sensor for sensing the moisture profile associated with the breath of a patient.”). It would have been prima facie obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention to modify modified Edwards to include wherein the at least one sensor comprises a moisture sensor as doing so would allow for the enablement of drive means in response to breath moisture data, that is tailored towards the current status of the user (0086).
Regarding claim 23, modified Edwards in view of Horton teaches the drug administration device of claim 21, wherein the at least one sensor comprises a temperature sensor (Paragraph 0078 of Horton states that “In another aspect, the sensor comprises a temperature sensor for sensing the temperature profile associated with the breath of a patient.”). It would have been prima facie obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the device of modified Edwards to include wherein the at least one sensor comprises a temperature sensor as doing so would allow for the enablement of drive means in response to breath temperature data, that is tailored towards the current status of the user (0086).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Edwards and Pitzen or Edwards and Feldmann, further in view of Edwards2 et al. 2019/0046729.
Regarding claim 24, modified Edwards teaches the drug administration device of claim 1. Neither discloses wherein the drug comprises at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, and paliperidone palmitate. However, Edwards2 discloses an analogous medicament delivery device that does disclose wherein the drug comprises at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, and paliperidone palmitate (Paragraph 0246 states that “For example, anti-tumor necrosis factor agents such as infliximab, etanercept, adalimumab, golimumab, natalizumab, vedolizumab, and certolizumab can be administered using the described auto-injector heroin). It would have been prima facie obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention to modify modified Edwards to include wherein the drug comprises at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, and paliperidone palmitat as these are common macromolecular injectables that can be used to treat various different conditions in patients (0246).
Conclusion
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/ROHAN PATEL/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785