Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Reissue Applications
Applicant is reminded of the continuing obligation under 37 CFR § 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which US Pat. No. 10,188,788 (“the ‘788 patent”) is or was involved. These proceedings would include interferences, reissues, reexaminations and litigations.
Applicant is further reminded of the continuing obligation under 37 CFR § 1.56 to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Amendment to Specification
As per 37 CFR 1.177,
The Office may reissue a patent as multiple reissue patents. If applicant files more than one application for the reissue of a single patent, each such application must contain or be amended to contain in the first sentence of the specification a notice stating that more than one reissue application has been filed and identifying each of the reissue applications by relationship, application number and filing date. The Office may correct by certificate of correction under § 1.322 any reissue patent resulting from an application to which this paragraph applies that does not contain the required notice. (emphasis added)
Since this reissue application is a continuing reissue application from reissue application 17/161,330 which has already issued as RE49848, an amendment to the specification must be filed in this reissue application stating in the first sentence that “…more than one reissue application has been filed…” This amendment should be filed with the next correspondence.
35 U.S.C. 251
Claims 1, 3-6, 8-9, 14-15, 21, 24-30 and 32-35 are rejected under 35 USC 251 in that the reissue application is not correcting an error in the original patent, because original claims 1-32 would be superseded by the reissuance of claims 1-32 in RE49848. In the instant reissue application, claims 1-32 should be indicated as cancelled since they have issued in RE49848 and any amended original claim or new claim should be numbered starting with claim 33.
Claims 1, 3-6, 8-9, 14-15, 21, 24-30 and 32-35 are rejected as being based upon a defective reissue oath/declaration under 35 U.S.C. 251 as set forth below. See 37 CFR 1.175. The reissue oath/declaration filed with this application on 02/26/2024 includes the same error statement that was relied upon in reissue application #17/161,330 and is improper because it fails to identify a new error being corrected by this continuation reissue application. See 37 CFR 1.175 and MPEP § 1414 II (D)(1). The error statement must be a new error statement supporting a continuation reissue since the original error from reissue application #17/161,330 is considered to have been corrected in the issuance of the previous reissue application (RE49848). As set forth in MPEP § 1414 II (D)(1),
Where a continuation reissue application is filed with a copy of the reissue oath/declaration from the parent reissue application, and the parent reissue application is not to be abandoned, the reissue oath/declaration should be accepted by the Office of Patent Application Processing (OPAP) without further evaluation, because it is an oath/declaration, albeit improper under 35 U.S.C. 251. The examiner should, however, reject the claims of the continuation reissue application under 35 U.S.C. 251 as being based on an oath/declaration that does not identify an error being corrected by the continuation reissue application, and should require a new oath/declaration that identifies a new error or a statement explaining compliance with 37 CFR 1.175(f)(2) if appropriate. If the same error corrected in the parent is also being corrected in the continuation reissue application, but the error is being corrected in a different way, a statement is needed to explain compliance with 37 CFR 1.175(f)(2) for a reissue application filed on or after September 16, 2012. For these applications, a petition under 37 CFR 1.183 is not needed. For a reissue application filed before September 16, 2012, a petition under 37 CFR 1.183 will be needed to waive pre-AIA 37 CFR 1.175(e) in order to rely on the same error identified in the parent but being corrected in a different way. See 37 CFR 1.175(f)(2) for reissue applications filed on or after September 16, 2012, and pre-AIA 37 CFR 1.175(e) for reissue applications filed before September 16, 2012. One of form paragraphs 14.01.01, 14.01.02, or 14.01.03 may be used. (emphasis added)
Applicant must provide a new signed Declaration with new error statement or a statement in compliance with 37 CFR 1.175(f)(2) explaining how the error is being corrected in a different way. Applicant is also reminded that the error cannot be based on surrendered subject matter from the original patent application.
Recapture
Claims 1, 3-6, 8-9, 14-15, 21, 24-30 and 32-35 are rejected under 35 U.S.C. 251 as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based. See Greenliant Systems, Inc. et al v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Shahram Mostafazadeh and Joseph O. Smith, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984). A broadening aspect is present in the reissue which was not present in the application for patent. The record of the application for the patent shows that the broadening aspect (in the reissue) relates to claimed subject matter that applicant previously surrendered during the prosecution of the application. Accordingly, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claim subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
As stated in M.P.E.P. § 1412.02,
In Clement, 131 F.3d at 1468-70, 45 USPQ2d at 1164-65, the Court of Appeals for the Federal Circuit set forth a three step test for recapture analysis. In North American Container, 415 F.3d at 1349, 75 USPQ2d at 1556, the court restated this test as follows:
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We apply the recapture rule as a three-step process:
(1) first, we determine whether, and in what respect, the reissue claims are broader in scope than the original patent claims;
(2) next, we determine whether the broader aspects of the reissue claims relate to subject matter surrendered in the original prosecution; and
(3) finally, we determine whether the reissue claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule.
In North American Container, the court cited Pannu, 258 F.3d at 1371, 59 USPQ2d at 1600; Hester, 142 F.3d at 1482-83, 46 USPQ2d at 1649-50; and Clement, 131 F.3d at 1468, 45 USPQ2d at 1164-65 as cases that lead to, and explain the language in, the North American Container recapture test.
Step 1: Amended claim 1 is broader than original patent claim 1. Amended claim 1 does not include the claim limitations as identified below which were part of original patent claim 1.
Transdermal delivery:
“system for trans-dermal delivery of a dose of a medicament”…”a trans-dermal element for delivering the dose of the medicament to the patient;”
Delivery device:
a reservoir “for holding the medicament to be delivered;”
a control unit “for controlling the transformation of external energy transferred from the hand-held drive device to the delivery device into a pumping force and for allowing a specific dose of the medicament to be pumped when the dose is requested, the control unit comprising one or more rotors and/or one or more axial elements for transforming rotational and/or axial force into the pumping force;”
“at least one safe-lock mechanism for preventing mechanical action to cause rotation of the at least one or more rotors and/or movement of the more or more axial pump elements thereby preventing passage of the medicament from the reservoir to the trans-dermal injection element unless a dose is requested;”
Separate hand-held drive device:
“a separate hand-held drive device”…” being configured to be placed temporarily in proximity to the delivery device when a dose of medicament is required, the hand-held drive device comprising an activation unit for activating the control unit of the delivery device”
“the activation unit comprising at least one unlocking element to provide energy to the control unit of the delivery device for unlocking the at least one safe-lock mechanism and a drive unit to provide energy for any of the one or more rotors and/or one or more axial pump elements of the control unit, only when the separate hand-held drive device is in proximity to the delivery portion;”
the “hand-held drive device comprises a sensor capable of detecting the amount of energy being transferred and/or transformed into pumping force.”
Therefore step 1 of the three-step test is met for claims 1, 3-6, 8-9, 14-15, 21, 24-30 and 32-35.
Step 2: the first sub-step
The first sub-step is to determine whether the applicant surrendered any subject matter in the prosecution of the original application. MPEP § 1412.02 defines surrendered subject matter as a claim limitation that was originally relied upon by the applicant in the original prosecution to overcome the prior art. In the prosecution of US Application 13/139,843 (“the ‘843 application”), applicant defined the claims over the prior art and surrendered subject matter. As per MPEP 1412.02, a Surrender Generating Limitation is defined as,
An SGL is a "limitation" presented, argued, or stated to make the claims patentable (in the original application) and "generates" the surrender of claimed subject matter. An SGL or surrendered subject matter can be created by presentation of new/amended claims to define the invention over the art or an argument/statement by applicant that a limitation of the claim(s) (including a limitation in an original claim) defines the invention over the art. A patent owner (reissue applicant) is bound by the argument that applicant relied upon to overcome an art rejection in the original application for the patent to be reissued, regardless of whether the Office adopted the argument in allowing the claims. Greenliant Systems, Inc. v. Xicor LLC, 692 F.3d 1261, 1271, 103 USPQ2d 1951, 1958 (Fed. Cir. 2012). An SGL or surrendered subject matter can also be created by presentation of new/amended claims or an argument/statement to obviate a rejection based on other grounds. In re McDonald, 43 F.4th 1340, 1348, 2022 USPQ2d 745 (Fed. Cir. 2022).
In the claim amendments and response filed 04/03/2017, Applicant added claim limitations to “a delivery device and a separate hand-held drive device,” further defined the control unit “for controlling the transformation of” energy “transferred from the hand-held drive device” to the delivery device into a pumping force and “for allowing a specific” dose of medicament to be pumped,” and added “only when the separate hand-held drive unit is in close unplugged proximity to the delivery device.” Applicant then argued,
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As provided above, applicant relied upon the claiming of a separate hand-held device from the delivery device being placed in close proximity to the delivery device to define over the prior art of record.
In the claim amendments and response filed 10/13/2017, applicant made minor amendments to the claims. However, applicant filed arguments contrasting the claims to the prior art and argued that the delivery device receives wireless information from the hand-held controller allowing for delivery of the medicament. Additionally, applicant argued that this involves the transfer of information and not energy. Further, applicant contrasted that the prior art, Flaherty, “does not disclose, teach or suggest a safety feature involving interactions between the hand-held and the delivery device” and that Brand “fails to disclose, teach or suggest the presently claimed invention. In Brand there is no security feature (corresponding to the claimed safe-lock mechanism) that prevents the rotor to rotate without the hand-held so that the delivery device could rotation if exposed to environmental situations like strong magnetic fields.” See the ‘843 Application, 10/13/2017 Response, p. 8.
In the claim amendments and response filed 11/21/2017, applicant added the claim limitation of “wherein the hand-held drive device comprises a sensor capable of detecting the amount of energy being transferred and/or transformed into pumping force.” Applicant then argued again that the delivery device receives wireless information from the hand-held controller allowing for delivery of the medicament. Applicant also argued that the prior art, Flaherty, “describes the condition of the delivery device itself rather than the interaction between hand-held and delivery system. In fact, the delivery device in Flaherty has a vent that prevents injection when the delivery device is not fully assembled [0101] or [0103] when the components of the delivery device are not properly attached. In addition, Flaherty does not disclose, teach or suggest a safety feature involving interactions between the hand-held and the delivery device. Brand likewise fails to disclose, teach or suggest the present claimed invention. In Brand there is no security feature (corresponding to the claimed safe-lock mechanism) that prevents the rotor to rotate without the hand-held so that the delivery device could rotate if exposed to environmental situations like strong magnetic fields.” See the ‘843 Application, 11/21/2017 Response, p. 8.
In the response filed 07/05/2018, applicant argued the rejection of the claims over the prior art. Specifically, applicant stated on pages 8-9,
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In an interview summary mailed 10/29/2018, it was noted that “[a]pplicant also proposed additional amendment to claims 36 and 54 to explicitly require that the at least one safe-lock mechanism block mechanical operation so as to distinguish the claimed invention over the authentication feature of Hood.”
Step 2: second sub-step
The second sub-step is to determine whether any of the broadening of the reissue claims is in the area of the surrendered subject matter. The examiner must analyze all of the broadening aspects of the reissue claims to determine if any of the omitted/broadened limitations are directed to limitations relied upon by Applicant in the original application to make the claims allowable over the art.
Transdermal delivery:
Reliance by Applicant in original prosecution
“system for trans-dermal delivery of a dose of a medicament”
None
”a trans-dermal element for delivering the dose of the medicament to the patient;”
None
Delivery device:
a reservoir “for holding the medicament to be delivered;”
None
a control unit “for controlling the transformation of external energy transferred from the hand-held drive device to the delivery device into a pumping force and for allowing a specific dose of the medicament to be pumped when the dose is requested, the control unit comprising one or more rotors and/or one or more axial elements for transforming rotational and/or axial force into the pumping force;”
Relied upon in 04/03/2017; 10/13/2017; 11/21/2017; 07/05/2018 amendments and responses
“at least one safe-lock mechanism for preventing mechanical action to cause rotation of the at least one or more rotors and/or movement of the more or more axial pump elements thereby preventing passage of the medicament from the reservoir to the trans-dermal injection element unless a dose is requested;”
Relied upon in 10/13/2017; 11/21/2017; 07/05/2018 amendments and responses and 10/29/2018 interview summary
Separate hand-held drive device:
“a separate hand-held drive device”…” being configured to be placed temporarily in proximity to the delivery device when a dose of medicament is required, the hand-held drive device comprising an activation unit for activating the control unit of the delivery device”
Relied upon in 04/03/2017; 10/13/2017; 11/21/2017; 07/05/2018 amendments and responses
“the activation unit comprising at least one unlocking element to provide energy to the control unit of the delivery device for unlocking the at least one safe-lock mechanism and a drive unit to provide energy for any of the one or more rotors and/or one or more axial pump elements of the control unit, only when the separate hand-held drive device is in proximity to the delivery portion;”
Relied upon in 04/03/2017; 10/13/2017; 11/21/2017; 07/05/2018 amendments and responses
the “hand-held drive device comprises a sensor capable of detecting the amount of energy being transferred and/or transformed into pumping force.”
Relied upon in 04/03/2017; 10/13/2017; 11/21/2017; 07/05/2018 amendments and responses
The claim language removed from claims as detailed above which resulted in the broadening of the claims is the exact claim language or related claim language of the surrendered subject matter by applicant.
Therefore, step 2 of the three-step test is met for claims 1, 3-6, 8-9, 14-15, 21, 24-30 and 32-35.
Step 3: It is impermissible recapture for a reissue claim to be as broad as, or broader in scope than any claim that was canceled or amended in the original prosecution to define over the art. Claim scope that was canceled or amended is deemed surrendered and therefore barred from reissue. Clement, 131 F.3d at 1470, 45 USPQ2d at 1165. It must be determined whether the reissue claim omits or broadens any limitation that was added or argued during the original prosecution to overcome an art rejection. Such an omission in a reissue claim, even if it is accompanied by other limitations making the reissue claim narrower than the patent claim in other aspects, is impermissible recapture. Pannu, 258 F.3d at 1371-72, 59 USPQ2d at 1600. In any broadening reissue application, the examiner will determine, on a claim-by-claim basis, whether the broadening in the reissue application claim(s) relates to subject matter that was surrendered during the examination of the patent for which reissue is requested) by an amendment narrowing claim scope in order to overcome a rejection and/or argument relying on a claim limitation in order to overcome a rejection.
Broadened Subject Matter
Narrowing Amendment
Does or Does Not Invoke Recapture
Transdermal delivery:
“system for trans-dermal delivery of a dose of a medicament”
None
Not relied upon to overcome the prior art in the original prosecution; therefore, not an SGL and does not invoke recapture.
”a trans-dermal element for delivering the dose of the medicament to the patient;”
None
Not relied upon to overcome the prior art in the original prosecution; therefore, not an SGL and does not invoke recapture.
Delivery device:
a reservoir “for holding the medicament to be delivered;”
None
Not relied upon to overcome the prior art in the original prosecution; therefore, not an SGL and does not invoke recapture.
a control unit “for controlling the transformation of external energy transferred from the hand-held drive device to the delivery device into a pumping force and for allowing a specific dose of the medicament to be pumped when the dose is requested, the control unit comprising one or more rotors and/or one or more axial elements for transforming rotational and/or axial force into the pumping force;”
a control unit configured to control operation of the pump … configured to be activated responsive to a relative location of the drive portion
Relied upon in 04/03/2017; 10/13/2017; 11/21/2017; 07/05/2018 amendments and responses. Invokes impermissible recapture in part. See below.
“at least one safe-lock mechanism for preventing mechanical action to cause rotation of the at least one or more rotors and/or movement of the more or more axial pump elements thereby preventing passage of the medicament from the reservoir to the trans-dermal injection element unless a dose is requested;”
a protrusion configured to prevent formation of a fluidic connection between the at least one reservoir and the injection needle when said delivery portion is separated from a drive portion
Separate hand-held drive device:
“a separate hand-held drive device”…” being configured to be placed temporarily in proximity to the delivery device when a dose of medicament is required, the hand-held drive device comprising an activation unit for activating the control unit of the delivery device”
Completely eliminated.
Relied upon in 04/03/2017; 10/13/2017; 11/21/2017; 07/05/2018 amendments and responses; therefore, meets step 3 and is impermissible recapture.
“the activation unit comprising at least one unlocking element to provide energy to the control unit of the delivery device for unlocking the at least one safe-lock mechanism and a drive unit to provide energy for any of the one or more rotors and/or one or more axial pump elements of the control unit, only when the separate hand-held drive device is in proximity to the delivery portion;”
Completely eliminated.
Relied upon in 04/03/2017; 10/13/2017; 11/21/2017; 07/05/2018 amendments and responses; therefore, meets step 3 and is impermissible recapture.
the “hand-held drive device comprises a sensor capable of detecting the amount of energy being transferred and/or transformed into pumping force.”
Completely eliminated.
Relied upon in 04/03/2017; 10/13/2017; 11/21/2017; 07/05/2018 amendments and responses; therefore, meets step 3 and is impermissible recapture.
Claims 1, 3-6, 8-9, 14-15, 21, 24-30 and 32-35 entirely eliminate the surrendered subject matter that includes:
“a separate hand-held drive device”…” being configured to be placed temporarily in proximity to the delivery device when a dose of medicament is required, the hand-held drive device comprising an activation unit for activating the control unit of the delivery device”
“the activation unit comprising at least one unlocking element to provide energy to the control unit of the delivery device for unlocking the at least one safe-lock mechanism and a drive unit to provide energy for any of the one or more rotors and/or one or more axial pump elements of the control unit, only when the separate hand-held drive device is in proximity to the delivery portion;” and
the “hand-held drive device comprises a sensor capable of detecting the amount of energy being transferred and/or transformed into pumping force.”
Applicant specifically argued that the prior art did not disclose these limitations, see Step 2: first sub-step above. Therefore, applicant is not permitted to remove these limitations without invoking impermissible recapture.
Claims 1, 3-6, 8-9, 14-15, 21, 24-30 and 32-35 do not entirely eliminate the surrendered subject matter that includes:
a control unit “for controlling the transformation of external energy transferred from the hand-held drive device to the delivery device into a pumping force and for allowing a specific dose of the medicament to be pumped when the dose is requested, the control unit comprising one or more rotors and/or one or more axial elements for transforming rotational and/or axial force into the pumping force;” and
“at least one safe-lock mechanism for preventing mechanical action to cause rotation of the at least one or more rotors and/or movement of the more or more axial pump elements thereby preventing passage of the medicament from the reservoir to the trans-dermal injection element unless a dose is requested.”
In the 04/03/2017 response, applicant added the claim language of “for controlling the transformation of energy transferred from the hand-held drive device” and “for allowing a specific dose of medicament to be pumped” to distinguish over Flaherty which uses a remote command unit rather than the separate hand-held drive device when in close proximity to the control unit to achieve these functions. This limitation was also discussed in the 07/05/2018 response, see above. Therefore, while the claim limitation now includes a control unit configured to control operation of the pump … configured to be activated responsive to a relative location of the drive portion; applicant did rely upon the claim limitations of “for controlling the transformation of energy transferred from the hand-held drive device…for allowing a specific dose of medicament to be pumped;” therefore, these limitations cannot be eliminated from the claims without invoking impermissible recapture.
In the 04/03/2017 and 10/13/2017 responses, applicant amended the claim language specific to the at least one safe-lock mechanism and argued in the 10/13/2017 response that Flaherty does not disclose, teach or suggest a safety feature involving interactions between the hand-held and the delivery device and further that there is no safe-lock mechanism that “prevents the rotor to rotate without the hand-held so that the delivery device could rotate if exposed to environmental situations like strong magnetic fields.” See the 10/13/2017 response p. 8. Further, in the 07/05/2018 response on pages 8-9, applicant discussed how the prior art does not teach the control element prevents mechanical action of the rotors or axial pump.
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Therefore, while the claim limitation now includes a control unit configured to control operation of the pump … configured to be activated responsive to a relative location of the drive portion; applicant did rely upon the claim limitations of “the control unit comprising one or more rotors and/or one or more axial elements for transforming rotational and/or axial force into the pumping force;” therefore, these limitations cannot be eliminated from the claims without invoking impermissible recapture.
As included in the chart above in Step 2: the second sub-set, applicant argued the limitation of “at least one safe-lock mechanism for preventing mechanical action to cause rotation of the at least one or more rotors and/or movement of the more or more axial pump elements thereby preventing passage of the medicament from the reservoir to the trans-dermal injection element unless a dose is requested” in the responses filed 10/13/2017; 11/21/2017; 07/05/2018. Specifically, applicant contrasted that the prior art, Flaherty, “does not disclose, teach or suggest a safety feature involving interactions between the hand-held and the delivery device” and that Brand “fails to disclose, teach or suggest the presently claimed invention. In Brand there is no security feature (corresponding to the claimed safe-lock mechanism) that prevents the rotor to rotate without the hand-held so that the delivery device could rotation if exposed to environmental situations like strong magnetic fields.” See the ‘843 Application, 10/13/2017 Response, p. 8 and the 11/21/2017 Response, p. 8.
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In an interview summary mailed 10/29/2018, it was noted that “[a]pplicant also proposed additional amendment to claims 36 and 54 to explicitly require that the at least one safe-lock mechanism block mechanical operation so as to distinguish the claimed invention over the authentication feature of Hood.”
Therefore, while the claim limitation now includes a protrusion configured to prevent formation of a fluidic connection between the at least one reservoir and the injection needle when said delivery portion is separated from a drive portion; applicant did rely upon more limitations from the original claim language to include “for preventing mechanical action to cause rotation of the at least one or more rotors and/or movement of the more or more axial pump elements unless a dose is requested;” therefore, these limitations cannot be eliminated from the claims without invoking impermissible recapture.
Therefore, step 3 of the three-step test is met for claims 1, 3-6, 8-9, 14-15, 21, 24-30 and 32-35.
Claims 1, 3-6, 8-9, 14-15, 21, 24-30 and 32-35 are rejected under 35 U.S.C. 251 as indicated above.
Claim Rejections - 35 USC § 251
Original Patent
The following is a quotation of the first paragraph of 35 U.S.C. 251:
(a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.
MPEP 1412.01 states that the reissue claims must be for the same invention as that disclosed as being the invention of the original patent. MPEP 1412.01 further provides guidelines for determining whether the reissue claims are "for the invention disclosed in the original patent" as:
(A) the claims presented in the reissue application are described in the original patent specification and enabled by the original patent specification such that 35 U.S.C. 112, first paragraph is satisfied; and
(B) nothing in the original patent specification indicates an intent not to claim the subject matter of the claims presented in the reissue application.
The presence of some disclosure (description and enablement) in the original patent should evidence that applicant intended to claim or that applicant considered the material now claimed to be his or her invention.
Further, the Federal Circuit addressed the “original patent” requirement of 35 USC 251 in Antares Pharma, Inc. v. Medac Pharma Inc. and Medac GMBH, 771 F.3d 1354, 112 USPQ2d 1865 (Fed. Cir. 2014). In Antares the reissue claims covered embodiments of injection devices (not restricted to jet-injection devices) which the Applicant admitted was a different invention from what was originally claimed. Id. at 1356. The Federal Circuit adopted the Supreme Court's explanation of the “same invention” requirement as “if the original patent specification fully describes the claimed inventions, but not if the broader claims ‘are [] merely suggested or indicated in the original specification’ ”. Id. at 1359. The Federal Circuit further stated that although wording in 35 USC 251 was changed from “same invention” to “original patent” no change in substance was intended. Id. at 1360. Additionally, the Federal Circuit applied the Industrial Chemicals standard for 35 USC 251 emphasizing “’it is not enough that an invention might have been claimed in the original patent because it was suggested or indicated in the specification.’ 315 U.S. at 676. Rather, the specification must clearly and unequivocally disclose the newly claimed invention as a separate invention. Id.”
Based on Antares a review of the specification is necessary to determine whether the original specification adequately discloses the invention of the reissue claims. Like in Antares, the specification consistently sets forth that the invention is a system for trans-dermal delivery that includes both a delivery device and a separate hand held drive device. See Abstract, General Description, and Detailed Description. Consistent with Antares, the specification does not disclose a fluid delivery device comprising a delivery portion and a drive portion.
Therefore, claims 1, 3-6, 8-9, 14-15, 21, 24-30 and 32-35, which are directed to a fluid delivery device comprising a delivery portion and a drive portion do not satisfy the “original patent” requirement.
Claims 1, 3-6, 8-9, 14-15, 21, 24-30 and 32-35 are rejected under 35 USC 251 for not claiming subject matter directed to the invention disclosed in the original patent.
Claim Objections
Claim 14 is objected to because of the following informalities: claim 14 has been amended as a dependent claim; however, the claim number has been deleted with no new number being inserted. Appropriate correction is required. For examination purposes below, it is assumed that claim 14 now depends from claim 5.
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 1, 3-6, 8-9, 14-15, 21, 24-30 and 32-35 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. Specifically, the specification does not describe a fluid delivery device comprising a delivery portion and a drive portion.
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 1, 3-6, 8-9, 14-15, 21, 24-30 and 32-35 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.
In this case claims 1, 3-6, 8-9, 14-15, 21, 24-30 and 32 present one coverage in RE49848 and another in the present reissue application. This is inconsistent. In the instant reissue application, claims 1-32 should be indicated as cancelled since they have issued in RE49848 and any amended original claim or new claim should be numbered starting with claim 33.
Claim 5 recites the limitation "the control unit comprises a rotor or an axial pump element.” The control unit and the pump have already been presented in claim 1 it is unclear if the control unit now includes a rotor or an axial pump separate from the pump already claimed in claim 1 from which claim 5 depends. Appropriate correction is required.
Claim 6 recites the limitation "the rotor comprises a primary rotor to transfer rotational force to a pump rotor.” The control unit and the pump have already been presented in claim 1 it is unclear if “a pump rotor” is separate from the pump already claimed in claim 1 from which ultimately claim 6 depends. Appropriate correction is required.
Claim 14 recites the limitation "wherein the axial pump element is connected to the rotor.” However, claim 14 is assumed to depend from claim 5 in which the rotor and axial pump element are presented in the alternative. Appropriate correction is required.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 3-4, 27-30 and 32-35 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2002/0169439 A1 to Flaherty (“Flaherty”).
Regarding claim 1, Flaherty discloses a fluid delivery device (see Fig. 3) comprising: a delivery portion (800) configured to be placed in dermal contact with a patient (para. [0046] “[a]s shown, the device 10 also includes an adhesive layer 201 on the outer surface of the disposable housing 802 for securing the device 10 directly to the skin of a patient. The adhesive layer 201 is preferably provided in a continuous ring encircling the exit port assembly 70 in order to provide a protective seal around skin penetrated by the cannula 72.”) and comprising: (i) at least one reservoir (30) configured to be fluidically connected (via fluid transport tube 77) to an injection needle (72), the at least one reservoir configured to be loaded into the delivery portion when in use (see Fig. 3 and para. [0115]); (ii) a pump (48) having a component (see para. [0049], “the metering portion 48 may include a rotary peristaltic head, linear peristaltic mechanism, electromagnetic fluid propulsion, a displacement pump, or other means for moving fluid from the reservoir 30 to the exit port assembly 70. Such propulsion means may be accomplished by a rotary peristaltic head included in the metering portion 48 that is driven by a motor drive which is integrated into the meter control portion 46.”) configured to exert a force (negative pressure) on a medicament contained in said at least one reservoir (30); (iii) a control unit (821) configured to control operation of the pump (48 and see para. [0072], “[t]he power from the battery 821 can be used to supply the electronic microcontroller 50, the communication element 60, the meter control portion 46 and other electronic components of the reusable assembly 700 as well as supply power to various electrical components of disposable assembly 800.” It is noted that the battery 821 through its connection to meter control portion 46 controls the operation of the pump).
Flaherty also discloses a protrusion (871) configured to prevent formation of a fluidic connection (see Fig. 9) between the at least one reservoir and the injection needle when said delivery portion is separated from a drive portion (700); wherein the control unit is configured to be activated responsive to a relative location of the drive portion (battery contacts 720/820 engage when the drive portion 700 is in a location as shown in Fig. 8); wherein said drive portion is shaped to receive said delivery portion (see Fig. 4) wherein said drive portion includes a battery (80) and information processing electronics (46,50,60); and wherein the fluid delivery device is configured to exchange data with an external computing device (see para. [0041] “[t]he communication element 60 of the device 10 preferably receives electronic communication from the remote control device 100 using radio frequency or other wireless communication standards and protocols. In a preferred embodiment, the communication element 60 is a two-way communication element, including a receiver and a transmitter, for allowing the fluid delivery device 10 to send information back to the remote control device 100. In such an embodiment, the remote control device 100 also includes an integral communication element 60 comprising a receiver and a transmitter, for allowing the remote control device 100 to receive the information sent by the fluid delivery device 10”).
At the time of the invention, it would have been obvious to one skilled in the art to incorporate different features from different embodiments disclosed by Flaherty into a single device. Flaherty is replete with indications that different features of the invention can be modified; used with other embodiments or added to the invention. See paras. [0044], [0053], [0061], [0064], [0074], [0111], [0116], [0125] and [0127]. Furthermore, one skilled in the art would have a reasonable expectation of success in making the modifications/substitutions since the device would function as intended since each embodiment includes variations of the same components.
Regarding claim 3, Flaherty discloses the device of claim 1 and further teaches a magnetic key (para. [0049]; i.e. magnetic actuators activated by electromagnetic field)
Regarding claim 4, Flaherty discloses the device of claim 1 and further teaches wherein the pump is configured to pump the medicament from the at least one reservoir to the injection needle. See para. [0049].
Regarding claim 27, Flaherty discloses the device of claim 1 and further teaches wherein the drive portion defines a complementary profile into which at least a part of the delivery portion comprising the control unit substantially fits. See Fig. 4, elements 705 and 806.
Regarding claim 28, Flaherty discloses the device of claim 1 and further teaches comprising a sensor capable of detecting an amount of energy being transferred or transformed into pumping force by the control unit. See para. [0044] “[a]lthough not shown, the device can include sensors or transducers such as a reservoir volume transducer or a reservoir pressure transducer, for transmitting information to the local processor 50 to indicate how and when to activate the dispenser 40, or to indicate other parameters determining flow, pump flow path prime condition, blockage in flow path, contact sensors, rotary motion or other motion indicators.” (emphasis added)
Regarding 29, this claim is presented in the alternative. Flaherty discloses the device of claim 1 and further teaches … or that an atypical situation has been encountered, the at least one element being selected from the group consisting of: a warning light, audio, a vibration signal, an alarm, and any combination thereof. See para [0123], “[a]n alarm transducer can be included in the fluid delivery device 10 as well, potentially in disposable assembly 800 but preferably in reusable assembly 700. If cost, size or power constraints limit the ability to include an alarm transducer in fluid delivery device 10.”
Regarding claim 30, Flaherty discloses the device of claim 1 and further teaches wherein the fluid delivery device comprises a barcode (see para. [0113] in order to provide information. At the time of the invention, it would have been obvious to substitute an RFID chip for the bar code since both structures provide information to a reader. Furthermore, one skilled in the art would have a reasonable expectation of success in making the modifications/substitutions since the device would function as intended since each structure would provide information to a reader.
Regarding claim 32, Flaherty discloses the device of claim 1 and further teaches wherein the delivery portion comprises a capacitor or accumulator for receiving or accumulating energy from the drive portion when the drive portion is placed in proximity of the delivery portion. Flaherty teaches that the device can include capacitors. See para [0042]. Flaherty also teaches that a printed circuit board is attached to power supply/ battery 821 in Fig. 3. It would have been obvious to one skilled in the art to include a capacitor on the printed circuit board since these are well known electrical components.
Regarding claim 33, Flaherty discloses the device of claim 1 and further teaches a microfluidic channel (77) connecting the at least one reservoir to the injection needle.
Regarding claim 34, Flaherty discloses the device of claim 1 and further teaches wherein the drive portion is a hand-held drive device. See figures.
Regarding claim 35, Flaherty discloses the device of claim 1 and further teaches wherein the protrusion comprises at least one of a rod, a finger, one or more teeth, a spring, a ferromagnetic element, a coil, a pivotable arm, or a clamp. See Figs. 9, 10A and 10B.
Claims 24-26 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2002/0169439 A1 to Flaherty (“Flaherty”) in view of US 2011/0196337 A1 to Brandt et al. (“Brandt”).
Flaherty meets the claim limitations with respect to claim 1 above. Additionally, Flaherty discloses a peristaltic pump 464 that uses a keyed mating mechanism for rotating the roller assembly when the drive portion (700) is connected to the delivery portion (800). See Figs. 6-8. However, Flaherty fails to include the particular elements of claims 24-26.
Regarding claim 24, Brandt teaches wherein the delivery portion comprises at least one magnet (14).
Regarding claim 25, Brandt discloses wherein the drive portion (18b) provides rotational force or axial force to a portion (12) of the control unit when the drive portion is placed in proximity to the delivery portion.
Regarding 26, Flaherty discloses the device of claim 1 and further teaches wherein the drive portion comprises electromagnets (16b) or a drive rotor or a drive element connected to a motor, the drive rotor or the drive element comprising at least one magnet. See para. [0046] “[i]n the embodiments illustrated, the pump 12 of the disposable delivery unit 2 comprises a rotor 14 having a motor portion in the general form of a cylindrical disc in which are mounted one or more permanent magnets providing a plurality of magnetic poles therearound … In the embodiment illustrated in FIG. 3, the permanent magnets on the pump rotor are driven in rotation by magnets 16b arranged on a rotor 27 driven in rotation by a motor 19 via a gear reduction mechanism 21, in the drive module 18b of the re-usable base unit 4.”
At the time of the invention, it would have been obvious by one skilled in the art to substitute the pumping and driving components of Flaherty with the pumping and driving components of Brandt since this would have been a simple substitution of one known element for another to obtain predictable results. Furthermore, one skilled in the art would have a reasonable expectation of success in making the substitution since the device would function as intended since each device teaches a two part drug delivery construction.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE SERKE WILLIAMS whose telephone number is (571)272-4970. The examiner can normally be reached Monday through Friday core hours 8am-4pm ET.
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/CATHERINE S WILLIAMS/Reexamination Specialist, Art Unit 3993
Conferees:
/SARAH B MCPARTLIN/Reexamination Specialist, Art Unit 3993
/EILEEN D LILLIS/SPRS, Art Unit 3993
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