DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 3-21 are objected to because there is a lack of antecedent basis for “The device…” in the preamble, line 1 of each claim as opposed to “The surgical device…”. There are two instances of “the device” as opposed to “the surgical device” in claims 6, 9, and 11, and three instances in claim 8. Appropriate correction is required.
Claim 7 is objected to because there is a lack of antecedent basis for “the progress of each of the one or more implants though the hollow needle” in lines 2-3. Appropriate correction is required.
Claim 12 is objected to because there is a lack of antecedent basis for “the implant” in line 1 as opposed to “the one or more implants”. Appropriate correction is required.
Claim 13 is objected to because there is a lack of antecedent basis for “the implant” in line 1 as opposed to “the one or more implants”. Appropriate correction is required.
Claim 14 is objected to because there is a lack of antecedent basis for “the implant” in lines 1 and 2 (two instances) as opposed to “the one or more implants”. Appropriate correction is required.
Claim 15 is objected to because there appears to be a typo regarding “angiotensin convertin enzyme (ACE) inhibitor” in line 2 as opposed to “angiotensin converting enzyme (ACE) inhibitor”. 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 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.
Claims 2-3, 8, 12, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Cheikh (US 20020111603) in view of Saidi et al. (US 20140243975).
Regarding claim 2, Cheikh discloses a surgical device (Figures 5-10), comprising:
a barrel (tubular guide 11) including an elongated bore defined therein (Figure 5), the barrel operably connected to a needle alignment portion (catheter 12) having a distal end (Figure 5);
a hollow needle (needle 13) configured to project from the distal end of the needle alignment portion and configured for submucosal insertion into mucosal turbinate tissue (Figures 5 and 7; “the bent end 13a facilitates the oblique injection of the solid form 9 into the wall or the mucous membrane 17.” [0154]);
one or more biodegradable, drug-eluting solid implants (solid form 9; “a sustained-release solid formulation for parenteral administration comprising a homogeneous mixture of an active principle in non-dispersed state and of a biologically compatible and biodegradable excipient” [Abstract]) disposed within the hollow needle, each of the one or more implants having a length (Figures 9-10; “the implant obtained to have…a length of 12.5 mm…It will likewise be able to be implanted in the mucous membrane of the turbinate bone with the aid of the device shown diagrammatically in FIGS. 5 to 10.” [0173]); and
a selectively removable actuator (piston 14 and push button 20) disposed within the elongated bore and configured to incrementally deliver each of the one or more of the implants from the hollow needle into the mucosal turbinate tissue (Figures 5-10; “The invasive system comprises a tubular piece 50 partially inserted in the tissue through the surface P' of the latter, and a tubular guide 11 which can be a fibroscope or an endoscope, in which a catheter 12 can be mounted. The latter forms a guide for the administration device formed by a needle 13 and a piston 14 for extraction of the solid form 9 in the tissue 17.” [0152]).
Cheikh fails to explicitly disclose each of the one or more implants having one or more implant withdrawal- discouraging, mucosal tissue-engaging surface features along the length;
and submucosally bury at least one of the implant withdrawal- discouraging, mucosal tissue-engaging surface features in the mucosal turbinate tissue.
Saidi teaches a surgical device (nasal implant system 3200) comprising a hollow needle (needle 3208); and a biodegradable solid implant (implant 3202: “An implant 3202 such as, e.g., one of the implants described with respect to FIGS. 10A-N above” [0184]; “the implant includes a biodegradable material.” [0010]) disposed within the hollow needle (Figure 32D), the implant having one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features along the length (Figure 10A: “FIG. 10A shows an implant comprising scallops such as a series of circular segments or angular projections. Such scallops, segments or projections may provide additional surface area (e.g. for tissue interaction) to reduce or prevent implant movement” [0152]); and an actuator (piston 3210 and pusher 3216) configured to deliver the implant form the hollow needle into mucosal tissue (Figures 32A-D; see all of [0185]) and submucosally bury at least one of the implant withdrawal-discouraging, mucosal tissue-engaging surface features in the mucosal tissue (“A method for using an implant may include the steps of moving the implant though the mucosa, passing the implant through the nasal region medial to the lateral cartilage, and passing the implant along the maxilla. An implant may additionally, or instead, be placed for treating a spreader region, submucosally, between the lateral cartilage and septal cartilage.” [0122]; “FIG. 10A shows an implant comprising scallops such as a series of circular segments or angular projections. Such scallops, segments or projections may provide additional surface area (e.g. for tissue interaction) to reduce or prevent implant movement” [0152]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the one or more biodegradable, drug-eluting solid implants of the surgical device of Cheikh to include one or more implant withdrawal- discouraging, mucosal tissue-engaging surface features along the length; and submucosally bury at least one of the implant withdrawal- discouraging, mucosal tissue-engaging surface features in the mucosal turbinate tissue based on the teachings of Saidi to provide reduce movement of the implant by increasing surface area there therefore tissue interaction (Saidi [0152]).
Regarding claim 3, modified Cheikh discloses the device according to claim 2, wherein the selectively removable actuator includes a slider mechanism (piston 14 and push button 20) configured to regulate the delivery of the one or more implants into the mucosal turbinate tissue (“Once the solid form 9 and the bent end 13a have been injected, the stop 10 of the push button 20 is removed, and the needle 13 is withdrawn by traction on the lugs 16 without moving the piston 14 in order to deposit the solid form 9 in the tissue 17 (FIG. 9). When the bevel 13b of the needle 13 reaches the end of the piston 14, the latter is withdrawn with the needle 13, leaving the solid form 9 in place, this movement being obtained by traction on the push button 20 and the lugs 16 (FIG. 10).” [0155]).
Regarding claim 8, modified Cheikh discloses the device according to claim 2, wherein the device has one or more latches (stops 10, 15) that prevent unintended removal of the selectively removable actuator from the device (“The device has two movable stops (10, 15) of which the first 10 is a sleeve arranged in a push button 20 coaxial to the piston 14, this stop 10 and the push button being longitudinally truncated (FIG. 8); the second is a tubular piece 15, likewise truncated (FIG. 6), interposed between the catheter 12 and the push button 20.” [0153]; “The stop 15 is withdrawn; the needle 13 is moved with the aid of the push button 20 containing the stop 10 (FIG. 7).” [0154]; “Once the solid form 9 and the bent end 13a have been injected, the stop 10 of the push button 20 is removed, and the needle 13 is withdrawn by traction on the lugs 16 without moving the piston 14 in order to deposit the solid form 9 in the tissue 17 (FIG. 9).” [0155]).
Regarding claim 10, modified Cheikh discloses the device according to claim 2, wherein at least one of the needle alignment portion or the hollow needle is bent (“the needle 13 can have at its end a bent shape 13a obtained by liberation of an elastic preconstraint of the needle 13 in the guide. Once the constraint of the guide is liberated, the bent end 13a facilitates the oblique injection of the solid form 9 into the wall or the mucous membrane 17.” [0154]).
Regarding claim 11, modified Cheikh discloses the device according to claim 2, wherein the device is sealed in sterile packaging (“Irradiation by sterilization, after packaging of the device, is carried out with 25 kGy.” [0326]).
Regarding claim 12, modified Cheikh discloses the device according to claim 2, wherein the implant includes a polymeric matrix with a drug impregnated therein, a drug dispersed therein, or a drug coated thereon (“It is possible, for example, to make rods of dexamethasone phosphate matrixed to a level of 15% in PLGA 50-50 according to the following steps: weighing of the raw materials, mixing of the two powders, extrusion, dosage, packaging and sterilization.” [0173]).
Regarding claim 15, modified Cheikh discloses the device according to claim 12, wherein the drug includes an angiotensin convertin enzyme (ACE) inhibitor; angiotensin receptor blocker (ARBS); antihistamine; steroidal or non-steroidal anti-inflammatory agent; chymase inhibitor; cyclooxygenase-2 (COX-2) inhibitor; decongestant; matrix metalloproteinase (MMP) inhibitor; mucolytic; therapeutic polymer or combinations thereof (“It is possible, for example, to make rods of dexamethasone phosphate matrixed to a level of 15% in PLGA 50-50 according to the following steps: weighing of the raw materials, mixing of the two powders, extrusion, dosage, packaging and sterilization.” [0173]).
Regarding claim 16, modified Cheikh discloses the device according to claim 12, wherein the drug includes doxycycline, TIMP metallopeptidase inhibitor 1, or dexamethasone (“It is possible, for example, to make rods of dexamethasone phosphate matrixed to a level of 15% in PLGA 50-50 according to the following steps: weighing of the raw materials, mixing of the two powders, extrusion, dosage, packaging and sterilization.” [0173]).
Regarding claims 17-18, modified Cheikh discloses the device according to claim 2.
Modified Cheikh fails to explicitly disclose the one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features include projections, as required by claim 17; and wherein the projections comprise bumps, ribs, hooks or a ratchet rack, as required by claim 18.
Saidi teaches a surgical device (nasal implant system 3200) comprising a hollow needle (needle 3208); and a biodegradable solid implant (implant 3202: “An implant 3202 such as, e.g., one of the implants described with respect to FIGS. 10A-N above” [0184]; “the implant includes a biodegradable material.” [0010]) disposed within the hollow needle (Figure 32D), the implant having one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features that include projections comprising bumps, ribs, hooks or a ratchet rack (Figure 10A: “FIG. 10A shows an implant comprising scallops such as a series of circular segments or angular projections. Such scallops, segments or projections may provide additional surface area (e.g. for tissue interaction) to reduce or prevent implant movement” [0152]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the one or more biodegradable, drug-eluting solid implants of the surgical device of Cheikh to include one or more implant withdrawal- discouraging, mucosal tissue-engaging surface features including projections comprising bumps or ribs based on the teachings of Saidi to provide reduce movement of the implant by increasing surface area there therefore tissue interaction (Saidi [0152]).
Regarding claims 19-20, modified Cheikh discloses the device according to claim 2.
Modified Cheikh fails to explicitly disclose the one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features include recesses, as required by claim 19; and wherein the recesses comprise dimples, grooves or porosity, as required by claim 20.
Saidi teaches a surgical device (nasal implant system 3200) comprising a hollow needle (needle 3208); and a biodegradable solid implant (implant 3202: “An implant 3202 such as, e.g., one of the implants described with respect to FIGS. 10A-N above” [0184]; “the implant includes a biodegradable material.” [0010]) disposed within the hollow needle (Figure 32D), the implant having one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features that include recesses comprising dimples, grooves or porosity (Figure 10A: “FIG. 10A shows an implant comprising scallops such as a series of circular segments or angular projections. Such scallops, segments or projections may provide additional surface area (e.g. for tissue interaction) to reduce or prevent implant movement” [0152]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the one or more biodegradable, drug-eluting solid implants of the surgical device of Cheikh to include one or more implant withdrawal- discouraging, mucosal tissue-engaging surface features including recesses comprising dimples, grooves or porosity based on the teachings of Saidi to provide reduce movement of the implant by increasing surface area there therefore tissue interaction (Saidi [0152]).
Claims 4-7, 9, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Cheikh (US 20020111603) in view of Saidi et al. (US 20140243975) as applied in claims 2 and 12 above, and further in view of Eaton et al. (USPN 7951135).
Regarding claim 4, modified Cheikh discloses the device according to claim 3.
Modified Cheikh fails to explicitly disclose the elongated bore includes one or more openings axially defined along a side thereof, the openings configured to mechanically interface with the slider mechanism to regulate delivery of the one or more implants in increments.
Eaton discloses a surgical device (Figures 2A-2B) comprising a barrel (handle 48) including an elongated bore (“A handle 48, as shown in FIG. 2B, may be coupled to conduit 28 such that the handle lumen forms a continuous lumen with the lumen 32 of the conduit 28.” [Col 8, lines 28-30]; Figure 2B); a hollow needle (conduit 28); one or more biodegradable, drug-eluting solid implants (implants 44, 46; Figure 2A; “a biodegradable implant for treating sinusitis that includes a sustained release therapeutic agent dispersed within a biodegradable matrix” [Col 2, lines 7-9]); and a selectively removable actuator including a slider mechanism (pusher 40) disposed within the elongated bore and configured to incrementally deliver each of the one or more implants from the hollow needle (“Pusher 40 is distally advanced a preset distance to slidably engage the most proximal implant 44 within lumen 32. The pusher 40 is then further distally advanced a preset distance, e.g., a distance approximately equal to the length of one implant, to move the most distal implant 46 through opening 36 into the sinus.” [Col 8, lines 22-27]); wherein the elongated bore includes one or more openings (stepped slot 44) axially defined along a side thereof (Figure 2B), the openings configured to mechanically interface with the slider mechanism to regulate delivery of the one or more implants in increments (“A handle 48, as shown in FIG. 2B, may be coupled to conduit 28 such that the handle lumen forms a continuous lumen with the lumen 32 of the conduit 28. The pusher 40 can then slide through this continuous lumen. The handle 48 further includes an injector 42, adjacent to and longitudinally aligned with the pusher 40, and a stepped slot 44 with various positions "O", "A", "B", and "C". Initially, when the injector 42 is pressed, the pusher 40 is distally advanced, and a key 46 coupled to the injector 42 moves the pusher 40 between positions "O" and "A". The distance between positions "O" and "A" is approximately equal to the length of the dispensed implant. Pusher 40 may then be rotated to move the key 46 from position "A" to position "B" in the stepped slot 44. Pressing the injector 42 again then moves the key along step "B" to position "C", and the pusher 40 a corresponding length to dispense another implant. Multiple implants may be delivered in this fashion, with the number of implants delivered depending on the number of steps in the stepped slot.” [Col 8, lines 27-45]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the elongated bore of the surgical device of Cheikh to include one or more openings axially defined along a side thereof, the openings configured to mechanically interface with the slider mechanism to regulate delivery of the one or more implants in increments based on the teachings of Eaton to allow for incremental delivery of multiple implants without requiring the surgical device to be removed from the treatment site to be reloaded (Eaton [Col 2, line 62 – Col 3, line 4]).
Regarding claim 5, modified Cheikh discloses the device according to claim 4, wherein the slider mechanism includes: a body (proximal end of piston 14) configured to be slidably received within the elongated bore (Figures 5-10); a flexible pin (piston 14; shown flexible as it follows the bent shape 13a in Figure 9) extending distally from the body and configured to extend through the needle alignment portion and into the hollow needle (Figures 5-10).
Modified Cheikh fails to explicitly disclose one or more flexible arms disposed proximate the flexible pin and configured to project laterally and proximally therefrom, the one or more flexible arms including corresponding one or more latches at a distal end of the one or more flexible arms configured to axially register with corresponding one or more openings in the elongated bore to regulate delivery of the one or more implants dependent upon distal advancement of the slider mechanism within the elongated bore.
Eaton discloses a surgical device (Figures 2A-2B) comprising a barrel (handle 48) including an elongated bore (Figure 2B); a hollow needle (conduit 28); one or more biodegradable, drug-eluting solid implants (implants 44, 46; Figure 2A); and a selectively removable actuator including a slider mechanism (pusher 40); wherein the elongated bore includes one or more openings (stepped slot 44) axially defined along a side thereof (Figure 2B), wherein the slider mechanism includes a body (proximal end of pusher 40) configured to be slidably received within the elongated bore (Figures 2A-2B); a flexible pin (pusher 40; “The conduit and pusher may be flexible” [Col 7, line 33]) extending distally from the body and configured to extend through the needle alignment portion and into the hollow needle (Figures 2A-2B); and one or more flexible arms (key 46; wherein key 46 is flexible because it is part of the flexible pusher 40) disposed proximate the flexible pin and configured to project laterally and proximally therefrom (Figure 2B), the one or more flexible arms including corresponding one or more latches (outer surface of key 46, shown in Figure 2B) at a distal end of the one or more flexible arms configured to axially register with corresponding one or more openings in the elongated bore to regulate delivery of the one or more implants dependent upon distal advancement of the slider mechanism within the elongated bore (“Initially, when the injector 42 is pressed, the pusher 40 is distally advanced, and a key 46 coupled to the injector 42 moves the pusher 40 between positions "O" and "A". The distance between positions "O" and "A" is approximately equal to the length of the dispensed implant. Pusher 40 may then be rotated to move the key 46 from position "A" to position "B" in the stepped slot 44. Pressing the injector 42 again then moves the key along step "B" to position "C", and the pusher 40 a corresponding length to dispense another implant. Multiple implants may be delivered in this fashion, with the number of implants delivered depending on the number of steps in the stepped slot.” [Col 8, lines 36-45]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the surgical device of Cheikh to include one or more flexible arms disposed proximate the flexible pin and configured to project laterally and proximally therefrom, the one or more flexible arms including corresponding one or more latches at a distal end of the one or more flexible arms configured to axially register with corresponding one or more openings in the elongated bore to regulate delivery of the one or more implants dependent upon distal advancement of the slider mechanism within the elongated bore based on the teachings of Eaton to allow for incremental delivery of multiple implants without requiring the surgical device to be removed from the treatment site to be reloaded (Eaton [Col 2, line 62 – Col 3, line 4]).
Regarding claim 6, modified Cheikh discloses the device according to claim 5.
Modified Cheikh fails to explicitly disclose the device contains two or more implants.
Eaton discloses a surgical device (Figures 2A-2B) comprising a barrel (handle 48) including an elongated bore (Figure 2B); a hollow needle (conduit 28); two or more biodegradable, drug-eluting solid implants (implants 44- 46; Figure 2A; “a biodegradable implant for treating sinusitis that includes a sustained release therapeutic agent dispersed within a biodegradable matrix” [Col 2, lines 7-9]; “Multiple implants may be delivered in this fashion, with the number of implants delivered depending on the number of steps in the stepped slot.” [Col 8, lines 43-45]); and a selectively removable actuator including a slider mechanism (pusher 40; [Col 8, lines 41-45]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the surgical device of Cheikh to contain two or more implants based on the teachings of Eaton to allow for incremental delivery of multiple implants without requiring the surgical device to be removed from the treatment site to be reloaded (Eaton [Col 2, line 62 – Col 3, line 4]).
Regarding claim 7, modified Cheikh discloses the device according to claim 5.
Modified Cheikh fails to explicitly disclose the one or more openings in the elongated bore provide visible, audible or tactile feedback of the progress of each of the one or more implants through the hollow needle.
Eaton discloses a surgical device (Figures 2A-2B) comprising a barrel (handle 48) including an elongated bore (Figure 2B); a hollow needle (conduit 28); one or more biodegradable, drug-eluting solid implants (implants 44, 46; Figure 2A); and a selectively removable actuator including a slider mechanism (pusher 40); wherein the elongated bore includes one or more openings (stepped slot 44) axially defined along a side thereof (Figure 2B), the one or more openings in the elongated bore provide visible, audible or tactile feedback of the progress of each of the one or more implants through the hollow needle (“The handle 48 further includes an injector 42, adjacent to and longitudinally aligned with the pusher 40, and a stepped slot 44 with various positions "O", "A", "B", and "C". Initially, when the injector 42 is pressed, the pusher 40 is distally advanced, and a key 46 coupled to the injector 42 moves the pusher 40 between positions "O" and "A". The distance between positions "O" and "A" is approximately equal to the length of the dispensed implant. Pusher 40 may then be rotated to move the key 46 from position "A" to position "B" in the stepped slot 44. Pressing the injector 42 again then moves the key along step "B" to position "C", and the pusher 40 a corresponding length to dispense another implant. Multiple implants may be delivered in this fashion, with the number of implants delivered depending on the number of steps in the stepped slot.” [Col 8, lines 27-45]; Figure 2B showing that the position of key 46 in slot 44 provides at least visual feedback).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the surgical device of Cheikh to include the one or more openings in the elongated bore provide visible, audible or tactile feedback of the progress of each of the one or more implants through the hollow needle based on the teachings of Eaton to allow for incremental delivery of multiple implants without requiring the surgical device to be removed from the treatment site to be reloaded (Eaton [Col 2, line 62 – Col 3, line 4]).
Regarding claim 9, modified Cheikh discloses the device according to claim 5.
Modified Cheikh fails to explicitly teach the one or more latches prevent unintended removal of the selectively removable actuator from the device.
Eaton discloses a surgical device (Figures 2A-2B) comprising a barrel (handle 48) including an elongated bore (Figure 2B); a hollow needle (conduit 28); one or more biodegradable, drug-eluting solid implants (implants 44, 46; Figure 2A); and a selectively removable actuator including a slider mechanism (pusher 40); wherein the elongated bore includes one or more openings (stepped slot 44), the slider mechanism includes a flexible pin (pusher 40) and one or more flexible arms including corresponding one or more latches (outer surface of key 46, shown in Figure 2B) that prevent unintended removal of the selectively removable actuator from the device (“Initially, when the injector 42 is pressed, the pusher 40 is distally advanced, and a key 46 coupled to the injector 42 moves the pusher 40 between positions "O" and "A". The distance between positions "O" and "A" is approximately equal to the length of the dispensed implant. Pusher 40 may then be rotated to move the key 46 from position "A" to position "B" in the stepped slot 44. Pressing the injector 42 again then moves the key along step "B" to position "C", and the pusher 40 a corresponding length to dispense another implant. Multiple implants may be delivered in this fashion, with the number of implants delivered depending on the number of steps in the stepped slot.” [Col 8, lines 36-45]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the surgical device of Cheikh to include the one or more latches prevent unintended removal of the selectively removable actuator from the device based on the teachings of Eaton to allow for incremental delivery of multiple implants without requiring the surgical device to be removed from the treatment site to be reloaded in a manner that prevents unintentional premature delivery (Eaton [Col 2, line 62 – Col 3, line 4], and [Col 8, lines 36-45]).
Regarding claim 13, modified Cheikh discloses the device according to claim 2, wherein the implant is configured to degrade in one month in mucosal turbinate tissue (“It will likewise be able to be implanted in the mucous membrane of the turbinate bone with the aid of the device shown diagrammatically in FIGS. 5 to 10. This solid formulation is a 1-month delayed-release formulation which contains 7.5 mg of dexamethasone and which releases on average 0.5 mg/day with an implant in each sinus.” [0173-0174]).
Modified Cheikh fails to explicitly disclose the implant is configured to degrade in less than one month.
Eaton discloses a surgical device (Figures 2A-2B) comprising a barrel (handle 48); a hollow needle (conduit 28); one or more biodegradable, drug-eluting solid implants (implants 44, 46; Figure 2A; “a biodegradable implant for treating sinusitis that includes a sustained release therapeutic agent dispersed within a biodegradable matrix” [Col 2, lines 7-9]); and a selectively removable actuator including a slider mechanism (pusher 40); wherein the implant is configured to degrade in less than one month (“The biodegradable implant may deliver a sustained release therapeutic agent over at least about one week, over at least about two weeks, over at least about three weeks, over at least about four weeks…In a preferred variation, the sustained release therapeutic agent is delivered into the sinus over about three weeks.” [Col 2, lines 43-49]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the one or more implant of the surgical device of Cheikh to be configured to degrade in less than one month based on the teachings of Eaton to allow for effective treatment of sinusitis (Eaton [Col 3, line 33-43]).
Regarding claim 14, modified Cheikh discloses the device according to claim 12, wherein the implant is configured such that the drug elutes from the implant for at least three days and for one month (“It will likewise be able to be implanted in the mucous membrane of the turbinate bone with the aid of the device shown diagrammatically in FIGS. 5 to 10. This solid formulation is a 1-month delayed-release formulation which contains 7.5 mg of dexamethasone and which releases on average 0.5 mg/day with an implant in each sinus.” [0173-0174]).
Modified Cheikh fails to explicitly disclose the implant is configured such that the drug elutes from the implant for at least three days and for less than one month.
Eaton discloses a surgical device (Figures 2A-2B) comprising a barrel (handle 48); a hollow needle (conduit 28); one or more biodegradable, drug-eluting solid implants (implants 44, 46; Figure 2A; “a biodegradable implant for treating sinusitis that includes a sustained release therapeutic agent dispersed within a biodegradable matrix” [Col 2, lines 7-9]); and a selectively removable actuator including a slider mechanism (pusher 40); wherein the implant is configured such that the drug elutes from the implant for at least three days and for less than one month (“The biodegradable implant may deliver a sustained release therapeutic agent over at least about one week, over at least about two weeks, over at least about three weeks, over at least about four weeks…In a preferred variation, the sustained release therapeutic agent is delivered into the sinus over about three weeks.” [Col 2, lines 43-49]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the one or more implant of the surgical device of Cheikh to be configured such that the drug elutes from the implant for at least three days and for less than one month based on the teachings of Eaton to allow for effective treatment of sinusitis (Eaton [Col 3, line 33-43]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Cheikh (US 20020111603) in view of Saidi et al. (US 20140243975) as applied in claim 2 above, and further in view of Arensdorf et al. (US 20090306624).
Regarding claim 21, modified Cheikh in view of Saidi discloses the device according to claim 2, including one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features (as taught by Saidi).
Modified Cheikh fails wherein the one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features include a braided structure.
Arensdorf discloses a surgical device comprising one or more biodegradable, drug-eluting solid implants (clip 1000; “The devices…are generally formed in such a way to locally deliver one or more active agents to the OMC. The devices may be made from a biodegradable polymer…the active agent may be included in the biodegradable polymer or in a coating on the device” [0009]), each of the one or more implants having one or more implant withdrawal- discouraging, mucosal tissue-engaging surface features (barbs 1002 and fibers forming biodegradable structure: “When the biodegradable polymers are fibers, they may be made via an extrusion process…Fiber meshes may be formed by braiding or weaving” [0104]) configured to engage mucosal turbinate tissue (“the clip (1000) has a series of barbs (1002) or other active fixation elements for actively securing the clip to the post-surgical anatomy, in this instance to the middle turbinate (1004).” [0060]), wherein the one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features include a braided structure (“When the biodegradable polymers are fibers, they may be made via an extrusion process…Fiber meshes may be formed by braiding or weaving” [0104]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the one or more implant withdrawal- discouraging, mucosal tissue-engaging surface features of the one or more biodegradable, drug-eluting solid implants of the surgical device of Cheikh in view Saidi to include a braided structure based on the teachings of Arensdorf to control the mesh density and therefore the degradation of the implant during use (Arensdorf [0104]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10596330 and 11654250 in view of Cheikh (US 20020111603) and further in view of Eaton et al. (USPN 7951135).
Claims 1-16 of each of USPN 10596330 and 11654250 disclose all of the features of claims 2-21 (see Table below) except for:
a barrel including an elongated bore defined therein, the barrel operably connected to a needle alignment portion having a distal end; the hollow needle configured to project from the distal end of the needle alignment portion; and a selectively removable actuator disposed within the elongated bore, as required by claim 2
the selectively removable actuator includes a slider mechanism configured to regulate the delivery of the one or more implants into the mucosal turbinate tissue, as required by claim 3
the elongated bore includes one or more openings axially defined along a side thereof, the openings configured to mechanically interface with the slider mechanism to regulate delivery of the one or more implants in increments, as required by claim 4
the slider mechanism includes: a body configured to be slidably received within the elongated bore; a flexible pin extending distally from the body and configured to extend through the needle alignment portion and into the hollow needle; and one or more flexible arms disposed proximate the flexible pin and configured to project laterally and proximally therefrom, the one or more flexible arms including corresponding one or more latches at a distal end of the one or more flexible arms configured to axially register with corresponding one or more openings in the elongated bore to regulate delivery of the one or more implants dependent upon distal advancement of the slider mechanism within the elongated bore, as required by claim 5
Regarding claims 2 and 3, Cheikh discloses a surgical device (Figures 5-10), comprising: a barrel (11) including an elongated bore defined therein (Figure 5), the barrel operably connected to a needle alignment portion (12) having a distal end (Figure 5); a hollow needle (13) configured to project from the distal end of the needle alignment portion and configured for submucosal insertion into mucosal turbinate tissue (Figures 5 and 7; [0154]); one or more biodegradable, drug-eluting solid implants (9; [Abstract]) disposed within the hollow needle, each of the one or more implants having a length (Figures 9-10; [0173]); and a selectively removable actuator (14 and 20) disposed within the elongated bore and configured to incrementally deliver each of the one or more of the implants from the hollow needle into the mucosal turbinate tissue (Figures 5-10; [0152]); wherein the selectively removable actuator includes a slider mechanism (14, 20) configured to regulate the delivery of the one or more implants into the mucosal turbinate tissue ([0155]). Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the surgical device of USPN 10596330 and/or the surgical device used in the method of USPN 11654250 to include a barrel including an elongated bore and operably connected to a needle alignment portion having a distal end; the hollow needle configured to project from the distal end of the needle alignment portion; and a selectively removable actuator disposed within the elongated bore and including a slider mechanism configured to regulate the delivery of the one or more implants into the mucosal turbinate tissue based on the teachings of Cheikh to allow for simple delivery of the biodegradable, drug-eluting solid implants into the target mucosal tissue (Cheikh [0151-0155]).
Regarding claims 4 and 5, Eaton discloses a surgical device (Figures 2A-2B) comprising a barrel (48) including an elongated bore (Figure 2B); a hollow needle (28); one or more biodegradable, drug-eluting solid implants (44, 46; Figure 2A; [Col 2, lines 7-9]); and a selectively removable actuator including a slider mechanism (40) disposed within the elongated bore and configured to incrementally deliver each of the one or more implants from the hollow needle ([Col 8, lines 22-27]); wherein the elongated bore includes one or more openings (44) axially defined along a side thereof (Figure 2B), the openings configured to mechanically interface with the slider mechanism to regulate delivery of the one or more implants in increments ( [Col 8, lines 27-45]), wherein the slider mechanism includes a body (proximal end of 40) configured to be slidably received within the elongated bore (Figures 2A-2B); a flexible pin (40; “The conduit and pusher may be flexible” [Col 7, line 33]) extending distally from the body and configured to extend through the needle alignment portion and into the hollow needle (Figures 2A-2B); and one or more flexible arms (46) disposed proximate the flexible pin and configured to project laterally and proximally therefrom (Figure 2B), the one or more flexible arms including corresponding one or more latches (outer surface of key 46, shown in Figure 2B) at a distal end of the one or more flexible arms configured to axially register with corresponding one or more openings in the elongated bore to regulate delivery of the one or more implants dependent upon distal advancement of the slider mechanism within the elongated bore ([Col 8, lines 36-45]). Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the surgical device of USPN 10596330 and/or the surgical device used in the method of USPN 11654250 to include the elongated bore includes one or more openings configured to mechanically interface with the slider mechanism to regulate delivery of the one or more implants in increments, wherein the slider mechanism includes: a body, a flexible pin, one or more flexible arms including corresponding one or more latches at a distal end of the one or more flexible arms configured to axially register with corresponding one or more openings in the elongated bore to regulate delivery of the one or more implants dependent upon distal advancement of the slider mechanism within the elongated bore based on the teachings of Eaton to allow for incremental delivery of multiple implants without requiring the surgical device to be removed from the treatment site to be reloaded (Eaton [Col 2, line 62 – Col 3, line 4]).
Nonstatutory Double Patenting
Present Claims
USPN 10596330
USPN 11654250
2
1 in view of Cheikh
1 in view of Cheikh
3
1 in view of Cheikh
1 in view of Cheikh
4
1 in view of Eaton
1 in view of Eaton
5
1 in view of Eaton
1 in view of Eaton
6
2
2
7
3
3
8
4
4
9
4
4
10
5
5
11
6
6
12
7
7
13
8
8
14
9
9
15
10
10
16
11
11
17
12
12
18
13
13
19
14
14
20
15
15
21
16
16
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783