DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed July 06, 2026 has been entered. Claims 2, 6-8, and 10-21 remain pending in the application. Claims 1, 3-5, and 9 have been cancelled. Applicant’s amendments to the claims have overcome the objections previously set forth in the Non-Final Office Action mailed April 07, 2026.
Terminal Disclaimer
The terminal disclaimer filed on July 03, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of USPN 10596330 and USPN 11654250 has been reviewed and is accepted. The terminal disclaimer has been recorded. The accepted terminal disclaimer has overcome the nonstatutory double patenting rejections of claims 2-21 presented in the Non-Final Rejection mailed 04/07/26.
Claim Objections
Claim 6 is objected to because there is a lack of antecedent basis for “the device” in line 1 as opposed to “the surgical device”. Appropriate correction is required.
Claim 11 is objected to because there is a lack of antecedent basis for “the device” in line 1 as opposed to “the surgical device”. Appropriate correction is required.
Claim 12 is objected to because there is a grammatical error regarding “the one or more implants includes…” in lines 1-2 as opposed to “the one or more implants include…”. Appropriate correction is required.
Claim 13 is objected to because there is a grammatical error regarding “the one or more implants is…” in lines 1-2 as opposed to “the one or more implants are…”. Appropriate correction is required.
Claim 14 is objected to because there is a grammatical error regarding “the one or more implants is…” in lines 1-2 as opposed to “the one or more implants are…”. 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, 7-12, 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) and further in view of Krueger et al. (US 20050154412).
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]);
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]), the slider mechanism including:
a body (proximal end of piston 14) configured to be slidably received within the elongated bore (Figures 5-10); and
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).
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, the slider mechanism including: a pair of opposing flexible arms disposed proximate the flexible pin and configured to project at an angle both laterally and proximally therefrom, the pair of flexible arms including a corresponding pair of latches at a distal end thereof, the pair of flexible arms configured to axially register with corresponding pairs of one or more openings defined in opposing sides of the elongated bore to regulate delivery of the one or more implants dependent upon distal advancement of the slider mechanism within the elongated bore, and wherein the pair of latches is configured to prevent proximal movement of the slider mechanism once the pair of flexible arms is disposed within any one of the corresponding pairs of one or more openings.
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]).
Modified Cheikh fails to explicitly disclose the slider mechanism including: a pair of opposing flexible arms disposed proximate the flexible pin and configured to project at an angle both laterally and proximally therefrom, the pair of flexible arms including a corresponding pair of latches at a distal end thereof, the pair of flexible arms configured to axially register with corresponding pairs of one or more openings defined in opposing sides of the elongated bore to regulate delivery of the one or more implants dependent upon distal advancement of the slider mechanism within the elongated bore, and wherein the pair of latches is configured to prevent proximal movement of the slider mechanism once the pair of flexible arms is disposed within any one of the corresponding pairs of one or more openings.
Krueger teaches a surgical device (delivery system 100) comprising a barrel (barrel 210) including an elongated bore (internal cavity 230), the barrel operably connected to a needle alignment portion (needle retention portion 220); a hollow needle (needle 202); one or more solid implants (implant 20) disposed within the hollow needle (Figure 33a); and a selectively removable actuator (slider mechanism 300 and obturator 400) disposed within the elongated bore and configured to incrementally deliver each of the one or more of the implants from the hollow needle (“movement of the slider mechanism 300 within the barrel 210 results in urging the obturator 400 to urge the implant 20 out of the needle 202.” [0096]), wherein the selectively removable actuator includes a slider mechanism (slider mechanism 300) configured to regulate the delivery of the one or more implants, the slider mechanism including: a body (body 302) configured to be slidably received within the elongated bore (“The slider mechanism 300 (separately shown in FIGS. 38-44) has a generally cylindrical body 302 sized to be slidably received within the barrel cavity 230.” [0102]); a flexible pin (pin 306) extending distally from the body and configured to extend through the needle alignment portion and into the hollow needle (“A pin 306 extends axially away from a distal end of the body 302 and is sized to pass through the distal hole 232 and into the opening 224. Further, the pin 306 is sized to be passed into the proximal end 205 of the needle 202 and oppose the obturator 400 within the needle 202 when the slider mechanism 300 is mounted within the barrel cavity 230.” [0103]); and a pair of opposing flexible arms (lever arms 310; “The lever arms 310 are resilient” [0105]) disposed proximate the flexible pin (Figure 38) and configured to project at an angle both laterally and proximally therefrom (Figure 39), the pair of flexible arms including a corresponding pair of latches (stops 314) at a distal end (end 312) thereof (Figure 44), the pair of flexible arms configured to axially register with corresponding pairs of one or more openings (three openings 221, 222, 223) defined in opposing sides of the elongated bore (“The barrel 210 includes three openings 221, 222, and 223 on opposite sides of the barrel 210 and spaced along its axial dimension.” [0093]) to regulate delivery of the one or more implants dependent upon distal advancement of the slider mechanism within the elongated bore (“the openings 221-223 will cooperate with the slider mechanism 300 to provide a visual, audible and tactile indication to a physician of the degree of ejection of the implant 20 from the needle 202.” [0093]; detailed in [0107-0112]), and wherein the pair of latches is configured to prevent proximal movement of the slider mechanism once the pair of flexible arms is disposed within any one of the corresponding pairs of one or more openings (“The resilient bias of the lever arms 310 causes the lever arms 310 to spread outwardly at the openings 223 for the ends 312 to be captured within the openings 223. On forward movement (i.e., movement of slider 300 toward the distal end 212), the angled arms 310 act as cam followers against the plastic surrounding the openings 221-223 which urges the ends 312 inwardly to clear the openings. In reverse movement, there is no corresponding cam follower and the ends 312 and stops 314 block such motion.” [0107]).
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 slider mechanism of the surgical device of Cheikh to include a pair of opposing flexible arms including a corresponding pair of latches, the pair of flexible arms configured to axially register with corresponding pairs of one or more openings defined in opposing sides of the elongated bore to regulate delivery of the one or more implants dependent upon distal advancement of the slider mechanism within the elongated bore, and wherein the pair of latches is configured to prevent proximal movement of the slider mechanism once the pair of flexible arms is disposed within any one of the corresponding pairs of one or more openings based on the teachings of Krueger to provide the user with visual, audible and tactical indications regarding the positioning of the one or more implants during delivery and prevent accidental reuse of the surgical device after the one or more implants have been delivered (Krueger [0113-0114]).
Regarding claim 7, modified Cheikh discloses the surgical device according to claim 2,
Modified Cheikh fails to explicitly disclose wherein the pairs of one or more openings in the elongated bore provide visible, audible or tactile feedback of each of the one or more implants as each of the one or more implants progresses through the hollow needle.
Krueger teaches a surgical device (delivery system 100) comprising a barrel (barrel 210); a hollow needle (needle 202); one or more solid implants (implant 20) disposed within the hollow needle; and a selectively removable actuator (slider mechanism 300 and obturator 400) including a slider mechanism (slider mechanism 300) including: a body (body 302); a flexible pin (pin 306); and a pair of opposing flexible arms (lever arms 310) including a corresponding pair of latches (stops 314), the pair of flexible arms configured to axially register with corresponding pairs of one or more openings (three openings 221, 222, 223), wherein the pairs of one or more openings in the elongated bore provide visible, audible or tactile feedback of each of the one or more implants as each of the one or more implants progresses through the hollow needle (“, the openings 221-223 will cooperate with the slider mechanism 300 to provide a visual, audible and tactile indication to a physician of the degree of ejection of the implant 20 from the needle 202.” [0093], detailed in [0107-0112]).
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 slider mechanism of the surgical device of Cheikh to include the pairs of one or more openings in the elongated bore provide visible, audible or tactile feedback of each of the one or more implants as each of the one or more implants progresses through the hollow needle based on the teachings of Krueger to provide the user with visual, audible and tactical indications regarding the positioning of the one or more implants during delivery to allow the user to maintain a visual focus on the implant site itself (Krueger [0114]).
Regarding claim 8, modified Cheikh discloses the surgical device according to claim 2.
Modified Cheikh fails to explicitly disclose wherein the pair of latches, when engaged, prevents unintended removal of the selectively removable actuator from the surgical device while allowing distal advancement of the selectively removable actuator.
Krueger teaches a surgical device (delivery system 100) comprising a barrel (barrel 210); a hollow needle (needle 202); one or more solid implants (implant 20); and a selectively removable actuator (slider mechanism 300 and obturator 400) including a slider mechanism (slider mechanism 300) including: a body (body 302); a flexible pin (pin 306); and a pair of opposing flexible arms (lever arms 310) including a corresponding pair of latches (stops 314) at a distal end (end 312) thereof (Figure 44), the pair of flexible arms configured to axially register with corresponding pairs of one or more openings (three openings 221, 222, 223; “the openings 221-223 will cooperate with the slider mechanism 300 to provide a visual, audible and tactile indication to a physician of the degree of ejection of the implant 20 from the needle 202.” [0093]; detailed in [0107-0112]), wherein the pair of latches, when engaged, prevents unintended removal of the selectively removable actuator from the surgical device while allowing distal advancement of the selectively removable actuator (“On forward movement (i.e., movement of slider 300 toward the distal end 212), the angled arms 310 act as cam followers against the plastic surrounding the openings 221-223 which urges the ends 312 inwardly to clear the openings. In reverse movement, there is no corresponding cam follower and the ends 312 and stops 314 block such motion.” [0107], detailed [0107-0112]).
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 slider mechanism of the surgical device of Cheikh to include the pair of latches, when engaged, prevents unintended removal of the selectively removable actuator from the surgical device while allowing distal advancement of the selectively removable actuator based on the teachings of Krueger to provide the user with visual, audible and tactical indications regarding the positioning of the one or more implants during delivery and prevent accidental reuse of the surgical device after the one or more implants have been delivered (Krueger [0113-0114]).
Regarding claim 10, modified Cheikh discloses the surgical 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 surgical 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 surgical device according to claim 2, wherein the one or more implants 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 surgical device according to claim 12, wherein the drug includes an angiotensin converting 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 surgical 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 surgical 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 surgical 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 6 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) further in view of Krueger et al. (US 20050154412) as applied in claims 2 and 12 above, and further in view of Eaton et al. (USPN 7951135).
Regarding claim 6, modified Cheikh discloses the surgical device according to claim 2.
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 13, modified Cheikh discloses the surgical device according to claim 2, wherein the one or more implants 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 one or more implants 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 implants 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 surgical device according to claim 12, wherein the one or more implants 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 one or more implants 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 implants 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) further in view of Krueger et al. (US 20050154412) 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 surgical 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]).
Response to Arguments
Applicant’s arguments with respect to claims 2, 6-8, and 10-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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