Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Claims 3, 11 and 17 are amended to include new limitations that are now addressed below, however, the amendment while changing the language of the claims relies on the same references previously presented. Applicant's arguments filed 01 December 2025 have been fully considered but they are not persuasive. Claims 3, 5-11, 13-18, and 20 are examined on the merits.
While Examiner recognizes that the devices have different intended uses and materials, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Examiner is not modifying the Becker device with the entire device of Goode, but noting that Goode teaches the use of different materials for the benefit of “improving ease of insertion and removal, preventing extrusion” ([0010-0011, [0013]). Goode discloses a medical tube relatively pertinent to problem posed by Applicant of implantation into anatomical structure to move material. Goode provides a conduit of a certain material to maintain an opening and achieve specific desirable characteristics. Furthermore, the selection of a known material based on its suitability for its intended use supported a prima facie obviousness (MPEP 2144.07). It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Becker to have a flexible material as in Goode to maintain an opening and achieve specific desirable characteristics which includes improving ease of insertion and removal and preventing extrusion. Further, it is also noted that the device does not claim the method nor the specific structure that is flexible i.e., the protrusions are claimed not requiring the flexible and only the body is being claimed as silicone.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 3, 5-11, 13-18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 9308358. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are more specific and constitutes a species of the instant invention. A nonstatutory double patenting rejection is appropriate where a claim in an application under examination claims subject matter that is different, but not patentably distinct, from the subject matter claimed in a prior patent or a copending application. The claim under examination is not patentably distinct from the reference claim(s) if the claim under examination is anticipated by 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, 1052, 29 USPQ2d 2010, 2015-16 (Fed. Cir. 1993). In this case:
Patented claim 19 recites all the limitations of pending claim 3.
Patented claim 19 recites all the limitations of pending claim 5.
Patented claim 19 recites all the limitations of pending claim 6.
Patented claim 19 recites all the limitations of pending claim 7.
Patented claim 2 recites all the limitations of pending claim 8.
Patented claim 10 recites all the limitations of pending claim 9.
Patented claim 12 recites all the limitations of pending claim 10.
Patented claim 19 recites all the limitations of pending claim 11.
Patented claim 19 recites all the limitations of pending claim 13.
Patented claim 19 recites all the limitations of pending claim 14.
Patented claim 10 recites all the limitations of pending claim 15.
Patented claim 12 recites all the limitations of pending claim 16.
Patented claim 19 recites all the limitations of pending claim 17.
Patented claim 18 recites all the limitations of pending claim 18.
Patented claim 10 recites all the limitations of pending claim 20.
The patented claims (species) anticipates instant invention (genus) (In re Goodman) since the entire reference claims falls within the scope of the examined claims.
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.
Claims 3, 5-11, 13-18 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Becker (US 2008/0306428) in view of Goode (US 2004/0077989).
Regarding claim 3, Becker discloses an implant device (cannula 2, figure 1) for implantation through a surgically formed fistula between a location in the lacrimal apparatus in the orbit and a paranasal sinus to fluidly connect the lacrimal apparatus ([0078], figures 13-14) in the orbit to the paranasal sinus to provide access to the paranasal sinus, the implant device comprising:
a proximal end (10) opposite a distal end (9, figure 2);
a conduit (5) extending from adjacent the proximal end to adjacent the distal end, the conduit comprising at least one anchoring surface feature (20, [0056] feature has protrusions and recesses) being spaced apart from the proximal end of the implant device by at least 4mm ([0061], “In most instances, the axial length of the threaded section ranges between about 1 mm and about 30 mm, and most typically is about 5.5 mm”, with the entire section of the helical threaded portion 20 having axial length of close to 30mm at the other limit, it already meets the limitation that one of the anchoring surface features be at least 4mm away from the proximal end since the entire section can extend 30mm along the device and thus one of the protrusions 22 would naturally would be extending that distance away from the proximal end,
an internal passage (8, figure 2) extending between the proximal end and the distal end and through the conduit, the internal passage having a first end open at the proximal end and a second end open at the distal end (figure 3, [0056]);
wherein the implant device is configured to be implanted to fluidly connect the lacrimal apparatus to the paranasal sinus through the fistula to provide access through the internal passage to the paranasal sinus ([0078], further this limitation is a recitation of intended use in which the device of Becker can be configured to fluidically connect the paranasal sinus through the fistula as there is no structural differences in the features of Becker that would prevent it from doing so):
such that the proximal end is configured to be disposed with the first end of the internal passage opening in the lacrimal apparatus (10 is with the first end of the internal passage opening, figure 2-3 and figure 13-15), the distal end is configured to be disposed in the paranasal sinus with the second end of the internal passage opening in the paranasal sinus (figure 15 shows the passage opposite the orbit and near the nose, this limitation is a recitation of intended use in which the device of Becker can be configured to fluidically connect the paranasal sinus through the fistula as there is no structural differences in the features of Becker that would prevent it from doing so) and the conduit is configured to be disposed through the fistula with at least a portion of the implant device anchored to the tissue exposed within the fistula ([0080], threaded portion contacts part 97).
Becker does not disclose a silicone body constructed of a silicone polymeric material having a durometer (Shore A) in a range of from 50 to 100;
Goode discloses a medical tube relatively pertinent to problem posed by Applicant of implantation into anatomical structure to move material. Goode teaches a silicone body (12) constructed of a silicone material having a durometer (Shore A) in a range of from 50 to 100 ([0011], [0027], silicone of the materials used).
Goode provides a conduit of a certain material to maintain an opening and achieve specific desirable characteristics ([0010-0011, [0013]). It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Becker to have a flexible material as in Goode to maintain an opening and achieve specific desirable characteristics.
Regarding claim 5, Becker discloses wherein a length of the device longitudinally along the device between the proximal end and the distal end is in a range of from 2 millimeters to 50 millimeters ([0057]).
Regarding claim 6, Becker discloses wherein a width of the internal passage is transverse to the length in a range of from 0.25 millimeter to 5 millimeters ([0058]).
Regarding claim 7, Becker discloses at least one anchoring surface feature includes protrusions and recesses (20, [0056] feature has protrusions and recesses).
Regarding claim 8, Becker further discloses wherein the protrusion areas have a height relative to the recess areas of at least or equal to 0.75 millimeter (para. 0061 describes the inside diameter of the threaded section 20 being between about 0.005 inch and about 0.89 inch, while the outside diameter of the threaded section is between about 0.01 inch and about 0.5 inch; therefore the relative height can be at least 0.75 mm).
Regarding claim 9, Becker further discloses wherein the protrusions comprise at least three spaced circumferential ridges (figure 2, the each individual ring that circles around the circumference is a ridge) with each ridge extending around the circumference of the conduit and spaced away from each of the other ridges (the each individual ring that circles around the circumference is a ridge and are spaced from other ridges via the troughs).
Regarding claim 10, Becker further discloses a head (13) at the proximal end, the internal passage extending through the head (figure 3).
Regarding claim 11, Becker discloses an implant device (cannula 2, figure 1) for implantation through a surgically formed fistula between a location in the lacrimal apparatus in the orbit and a paranasal sinus to fluidly connect the lacrimal apparatus ([0078], figures 13-14) in the orbit to the paranasal sinus to provide access to the paranasal sinus, the implant device comprising:
a proximal end (10) opposite a distal end (9, figure 2);
a conduit (5) extending from adjacent the proximal end to adjacent the distal end, the conduit comprising at least one anchoring surface feature (20, [0056] feature has protrusions and recesses), being spaced apart from the proximal end of the implant device by at least 4mm ([0061], “In most instances, the axial length of the threaded section ranges between about 1 mm and about 30 mm, and most typically is about 5.5 mm”, with the entire section of the helical threaded portion 20 having axial length of close to 30mm at the other limit, it already meets the limitation that one of the anchoring surface features be at least 4mm away from the proximal end since the entire section can extend 30mm along the device and thus one of the protrusions 22 would naturally would be extending that distance away from the proximal end,
an internal passage (8, figure 2) extending between the proximal end and the distal end and through the conduit, the internal passage having a first end open at the proximal end and a second end open at the distal end (figure 3, [0056]);
wherein the implant device is configured to be implanted to fluidly connect the lacrimal apparatus to the paranasal sinus through the fistula to provide access through the internal passage to the paranasal sinus ([0078], further this limitation is a recitation of intended use in which the device of Becker can be configured to fluidically connect the paranasal sinus through the fistula as there is no structural differences in the features of Becker that would prevent it from doing so):
such that the proximal end is configured to be disposed with the first end of the internal passage opening in the lacrimal apparatus (10 is with the first end of the internal passage opening, figure 2-3 and figure 13-15), the distal end is configured to be disposed in the paranasal sinus with the second end of the internal passage opening in the paranasal sinus (figure 15 shows the passage opposite the orbit and near the nose, this limitation is a recitation of intended use in which the device of Becker can be configured to fluidically connect the paranasal sinus through the fistula as there is no structural differences in the features of Becker that would prevent it from doing so) and the conduit is configured to be disposed through the fistula with at least a portion of the implant device anchored to the tissue exposed within the fistula ([0080], threaded portion contacts part 97).
Becker does not disclose a silicone body constructed of a silicone polymeric material having a durometer (Shore A) in a range of from 50 to 100;
Goode discloses a medical tube relatively pertinent to problem posed by Applicant of implantation into anatomical structure to move material. Goode teaches a silicone body (12) constructed of a silicone material having a durometer (Shore A) in a range of from 50 to 100 ([0011], [0027], silicone of the materials used).
Goode provides a conduit of a certain material to maintain an opening and achieve specific desirable characteristics ([0010-0011, [0013]). It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Becker to have a flexible material as in Goode to maintain an opening and achieve specific desirable characteristics.
Regarding claim 13, Becker discloses at least one anchoring surface feature includes protrusions and recesses (20, [0056] feature has protrusions and recesses).
Regarding claim 14, Becker further discloses wherein the protrusion areas have a height relative to the recess areas of at least or equal to 0.75 millimeter (para. 0061 describes the inside diameter of the threaded section 20 being between about 0.005 inch and about 0.89 inch, while the outside diameter of the threaded section is between about 0.01 inch and about 0.5 inch; therefore the relative height can be at least 0.75 mm).
Regarding claim 15, Becker further discloses wherein the protrusions comprise at least three spaced circumferential ridges (figure 2, the each individual ring that circles around the circumference is a ridge) with each ridge extending around the circumference of the conduit and spaced away from each of the other ridges (the each individual ring that circles around the circumference is a ridge and are spaced from other ridges via the troughs).
Regarding claim 16, Becker further discloses a head (13) at the proximal end, the internal passage extending through the head (figure 3).
Regarding claim 17, Becker discloses an implant device (cannula 2, figure 1) for implantation through a surgically formed fistula between a location in the lacrimal apparatus in the orbit and a paranasal sinus to fluidly connect the lacrimal apparatus ([0078], figures 13-14) in the orbit to the paranasal sinus to provide access to the paranasal sinus, the implant device comprising:
a proximal end (10) opposite a distal end (9, figure 2);
a conduit (5) extending from adjacent the proximal end to adjacent the distal end, the conduit comprising at least one anchoring protrusion (20, [0056]), being spaced apart from the proximal end of the implant device by at least 4mm ([0061], “In most instances, the axial length of the threaded section ranges between about 1 mm and about 30 mm, and most typically is about 5.5 mm”, with the entire section of the helical threaded portion 20 having axial length of close to 30mm at the other limit, it already meets the limitation that one of the anchoring surface features be at least 4mm away from the proximal end since the entire section can extend 30mm along the device and thus one of the protrusions 22 would naturally would be extending that distance away from the proximal end, the conduit constructed of a polymeric material ([0056], PMMA)
an internal passage (8, figure 2) extending between the proximal end and the distal end and through the conduit, the internal passage having a first end open at the proximal end and a second end open at the distal end (figure 3, [0056]);
wherein the implant device is configured to be implanted to fluidly connect the lacrimal apparatus to the paranasal sinus through the fistula to provide access through the internal passage to the paranasal sinus ([0078], further this limitation is a recitation of intended use in which the device of Becker can be configured to fluidically connect the paranasal sinus through the fistula as there is no structural differences in the features of Becker that would prevent it from doing so):
such that the proximal end is configured to be disposed with the first end of the internal passage opening in the lacrimal apparatus (10 is with the first end of the internal passage opening, figure 2-3 and figure 13-15), the distal end is configured to be disposed in the paranasal sinus with the second end of the internal passage opening in the paranasal sinus (figure 15 shows the passage opposite the orbit and near the nose, this limitation is a recitation of intended use in which the device of Becker can be configured to fluidically connect the paranasal sinus through the fistula as there is no structural differences in the features of Becker that would prevent it from doing so) and the conduit is configured to be disposed through the fistula with at least a portion of the implant device anchored to the tissue exposed within the fistula ([0080], threaded portion contacts part 97).
Goode does not teach a silicone body constructed of a silicone polymeric material having a durometer in a range of 50 to 100 and a silicone anchor protrusion.
Goode teaches a silicone body (12) constructed of silicone and shore hardness of 50-100 ([0011], [0027]) and a silicone anchor protrusion (14, [0011], [0027]).
Goode provides a conduit of a certain material to maintain an opening and achieve specific desirable characteristics ([0010-11]). It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Becker to have a flexible material as in Goode to maintain an opening and achieve specific desirable characteristics.
Regarding claims 18, Becker does not disclose the polymeric material of the conduit having a durometer in a range of 50 to 100.
Goode discloses a medical tube relatively pertinent to problem posed by Applicant of implantation into anatomical structure to move material. Goode teaches a conduit (12) constructed of silicone and shore hardness of 50-100 ([0011], [0027]).
Goode provides a conduit of a certain material to maintain an opening and achieve specific desirable characteristics ([0010-11]). It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Becker to have a flexible material as in Goode to maintain an opening and achieve specific desirable characteristics.
Regarding claim 20, Becker further discloses wherein the anchor protrusions comprise a circumferential ridges (figure 2, the each individual ring that circles around the circumference is a ridge) extending around the circumference of the conduit and spaced away from any other ridges (the each individual ring that circles around the circumference is a ridge and are spaced from other ridges via the troughs).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAI H WENG/Primary Examiner, Art Unit 3781