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 1 and 7 are objected to because of the following informalities: Line 2 of claim 1 has been amended to replace the “body cavity” with a “round window niche of an ear”, but the remainder of claim 1 and claim 7 still refer to “the body cavity”. Accordingly, each occurrence of the phrase “the body cavity” (lines 6, 8, 12, 18 of claim 1 and lines 3,4 of claim 7) should be replaced with the phrase “the round window niche” or “the round window niche of the ear”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 14 has been amended to recite “the implant handle”, but this feature was introduced on line 4 as “a handle”, not “an implant handle”. Accordingly, claim 14 should be amended to recite “the handle” instead of “the implant handle”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 1, 2, 7, 10, 11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Arenberg (US Pat 6,685,697) in view of de Juan et al. (PG PUB 2021/0228849).
Re claim 1, Arenberg discloses a patient-specific implant (Fig 5) for insertion into a round window niche of an ear of a patient (as seen in Fig 4; Col 4, Lines 6-21 and Col 9, Lines 38-40), comprising: an implant body 10 (Fig 5); and a handle 100 (Fig 5) attached directly or indirectly to the implant body (as seen in Fig 5), wherein the handle is adapted for holding the implant during insertion into the round window niche (Col 28, Lines 51-67; Col 29, Lines 18-20), wherein the implant body comprises an outer contour which corresponds to an inner contour of the round window niche of the patient (as seen in Fig 4; Col 25, Lines 63-66), wherein at least the implant body contains a medical active substance (“therapeutic agents” – Col 14, Lines 65 – Col 15, Line 1) which is deliverable from the implant body to the patient (Col 14, Lines 1-6), wherein the implant is designed for remaining in the round window niche after insertion (“left in position” – Col 15, Lines 15-17). Arenberg does not disclose that the handle is wider than the implant body in an extent orthogonal to an insertion direction or that the implant has a marking around on the handle by which a spatial position and/or orientation of the implant during an implanting process in the round window niche is recognizable to a user.
De Juan, however, teaches an implant 1100 (Fig 6) comprising an implant body 1106 (Fig 6) and a handle 1105 (Fig 6) attached directly or indirectly to the implant body (as seen in Fig 6), wherein the implant body and the handle have a working channel 1110 extending therethrough, like in Arenberg; de Juan teaches that the handle is wider than the implant body in an extend orthogonal to an insertion direction (as seen in Fig 6, wherein the insertion direction is a horizontal direction; Para 64) and wherein the implant has a marking (“support ring” – Para 63; labeled in Fig A below as “rings/markings”) arranged on the handle by which a spatial position and/or orientation of the implant during an implantation process in a body cavity is recognizable to a user (since a user can see the rings with their naked eye, the user can recognize the spatial position of the implant during insertion) for the purpose of providing sufficient force/friction to inhibit movement of the implant while materials are inserted through working channel (Para 61). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Arenberg to include the handle with markings that render the handle wider than the implant body in an extent orthogonal to the insertion direction and allow a user to recognize the spatial position of the implant during implantation, as taught by de Juan, for the purpose of providing sufficient force/friction to inhibit movement of the implant while materials are inserted through the working channel (Para 61).
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Re claim 2, Arenberg discloses that the implant body is formed as a solid body having substantially no air pockets (Col 15, Lines 17-20).
Re claim 7, Arenberg as modified by de Juan in the rejection of claim 1 above discloses all the claimed features with de Juan teaching that the handle is shaped such that it rests in a form-fit on a constriction at an entry of the body cavity when the implant body reaches a correct implantation depth and a correct position in the body cavity (Para 62-64). The motivation cited in the rejection of claim 1 also applies to this claim.
Re claim 10, Arenberg as modified by de Juan in the rejection of claim 1 above discloses all the claimed features with de Juan teaching that the handle is formed as a position and/or orientation aid which supports a user in guiding the implant during insertion into the body cavity (Para 63,64).
Re claim 11, Arenberg disclose that the implant body and/or the handle is biodegradable (Col 15, Lines 11-15).
Re claim 15, the claimed phase “at least the implant body is manufactured by an additive manufacturing process” is being treated as a product-by-process limitation and since it has been held that a product-by-process limitation is not construed as being limited to the product formed by the specific process recited, therefore, even though Arenberg is silent as to the process used to form the implant body, it appears that Arenberg’s product would be the same or similar as that claimed.
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Arenberg (US Pat 6,685,697)/de Juan et al. (PG PUB 2021/0228849) in view of Arenberg (US Pat 6,045,528).
Re claim 3, Arenberg ‘697 as modified by de Juan in the rejection of claim 1 above discloses all the claimed features except that the implant body has a same compressibility as or a higher compressibility than the handle. Arenberg ‘528, however, teaches an implant 300 (Fig 7) comprising an implant body 202 (Fig 7) and a handle 302 (Fig 7), wherein the implant body has a same or a higher compressibility than the handle (Col 26, Lines 2-4) for the purpose of allowing the implant body to form a fluid tight seal with the round window niche (Col 9, Lines 51-60). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Arenberg ‘697/de Juan to include the implant body with a same compressibility as or a higher compressibility than the handle, as taught by Arenberg ‘528, for the purpose of allowing the implant body to form a fluid tight seal with the round window niche (Col 9, Lines 51-60).
Re claim 4, Arenberg ‘697 as modified by de Juan in the rejection of claim 1 above discloses all the claimed features except that the implant body is elastically compressible by at least 20%. Arenberg ‘528, however, teaches an implant 300 (Fig 7) comprising an implant body 202 (Fig 7) and a handle 302 (Fig 7), wherein the implant body is elastically compressible by at least 20% (Col 26, Lines 2-4) for the purpose of allowing the implant body to form a fluid tight seal with the round window niche(Col 9, Lines 51-60). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Arenberg ‘697/de Juan to include the implant body such that it is elastically compressible by at least 20%, as taught by Arenberg ‘528, for the purpose of allowing the implant body to form a fluid tight seal with the round window niche (Col 9, Lines 51-60).
Re claim 5, Arenberg ‘697 as modified by de Juan in the rejection of claim 1 above discloses all the claimed features except that the implant body has a same or a greater elasticity than the handle. Arenberg ‘528, however, teaches an implant 300 (Fig 7) comprising an implant body 202 (Fig 7) and a handle 302 (Fig 7), wherein the implant body has a same or a greater elasticity than the handle (Col 26, Lines 2-4) for the purpose of allowing the implant body to form a fluid tight seal with the round window niche (Col 9, Lines 51-60). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Arenberg ‘697/de Juan to include the implant body with a same or a higher elasticity than the handle, as taught by Arenberg ‘528, for the purpose of allowing the implant body to form a fluid tight seal with the round window niche (Col 9, Lines 51-60).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Arenberg (US Pat 6,685,697)/de Juan et al. (PG PUB 2021/0228849) in view of Aebischer (US Pat 5,182,111).
Re claim 12, Arenberg as modified by de Juan in the rejection of claim 1 above discloses all the claimed features except that the implant body has a multilayer structure wherein each layer of the structure contains a different concentration of a medical active substance and/or wherein each layer of the structure contains a different medical active substance. Aebischer, however, teaches an implant 90 (Fig 9) having a multilayer structure (as seen in Fig 9, two layers 46 and 48 are formed) wherein each layer of the structure contains a different medical active substance (as seen in Fig 9, layer 46 contains substance 25 while layer 48 contains different substance 27) (Col 9, Lines 52-60) for the purpose of providing a synergistic effect (Col 6, Lines 29-32). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Arenberg/de Juan to include the implant body with a multilayer structure wherein each layer of the structure contains a different medical active substance, as taught by Aebischer, for the purpose of providing a synergistic effect (Col 6, Lines 29-32).
Re claim 13, Arenberg as modified by de Juan in the rejection of claim 1 above discloses all the claimed features except that the implant body comprises active substance-producing cells integrated in the implant body, wherein the medical active substance that is deliverable to the patient is produced by the active substance-producing cells. Aebischer, however, teaches an implant body 70 (Fig 7) comprising active substance-producing cells 25 (Fig 7) integrated in the implant body that produce a medical active substance that can be delivered to the patient (Col 6, Lines 22-32) for the purpose of providing more reliable, sustained and controlled delivery of the medical active substance (Col 2, Lines 52-59). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Arenberg/de Juan to include the implant body with active substance-producing cells that produce the medical active substance, as taught by Aebischer, for the purpose of providing more reliable, sustained and controlled delivery of the medical active substance (Col 2, Lines 52-59).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Arenberg (US Pat 6,685,697)/de Juan et al. (PG PUB 2017/0340485) in view of Baum et al. (PG PUB 2024/0091410).
Re claim 15, Arenberg as modified by de Juan in the rejection of claim 1 above disclose all the claimed features except explicitly disclosing that at least the implant body is manufactured by an additive manufacturing process. As set forth above, this phrase is a product-by-process limitation that is read upon by Arenberg. Alternatively, Baum teaches that additive manufacturing is one of the fastest growing applications for the fabrication of three-dimensional drug delivery implants (Para 163). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Arenberg/de Juan to form the implant body by an additive manufacturing process, as taught by Baum, since additive manufacturing is one of the fastest growing applications for the fabrication of three-dimensional drug delivery implants (Para 613).
Response to Arguments
Applicant's arguments filed 7/15/2026 have been fully considered but are moot in view of the present rejections that utilize the newly-cited de Juan reference to modify the previously-cited Arenberg reference.
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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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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