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 .
Election/Restrictions
Applicant’s election of Group I in the reply filed on 5/11/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Accordingly, claim 16 has been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statement filed 3/6/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Specifically, none of the five non-patent literature documents listed have been provided by the Applicant. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claim 3 is objected to because of the following informalities: Claim 3 is grammatically incorrect. In order to be grammatically correct, it is suggested to amend line 2 to recite “a same compressibility as or a higher compressibility than”. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: Claim 5 is grammatically incorrect. In order to be grammatically correct, it is suggested to amend line 3 to recite “a same elasticity as or a greater elasticity than”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: The phrase “the insertion direction” lacks proper antecedent basis since it is the first time that this feature is being introduced. In order to overcome this objection, it is suggested to amend this phrase to recite “[[the]] an insertion direction”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: Claim 7 is grammatically incorrected. In order to be grammatically correct, one of the terms in the phrase “at on” on line 4 should be removed. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: The phrase “can be delivered” on line 5 should be replaced with the phrase “is deliverable” to match the language used in claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites that the implant body has “a multilayer structure of medical active substance-loaded material with medical active substance concentrations and/or medical active substances differing in layers of the multilayer structure”. Since claim 1 recites that the implant body “contains a medical active substance”, it is unclear if the medical active substance(s) of claim 12 include that of claim 1 or are in addition to that of claim 1. For the sake of examination, the medical active substance(s) of claim 12 is interpreted as including the medical active substance of claim 1. Accordingly, it is suggested to amend claim 12 to recite “wherein the medical active substance comprises at least one medical active substance, and wherein the implant body has a multilayer structure each layer of the structure containing a different concentration of the medical active substance a different medical active substance of the at least one medical active substance
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 10, 11 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arenberg (US Pat 6,685,697).
Re claim 1, Arenberg discloses a patient-specific implant (Fig 5) for insertion into a body cavity of a patient (Col 4, Lines 6-21), 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 body cavity (Col 28, Lines 51-67; Col 29, Lines 18-20), wherein the implant body comprises an outer contour which corresponds predominantly to an inner contour of the body cavity 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).
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 10, Arenberg discloses 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 (Col 9, Lines 35-53).
Re claim 11, Arenberg disclose that the implant body and/or the handle is biodegradable (Col 15, Lines 11-15).
Re claim 14, Arenberg discloses that the implant is adapted for insertion into a round window niche of an ear of the patient (as seen in Fig 4; Col 9, Lines 38-40).
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 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Arenberg (US Pat 6,685,697) in view of Arenberg (US Pat 6,045,528).
Re claim 3, Arenberg ‘697 discloses all the claimed features except that the implant body has a same 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 body cavity (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 to include the implant body with a same 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 body cavity (Col 9, Lines 51-60).
Re claim 4, Arenberg ‘697 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 body cavity (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 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 body cavity (Col 9, Lines 51-60).
Re claim 5, Arenberg ‘697 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 body cavity (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 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 body cavity (Col 9, Lines 51-60).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Arenberg (US Pat 6,685,697) in view of Cline et al. (PG PUB 2016/0199630).
Re claim 6, Arenberg discloses all the claimed features except that the handle is wider than the implant body in an extent predominantly orthogonal to the insertion direction in order to function as a depth stop for avoiding too deep over-insertion of the implant. Cline, however, teaches an implant (Fig 12) comprising an implant body 1201 (Fig 12) and a handle 1202 (Fig 12) that is wider (at portion 1204, Fig 12) than the implant body in an extent predominantly orthogonal to the insertion direction (Para 176) in order to function as a depth stop for avoiding too deep over-insertion of the implant (Para 176) for the purpose of preventing over-insertion of the implant body (Para 176). Therefore, it would have been obvious to modify Arenberg to include handle such that it is wider than the implant body in an extent predominantly orthogonal to the insertion direction, as taught by Oliver, for the purpose of preventing over insertion of the implant body (Para 176).
Re claim 7, Arenberg discloses all the claimed features except that the handle is shaped such that it rests in a form-fit at 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. Oliver, however, teaches an implant (Fig 12) comprising an implant body 1201 (Fig 12) and a handle 1202 (Fig 12) that is shaped (via portion 1204, Fig 12) such that it rests in a form-fit at 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 176) for the purpose of preventing over-insertion of the implant body (Para 176). Therefore, it would have been obvious to modify Arenberg to include handle such that it is shaped to rest in a form-fit at on a constriction at an entry of the body cavity with the implant body reaches a correct implantation depth and a correct position in the body cavity, as taught by Oliver, for the purpose of preventing over-insertion of the implant body (Para 176).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Arenberg (US Pat 6,685,697) in view of Oliver et al. (PG PUB 2012/0089071).
Re claims 8 and 9, Arenberg discloses all the claimed features except a marking by which a spatial position and/or orientation of the implant during implanting in the body cavity is recognizable to a user (as required by claim 8), wherein the marking is arranged on the handle (as required by claim 9). Oliver, however, teaches an implant 200 Fig 4) comprising a handle 208 (Fig 4) comprising a marking 206 (Fig 4) arranged thereon (as seen in Fig 4) by which a spatial position and/or orientation of the implant during implanting in a body cavity is recognizable to a user (Para 78) for the purpose of preventing over-insertion of the implant (Para 78). 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 a marking on the handle, as taught by Oliver, for the purpose of preventing over-insertion of the implant (Para 78).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Arenberg (US Pat 6,685,697) in view of Aebischer (US Pat 5,182,111).
Re claim 12, Arenberg discloses all the claimed features except that the implant body has a multilayer structure of medical active substance-loaded material with medical active substance concentrations and/or medical active substance differing in layers of the multilayer structure. Aebischer, however, teaches an implant 90 (Fig 9) having a multilayer structure of medical active substance-loaded material (as seen in Fig 9, two layers 46 and 48 are formed) with medical active substance concentrations and/or medical active substances differing in layers of the multilayer structure (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 to include the implant body with a multilayer structure with different medical active substances in different layers of the structure, as taught by Aebischer, for the purpose of providing a synergistic effect (Col 6, Lines 29-32).
Re claim 13, Arenberg 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 can be delivered 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 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) or, alternatively, over Arenberg (US Pat 6,685,697) in view of Baum et al. (PG PUB 2024/0091410).
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.
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 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. PG PUB 2021/0228849 to de Juan et al. discloses an inserter with depth limiting means.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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