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 with traverse of species IX, Figure 19, in the reply filed on June 29, 2026, is acknowledged. The traversal is on the grounds that “will be” considered to have unity of invention is not addressed (Applicant’s reply of June 29, 2026: page 3). This is not found persuasive because the Office action of April 29, 2026, requires an election of species rather than a category (e.g., product, process, apparatus, etc.). The previous examiner evidently included paragraph 2 of said Office action in order to present an appropriate definition for “special technical features”, and Applicant has not specified any claimed “special technical feature” supposedly lacking in Sacherman et al., US 2019/0321611 A1, discussed in detail below. Therefore, no further comment is necessary and the requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 9 and 38 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). In claims 9 and 38, the “tissue interface portion” and “component” in combination with anatomical portions of a human encompasses a human organism; it is recommended that “has been implanted” (claim 9, line 3) be replaced with functional language such as --is configured to have been implanted-- and “was implanted” (claim 9, line 5) be replaced by --is configured to be implanted-- or similar language and that like revisions also be made to claim 38 in order to avoid positive recitation of human body parts as elements of an assembly or device.
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.
Claims 1-3, 6, 8-10, 31-32, 34, and 36-38 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. In claim 1, line 7, “the barrier” lacks a proper antecedent basis. In claim 6, line 4, “the septum” lacks a proper antecedent basis. In claim 31, line 9, “the barrier” lacks a proper antecedent basis. In claim 36, line 4, “the septum” lacks a proper antecedent basis.
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 1-3 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 10-11, 15, 17, and 24 of U.S. Patent No. 12,121,415. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant limitations are evident from said claims of the patent. A second member or component mates with an annular member of a first member or tissue interface portion “to form a fluidic seal” patent claim 5, with each element having a lumen or passage for delivering drugs into a body chamber (patent claim 1), which may be an inner ear with an opening through which first member or tissue interface portion is inserted (patent claim 17); attention is also directed to patent claims 15 and 24 (“removing the second member from the lumen”, at line 2).
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 1-3, 6, 8-16, 20, 31-32, 34, and 36-38 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Sacherman et al., US 2019/0321611 A1, which discloses a tissue interface portion configured for engagement and securement to a natural round window 25 proximate an inner ear of a human and for providing a passage from outside the inner ear to inside the inner ear (Figures 2-5, 9A-9B, 10C-10K, 14, 16, 18, 22-23, 24A, 24H, 26; abstract; paragraphs 0009, 0011-0012, 0100+, 0127-0128) and a component releasably attached to and removable from the tissue interface portion, which is removably permanently fixed to a barrier (such as a round window or a wall) establishing the inner ear of a human (paragraphs 0007, 0009, 0050, 0090-0091, 0097, 0100, 0103-0106, 0112, 0117; MPEP § 2114). The component at least partially seals the passage (paragraphs 0010, 0075) and provides passive features such as delivering or conveying therapeutic substances (paragraphs 0008, 0010, 0050, 0066, 0083, 0087) and functioning as an artificial round window (paragraphs 0010, 0064, 0075, 0079, 0090).
Regarding claim 6, the device further comprises a guide for leading a syringe tip to a septum [Figures 12E (refill cannula 120b), 26 (needle 131); paragraphs 0072, 0093, 0095, 0118-0119]. Regarding claims 8, 15, and 37, the device is capable of receiving a water-based substance natural to the inner ear (paragraphs 0062, 0124, 0126), and an increased internal pressure of the delivery apparatus or component results in delivery of the therapeutic substance into the inner ear (paragraphs 0093, 0096, 0113). Regarding claims 9 and 38, the tissue interface portion is structurally capable of being implanted into bone for at least two years, and the component is likewise capable of being implanted for at least eighteen months less (paragraphs 0091, 0097, 0100, 0103-0106, 0112), whether or not such was the intended purpose of the device (MPEP § 2114). Regarding claim 10, the component completely sealing the passage of the tissue interface portion is innate from the materials used and the dissimilar fluids naturally present in the inner and middle ears [paragraphs 0010, 0075 (“sealing between the device and the surrounding tissues”), 0079-0081]; moreover, “seal” is broad enough to encompass “to close or make secure against access, leakage, or passage by a fastening or coating” (Merriam-Webster’s Collegiate Dictionary, 10th ed.: 1996). Regarding claims 11 and 20, according to line 6 of claim 11, only one of the three clauses that follow need be met, and the limitations of at least the first and third clauses are met, as explained above. Regarding claims 2-3, 12-13, 32, and 34, the component functioning as an artificial round window and as a passive drug-release device, along with having the sealing and detachable features, are likewise demonstrated above. Regarding claims 14 and 16, the functional component is and has a self-healing septum in that is fillable or refillable with therapeutic agents kept separate from surrounding tissue and from other structures of the device; attention is also directed to the resealing feature of a reservoir (paragraphs 0095, 0119). Regarding claim 31, the removable seal apparatus configured to unsealably seal the passage through the tissue interface portion is viewed as the pressure relief valve 111 (Figures 2-4; paragraph 0096) or the access port 125 (Figures 2-3, 6A-6B, 7; paragraph 0095). Regarding claim 36, the rigid construction of the reservoir and other components in some embodiments (Figures 2-3, 6A-6B, 10J-10K, 14, 26; paragraphs 0081, 0093) prevents over-insertion of the syringe tip.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David H. Willse, whose telephone number is 571-272-4762. The examiner can normally be reached on Monday through Thursday. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Melanie Tyson can be reached at telephone number 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID H WILLSE/ Primary Examiner, Art Unit 3774
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