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 Group I in the reply filed on December 9, 2025, is acknowledged. The traversal is on the ground(s) that the Examiner failed to address 37 CFR 1.475(b). This is not found persuasive because the Examiner did not assert unity was lacking based on the claims being directed to different categories of invention. 37 CFR 1.475(b) applies when an international or a national stage application contains claims to different categories of invention and unity is found under those circumstances set forth in the rule. Here, the Examiner found lack of unity under 37 CFR 1.475(a) because the claims lack the same or corresponding special technical feature. The Examiner also adds the claims lack a shared technical relationship. In either event, Applicant has failed to address the Examiner’s reason for finding lack of unity, and the requirement is maintained.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-6, 8, and 38-44 are addressed on the merits.
Claims 12-17 are withdrawn as being directed to the non-elected invention.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“component” in claims 4 and 8 (“component” is a generic placeholder, is modified by functional language (“configured to fix a distal end of the device in or proximate to a round window niche of the human”) and is not modified by sufficient structure to perform the claimed function). The component is disclosed as 1540.
“component” in claim 8 (“component” is a generic placeholder, is modified by functional language (“configured to rotate relative to the fixed distal end”) and is not modified by sufficient structure to perform the claimed function). The disclosure is not clear as to the structure of this component.
“therapeutic substance delivery apparatus” in claims 39 and 40 (“apparatus” is a generic placeholder, is modified by functional language (“configured to deliver a solid/fluid therapeutic substance to the cochlea”), and is not modified by sufficient structure to perform the claimed function). The disclosure is not clear as to the structure of this component.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-6, 8, and 38-44 are 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. The claims, as discussed in more detail below, fail to set forth the structure of the device being claimed, including the relationship of various features to one another.
Claim 1 is rejected as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the structure of the claimed device. Claim 1 refers to an “ear system endoscope” that is configured to perform a function. The “ear system endoscope” is not a clearly defined structure in itself, and is merely described by its function. What is or what is not within the metes and bounds of the claim is only limited by the function such that a person having ordinary skill in the art would not know the scope of the claim. While breadth is not indefiniteness, the claim lacks any structure for performing the claimed function. What is an “ear system endoscope”? The Examiner is treating the claim as requiring an endoscope with any accompanying tools that can perform the claimed function. Appropriate correction is required.
Claim 2 is also indefinite and highlights the problems with the claim set as a whole. Claim 2 introduces a conduit for performing the claimed incision function. Is this conduit in addition to the ear endoscope system of claim 1 such that there are two elements configured to incise tissue? Is the conduit part of the ear system endoscope, and it is the conduit that is configured to incise tissue? What is the structural relationship between the ear system endoscope and the conduit? The claim is unclear. The Examiner is considering the conduit to either be part of the ear system endoscope or a separate component that can be used with the ear system endoscope. Appropriate correction is required.
Claim 3 presents the same problem as claim 2, but instead of a claimed conduit, there is a claimed drill bit. As above, the Examiner is considering the drill bit to either be part of the ear system endoscope or a separate component that can be used with the ear system endoscope. Appropriate correction is required.
Claim 4 includes a component, this component is “separate from a sharp end of a termination of the device”. This language is indefinite because the claims, again, have failed to set forth the structural relationship of the claim elements. The device is what is being claimed, and the claims have yet to claim that the device has a sharp end of a termination. The claims need to set forth the structure of the device. For example, the device comprises an elongated member, the elongated member having a proximal end and a distal end, and wherein the distal end is sharp. The component can then be said to be separate from the distal end. This is merely an example and is meant to be illustrative of one style of claiming. As currently drafted, the claim is not clear as to what a “sharp end of a termination of the device” means because the only reference to an end is that of a distal end. The Examiner assumes that the claim requires a component configured to fix a distal end of at least one part of the device to a round window niche of the human. Appropriate correction is required.
Claim 6 indicates that the device is “a handheld device” configured to reach within a human as claimed. Does this require a portion of the device to reach the duct(s) as claimed or all the device? The claim is unclear because no structure is part of the device. This could be the ear system endoscope that reaches the duct(s), but that is not clear. Without some structure, the scope of the claim is indeterminate. The Examiner assumes that the scope requires at least some portion of the device to be handheld and at least some portion of the device to be capable of reaching the ducts as claimed. Appropriate correction is required.
Claim limitation “component” in Claim 8 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The term is used throughout the disclosure to refer to various parts, but there is no clear discussion of a component configured to rotate relative to the fixed distal as claimed. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 8 is also indefinite because “relative to the fixed distal” is unclear. The “fixed distal” lacks antecedent basis. The Examiner assumes for examination purposes that this is the fixed distal end. Appropriate correction is required.
Claims 39 and 40 refer to “the therapeutic substance delivery apparatus” without providing proper antecedent basis for the limitation. Claim 39 depends from claim 1, not claim 38. The Examiner assumes that there is only one therapeutic substance delivery apparatus.
Claim limitation “therapeutic substance delivery apparatus” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no clear indication as to what structure constitutes the therapeutic substance delivery apparatus in the disclosure. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 41 recites the limitation "the incisor" and “the drill bit”. There is insufficient antecedent basis for this limitation in the claim. The claim does not depend from claim 38, so it is unclear whether this is a new limitation or not. Claim 1 does not include these limitations. The Examiner assumes that the device of claim 1 includes a drill bit. Appropriate correction is required.
Claim 42 recites the limitation “the incisor” and “the conduit”. There is insufficient antecedent basis for this limitation in the claim. The claim does not depend from claim 38, so it is unclear whether this is a new limitation or not. Claim 1 does not include these limitations. The Examiner assumes that the device of claim 1 includes a chamfered portion of a conduit. Appropriate correction is required.
Claim 43 includes “an optical scope” where it is unclear if this is in addition to the ear system endoscope or part of the ear endoscope system. Because an endoscope is a device to provide internal imaging, the addition of a secondary scope, while known in the art, would not necessarily be part of the same device such that there are two imaging components on the same device. Again, because the claims do not set forth the structural relationships among the components, the scope of the claim is unclear. The Examiner assumes that the device includes at least one optical scope. Appropriate correction is required.
Claim 44 recites the limitation "the incisor" and “the drill bit”. There is insufficient antecedent basis for this limitation in the claim. The claim does not depend from claim 38, so it is unclear whether this is a new limitation or not. Claim 1 does not include these limitations. The Examiner assumes that the device of claim 1 includes a spherical drill bit. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5-6, 38-40, and 42-43 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Kim et al. (US 2020/0094030).
Regarding Claim 1, Kim discloses:
A device, comprising:
an ear system endoscope (100) configured to incise through tissue to reach duct(s) of an inner ear of a human and to deliver a therapeutic substance to the duct(s) through a resulting incision (see Paragraph 0045-0046, the system includes a needle, and the needle can be sharp; see Paragraphs 0044 and 0047 discussing delivering a therapeutic substance through the needle).
Regarding Claim 2, Kim further discloses wherein: the device includes a conduit (needle 180 is a conduit) configured to incise through tissue to reach the duct(s), the conduit having a lumen therein through which the therapeutic substance can be delivered to the duct(s) (see Paragraph 0045-0046, the system includes a needle, and the needle can be sharp; see Paragraphs 0044 and 0047 discussing delivering a therapeutic substance through the needle).
Regarding Claim 5, Kim further discloses wherein: the device includes a conduit with a sharp end configured to pierce a round window of the human to reach the duct(s) of the inner ear (see Paragraph 0045-0046, the system includes a needle, and the needle can be sharp; see Paragraphs 0044 and 0047 discussing delivering a therapeutic substance through the needle).
Regarding Claim 6, Kim further discloses wherein: the device is a handheld device (see Fig. 2, for example, showing the handheld nature of the device) configured to reach the duct(s) via a route that extends through a tympanic membrane and then across a middle ear to at least one of a promontory within a middle ear of the human or a round window niche of the human (functional language; the device can be used as claimed, see Fig. 2 showing insertion into the ear; see also Paragraph 0054)).
Regarding Claim 38, Kim further discloses wherein: the device includes a therapeutics substance delivery apparatus (see Paragraph 0045 indicating that there is a reservoir and a dispensing mechanism and Paragraph 0050 indicating that the device may have a catheter as part of the system that is separate from the needle) and an incisor (sharp needle discussed in Paragraph 0046), wherein the incisor is at least one of a drill bit configured to drill through a promontory of a cochlea of a human, or a conduit (needle 180) configured to pierce a round window of the human with a fully intact round window niche (the needle is sharp and can pierce tissue).
Regarding Claim 39, Kim further discloses wherein: the therapeutic substance delivery apparatus is configured to deliver a solid therapeutic substance to the cochlea (see Paragraph 0050 indicating that the device may include a sponge applicator; see also Paragraph 0042 discussing intracochlear administration).
Regarding Claim 40, Kim further discloses wherein: the therapeutic substance delivery apparatus is configured to deliver a fluid therapeutic substance to the cochlea (see Paragraph 0052 indicating that the composition can be liquid or gas; see also Paragraph 0042 discussing intracochlear administration).
Regarding Claim 42, Kim further discloses wherein: the incisor is a chamfered portion of the conduit (needle 180 may have a beveled tip; see Paragraph 0046); and the device is configured to deliver the therapeutic substance through the conduit (see Paragraph 0052 indicating that the composition goes through the needle).
Regarding Claim 43, Kim further discloses an optical scope configured to at least view a distal end of the device (see Paragraph 0045 discussing how the scope includes lens and a light transmission component and that it may be optical).
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, 4, 8, 41, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Goldfarb et al. (US 2007/0293726) in view of O’Shea et al. (US 2021/0059859).
Regarding Claim 1, Goldfarb discloses:
A device, comprising:
an ear system endoscope (12) configured to deliver a therapeutic substance to the duct(s) through a resulting incision (see Paragraph 0129 discussing drug delivery).
Goldfarb does not explicitly disclose configuring the endoscope to incise through tissue to reach duct(s) of an inner ear of a human. Goldfarb does indicate that a variety of working device can be used with the system including instruments or other devices useable to perform or facilitate a therapeutic or diagnostic task (see Paragraph 0129). O’Shea teaches using one such instrument (cutting instrument 30) to resect tissue within the ear. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Goldfarb’s device to include a cutting instrument as taught by O’Shea. Such a modification provides a means for resecting or cutting tissue.
Regarding Claim 4, Goldfarb as modified further discloses wherein: the device includes a component (Goldfarb – 110; see Figs. 12-13B showing the hooked distal end of 110; see also Paragraph 0101 explicitly stating that there can be a plurality of channels) configured to fix a distal end of the device in or proximate to a round window niche of the human, which component is separate from a sharp end of a termination of the device (the hooked end of the tool 110 can be used as claimed because it has the same structure as Applicant’s hooked tool). The Examiner notes that because Goldfarb explicitly states that more than one channel can be used with the device, the inclusion of two channels is obvious and the use of different tools in each channel would also be obvious as this would allow for more than one function to be performed at the target site. O’Shea’s cutting element is used to cut while the hooked tool is used to guide. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include two channels with two tools for two different purposes as discussed in Goldfarb and O’Shea. Such a configuration allows for more than one function to be performed at the target site under endoscopic visualization.
Regarding Claim 8, Goldfarb as modified further discloses wherein: the device includes a component configured to fix a distal end of the device in or proximate to a round window niche of the human (Goldfarb – 110; see Figs. 12-13B showing the hooked distal end of 110; see also Paragraph 0101 explicitly stating that there can be a plurality of channels; the hooked end of the tool 110 can be used as claimed because it has the same structure as Applicant’s hooked tool); and the device includes a component configured to rotate relative to the fixed distal (see O’Shea – Paragraph 0058 discussing the cutter as a rotatable drill).
Regarding Claim 41, Goldfarb as modified further discloses wherein: the incisor is the drill bit (see O’Shea – Paragraph 0058 discussing the cutter as a drill).
Regarding Claim 44, Goldfarb as modified further discloses wherein: the incisor is the drill bit, and the drill bit is a spherical drill bit (see O’Shea’s drill 32 in Figs. 11-13; see Conclusion for additional spherical drill bits).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Goldfarb et al. (US 2007/0293726) in view of O’Shea et al. (US 2021/0059859), as applied to claim 1 above, and further in view of Auth (US 4,445,509).
Goldfarb and O’Shea disclose the invention substantially as claimed as stated above. O’Shea further discloses the cutting element being a drill (Paragraphs 0058-0059) including one or two lumens in the drill, but the details are not shown (see Paragraph 0060). Auth teaches a medical drill with a lumen in the bit (See Fig. 5, lumen 40 and outlet 24) for adding therapeutic matter to the body space (see Abstract and Col 7 Lines 62-63). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Goldfarb and O’Shea’s device to include Auth’s channel location. Such a modification provides a space efficient means for adding and/or removing fluid to and from the body space.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Spherical drill bits are well-known in the art – see Cragg et al. (US 6,740,090) Fig. 23.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795