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 .
This Office Action is in response to the amendments dated May 18, 2026.
Claims 1-6, 8, 12, 38-39, and 41-51 are pending.
Claim 12 was previously withdrawn as being directed to a non-elected invention.
Claim Objections
Claims 45 and 48 are objected to because of the following informalities: the claim drops the “a” before “termination” and “the” before “ear system endoscope”. Appropriate correction is required.
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, 38-39, and 41-48 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. Applicant’s response has not clarified the issue. If anything, the scope of the claim is less clear in light of Applicant’s treatment of the prior art. According to Applicant, devices that are designed to image the inner portions of the ear do not constitute an “ear system endoscope”. The Examiner is still left without any direction as to what an ear system endoscope is and is not. Because of this, a rejection for indefiniteness is proper. 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 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 43 is written in non-standard English as “configured to provide an optical view of at least view a distal end” is not clear. The Examiner assumes that this was intended to be “configured to provide an optical view of at least a distal end of the device”. Appropriate correction is required.
Claim 47 is rejected for referring to “the conduit” without providing proper antecedent basis. Claim 1 does not include a conduit, so this conduit could be referring to something in the ear or in the device. The Examiner assumes that claim 47 was intended to depend from claim 2. 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, 38-39, 42-43, and 46-51 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 ear system endoscope 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 ear system endoscope 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 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 wherein: the device is configured to provide an optical view of 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).
Regarding Claim 46, Kim further discloses wherein: the lumen is in fluid communication with an interior of at least one duct of the duct(s) of the inner ear (functional language; the needle and its conduit can be placed in such a way that the lumen of the conduit is in fluid communication with an interior of at least one duct of the inner ear).
Regarding Claim 47, Kim further discloses wherein: ear system endoscope includes a termination (distal end of device as seen in Fig. 1, for example; see also Paragraph 0050 indicating that the needle and scope may be housed in an elongated shaft where the distal end of that shaft is a termination) in which the conduit is slidably received (no conduit has been previously claimed; Paragraphs 0047 and 0050 indicate that the needle can be selectively deployed through the shaft or that a separate catheter can be within the shaft).
Regarding Claim 48, Kim further discloses wherein: ear system endoscope includes a handle (110) and a means for reaching 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 (elongated tubular body 140).
Regarding Claim 49, Kim discloses:
A device, comprising:
a means for viewing an interior of an ear system of a human (see Paragraph 0045 discussing how the scope includes lens and a light transmission component and that it may be optical);
a means for incising through tissue to reach a duct of an inner ear of a human (see Paragraph 0045-0046, the system includes a needle, and the needle can be sharp); and
a means for delivering therapeutic substance to the duct through a resulting incision that reaches to the duct made by the means for incising (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).
Regarding Claim 50, Kim further discloses means for reaching the duct 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 (elongated tubular body 140).
Regarding Claim 51, Kim further discloses wherein: the device is an ear system endoscope (Kim’s device can image the ear) and the device has a handle (110) configured to enable a user to hold the device while viewing the interior of the ear system of the human (a user can hold the handle 110).
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, 38, 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 ear system endoscope 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 (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 end (see O’Shea – Paragraph 0058 discussing the cutter as a rotatable drill).
Regarding Claim 38, Goldfarb as modified further discloses wherein: the device includes a therapeutics substance delivery apparatus (Goldfarb – see Paragraph 0129 discussing using tools with the device 12 to deliver drugs) and an incisor (O’Shea – see instrument 30 and Paragraph 0058), wherein the incisor is at least one of a drill bit configured to drill through a promontory of a cochlea of a human (O’Shea – see instrument 30 and Paragraph 0058), or a conduit configured to pierce a round window of the human with a fully intact round window niche.
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.
Claims 4 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2020/0094030) in view of Tandon et al. (US 2021/0154452).
Kim discloses the invention substantially as claimed as stated above and wherein: the ear system endoscope includes termination (distal end of device as seen in Fig. 1, for example; see also Paragraph 0050 indicating that the needle and scope may be housed in an elongated shaft where the distal end of that shaft is a termination), but does not explicitly disclose a component or means for fixing a distal end of the device/termination in or proximate to a round window niche of the human. Tandon teaches using a collar (108) to seat the tool in the round window. 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 Kim’s device to include Tandon’s collar. Such a modification helps prevent the tool from overextending into the patient’s anatomy.
Response to Arguments
Applicant's arguments filed May 18, 2026, have been fully considered but they are not persuasive.
Applicant first renews the argument against the Examiner’s Lack of Unity based on an incomplete reading of the rule. 37 CFR 1.475 (“the Rule”) does not make a categorical statement that all national stage applications containing claims to different categories of invention will be considered to have unity of invention as Applicant asserts. The Rule is a conditional statement providing when unity of invention will be found despite multiple categories of invention being claimed. Unity of invention is only found “if” claims are drawn only to one of the combinations of categories listed in the Rule. Applicant has not addressed the rule in its entirety and has not argued that the claims fall within one of the listed combinations. Furthermore, as stated in the last Office Action, the Examiner was not relying on 37 CFR 1.475(b), which Applicant has still not addressed. The Lack of Unity is maintained.
The analogies are not substantive arguments. Claim terminology is given its broadest reasonable interpretation, but when a claim becomes so broad that no structure can be adequately attributed to it, the claim is indefinite. When asked what the scope of the claim is, Applicant’s response is simply that it is what it is. The Examiner is tasked with figuring out what that means and how to apply art to such a standard.
As Applicant’s arguments against the art rejections demonstrate, there is no reasonable standard for determining the metes and bounds of the claim. The Examiner used Kim to reject claim 1. Applicant states that Kim does not anticipate the claim. No argument is provided, just a conclusory statement. Kim is directed to an endoscope with a needle that is positioned in the ear. Applicant does not consider this to be an ear system endoscope. Why not? If an endoscope designed to be inserted into the ear is not an “ear system endoscope”, then what is? Applicant’s statement that the prior art is not what is being claimed supports the Examiner’s assertion that the claim is indefinite. Because the metes and bounds of claims need to be identifiable, and this claim’s metes and bounds are not, the claim is indefinite.
The rejection based on unclaimed essential subject matter was based on an assumption that may be wrong. The Examiner assumed that something in the disclosure is necessary for there to be a patentable invention. Claim 1 fails to include a single structural limitation. Therefore, the essential subject matter has not been claimed. This rejection was intended to highlight the deficiencies of the claim. If the essential elements have been claimed, then what are they? Applicant has still not provided what they are on the record. Even if the particular rationale of failing to include essential subject matter is removed, the claims are still indefinite. The claims are rejected based on the statute, and the statute requires the claims to particularly point out and distinctly claim the subject matter which the inventor(s) regard as the invention. That has not been done.
The rejection of claim 6 was based primarily on the claim’s lack of relating the handheld nature to an element of the claim. The amendment provides some clarity.
Applicant then argues that the rejection of claim 8 is improper by stating that the Examiner did not identify the disclosed components. Applicant has not argued against the 112(f) invocation, so the 112(b) rejection is deemed proper. When a term invokes 112(f), the disclosure or record must be clear as to what structure is associated with the term. As explained in the rejection, that has not been done. Applicant can remedy this by amending the claims so as not to invoke 112(f) or by clarifying the record by identifying the structure related to the terms.
The art related arguments are not substantive as they make mere assertions without providing any reasoning. No attempt was made to explain why the claimed invention is patentably distinct over the prior art. The conclusory statements are not persuasive, and as explained above, further demonstrate the issues with determining the scope of the claims. The anticipation and obviousness rejections are maintained.
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.
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.
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795
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