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
Claims 1-3, 6-8, and 12-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 03, 2026. Applicant's election with traverse of the invention of claims 28-34 in the reply filed on August 03, 2026 is acknowledged. The traversal is on the ground(s) that “Art Unit 3783 has not established a prima facie case of restrictability, and instead has merely demonstrated that we are conforming to the rules promulgated by the USPTO” (Remarks page 4, detailed throughout). This is not found persuasive.
Regarding the argument that “Art Unit 3783’s own rules are not followed, because the ‘will be’ is not addressed”, specifically with regard to 37 CFR 1.475(b) and the language in the Restriction Requirement mailed 06/02/26 that “a national stage application…will be considered to have unity of invention” (Remarks, pages 2-3), the examiner respectfully disagrees.
The Restriction Requirement states on pages 2-3:
“As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).”
In this application, the claims are not drawn only to any one of the stated combinations of categories. Applicant has not presented any arguments that the claims fall within one of the combinations of categories. Therefore, unity of invention may not be present in the claims.
The Restriction Requirement on page 2 additionally states:
“As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.”
As detailed in the Restriction Requirement on page 3, the groups of invention (I-III) lack unity of invention because even though the inventions of these groups require the technical feature of a unique surgical guide for an ear canal, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Clifford et al. (USPN 8849394).
The examiner’s reason for finding a lack of unity was because the groups of inventions lack the same or corresponding special technical feature; and Applicant has not addressed the Examiner’s reason for finding lack of unity.
The requirement is still deemed proper and is therefore made FINAL.
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 29 and 32 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.
Claim 29 recites the limitation "the hollow portion of the hollow medical component" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Further regarding claim 29, the limitation “a change of state from that in which it was during flowing” in line 5 renders the claim indefinite. It is unclear what structure “it” is referring to. For examination purposes, “it” has been interpreted as “the flowing substance”. It is suggested to amend this limitation to “a change of state from that in which the flowing substance was during flowing”, or similar.
Regarding claim 32, the limitation “most of its length” in line 2 renders the claim indefinite. It is unclear what structure “it” is referring to. For examination purposes, “it” has been interpreted as “the hollow medical component”. It is suggested to amend this limitation to “…most of a of the hollowing medical component”, or similar.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 28-31 and 33-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clifford et al. (USPN 8849394).
Regarding claim 28, Clifford discloses an apparatus (Figures 12-13B and 16), comprising:
a hollow medical component (working channel 104 of guide block 100 and associated insertable tools, such as PE tube 204: “The working channel 104 is also the conduit for delivering the combined TM penetrator and delivery device 200 near the target tissue region. The working channel 104 is also the conduit for delivering the targeting apparatus near the target tissue region. The distal end of the working channel 104 can be tapered down to prevent the insertion of auxiliary devices past the distal end of the working channel so as to prevent any accidental damage to the TM.” [Col 8, lines 24-34]); and
a support structure (foam block 102 and impression material 120) distinct from the hollow medical component (Figure 12-16) and supporting the hollow medical component (Figure 13A-B), the support structure being configured to interface with an interior of a unique ear canal of a specific human and support the hollow medical component in a fixed trajectory relative to a target in a middle ear of the specific human (“The foam block 102 can be dimensioned to have different outer diameters (e.g., at 2 mm increments from about 3 mm to about 13 mm) to fit different size ear canals of adult patients as well as pediatric patients. The foam block's thickness is selected to take up a minimum amount of axial space within the ear canal while providing enough thickness to provide a relatively secure initial placement within the car canal, act as a dam for the impression material.” [Col 7, lines 26-35]; “Impression material 120 fills in around the guide block system to secure it in place. The foam disk 102 is placed lateral of the TM 12 and within the bony or cartilaginous structure of the car canal. The impression material 120 is injected into the car canal around the tubes of the guide block, filling the ear canal and extending into the concha or the outer ear. The impression material 120 helps stabilize the guide block with respect to the TM. The working space 150 between the guide block 100 and the TM 12 can be filled with the iontophoresis solution.” [Col 9, lines 12-21]).
Additionally regarding claim 28, Clifford discloses an apparatus (Figure 51A-B), comprising:
a hollow medical component (working channel 104, unlabeled in Figure 51A-B see Figure 4 for example and associated insertable tools, such as PE tube 204: “The working channel 104 is also the conduit for delivering the combined TM penetrator and delivery device 200 near the target tissue region. The working channel 104 is also the conduit for delivering the targeting apparatus near the target tissue region. The distal end of the working channel 104 can be tapered down to prevent the insertion of auxiliary devices past the distal end of the working channel so as to prevent any accidental damage to the TM.” [Col 8, lines 24-34]); and
a support structure (“a coiled spring” [Col 12, line 5]) distinct from the hollow medical component and supporting the hollow medical component (Figures 51A-B), the support structure being configured to interface with an interior of a unique ear canal of a specific human and support the hollow medical component in a fixed trajectory relative to a target in a middle ear of the specific human (“FIGS. 51A-B illustrate the use of coil springs that are used to stabilize the guide block tubes within the ear canal. As can be seen in FIGS. 51A-B, a coiled spring are dimensioned to fit in the ear canal, whereby the restorative force of the spring tries to maintain the cylindrical shape, thus stabilizing the guide block system in the ear canal.” [Col 12, lines 3-8]).
Regarding claim 29, Clifford discloses the apparatus of claim 28, further comprising: a flow channel (fill nozzle 130) fluidically isolated from the hollow portion of the hollow medical component (Figure 12; “The fill nozzle 130 is used to deliver the impression material. The fill nozzle 130 can be placed external to or near the inside of the ear canal. The fill nozzle 130 can have a large bore and a tapered distal end, so as to ensure a complete fill of the ear canal space around the guide block by maximizing the velocity and momentum of the impression material 120 as it leaves the fill nozzle 130. Alternatively, the fill nozzle 130 can be placed deeper in the ear canal and retracted as the ear canal fills with the impression material, so as to ensure a complete fill by filling in the ear canal from next to the foam disk 102 first.” [Col 9, lines 21-31]), the flow channel being configured to channel a flowing substance (impression material) to locations outboard of the hollow medical component to establish the support structure, the flowing substance being a substance that, upon a change of state from that in which it was during flowing, enables the support structure to fix the trajectory of the medical component (“The guide block 100 can be stabilized within the ear canal 10 by the insertion of a hardenable material 120 about the guide block. The injectable material 120 has a workable state allowing adjustment to alignment between the guide block support structure and the target tissue of the ear. The injectable material 120 also has a hardened state for stabilizing the guide block support structure relative to the target tissue” [Col 6, lines 8-15]; “Impression material 120 fills in around the guide block system to secure it in place. The foam disk 102 is placed lateral of the TM 12 and within the bony or cartilaginous structure of the car canal. The impression material 120 is injected into the car canal around the tubes of the guide block, filling the ear canal and extending into the concha or the outer ear. The impression material 120 helps stabilize the guide block with respect to the TM.” [Col 9, lines 12-20]).
Regarding claim 30, Clifford discloses the apparatus of claim 28, wherein: the support structure is an uncollapsible stable stent (“a coiled spring” [Col 12, line 5]; “FIGS. 51A-B illustrate the use of coil springs that are used to stabilize the guide block tubes within the ear canal. As can be seen in FIGS. 51A-B, a coiled spring are dimensioned to fit in the ear canal, whereby the restorative force of the spring tries to maintain the cylindrical shape, thus stabilizing the guide block system in the ear canal.” [Col 12, lines 3-8]).
Regarding claim 31, Clifford discloses the apparatus of claim 28, wherein: the support structure is a form-in-place elongated seal (impression material 120; Figure 16; “The guide block 100 can be stabilized within the ear canal 10 by the insertion of a hardenable material 120 about the guide block. The injectable material 120 has a workable state allowing adjustment to alignment between the guide block support structure and the target tissue of the ear. The injectable material 120 also has a hardened state for stabilizing the guide block support structure relative to the target tissue” [Col 6, lines 8-15]; “Impression material 120 fills in around the guide block system to secure it in place. The foam disk 102 is placed lateral of the TM 12 and within the bony or cartilaginous structure of the car canal. The impression material 120 is injected into the car canal around the tubes of the guide block, filling the ear canal and extending into the concha or the outer ear. The impression material 120 helps stabilize the guide block with respect to the TM.” [Col 9, lines 12-20]).
Regarding claim 33, Clifford discloses the apparatus of claim 28, wherein: the hollow medical component (working channel 104) is a surgical guide or a termination (“The working channel 104 is the conduit for the delivery of iontophoresis solution, the iontophoresis electrode, and the injection of irrigation solution. The working channel 104 is also the conduit for delivering the combined TM penetrator and delivery device 200 near the target tissue region. The working channel 104 is also the conduit for delivering the targeting apparatus near the target tissue region. The distal end of the working channel 104 can be tapered down to prevent the insertion of auxiliary devices past the distal end of the working channel so as to prevent any accidental damage to the TM.” [Col 8, lines 24-34]).
Regarding claim 34, Clifford discloses the apparatus of claim 28, wherein: the apparatus is configured to enable the hollow medical component (working channel 104 of guide block 100 and insertable PE tube 204) to move in an axial direction relative to the support structure (“Once the TM has been penetrated, the lance 202 can be retracted so as to deploy the PE tube 204 (FIG. 9)…After the delivery of the PE tube, the combined TM penetrator and delivery device 200 is removed as illustrated in FIG. 10, and thereafter the stabilizing material and the guide block are also removed, thus leaving the PE tube 204 in place in the TM, as illustrated in FIG. 11.” [Col 6, line 60 – Col 7, line 5]).
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.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Clifford et al. (USPN 8849394) in view of Tandon et al. (US 20210154452).
Regarding claim 32, Clifford discloses the apparatus of claim 28, wherein: the hollow medical component (working channel 104 of guide block 100 and associated insertable tools, such as PE tube 204: “The working channel 104 is also the conduit for delivering the combined TM penetrator and delivery device 200 near the target tissue region. The working channel 104 is also the conduit for delivering the targeting apparatus near the target tissue region. The distal end of the working channel 104 can be tapered down to prevent the insertion of auxiliary devices past the distal end of the working channel so as to prevent any accidental damage to the TM.” [Col 8, lines 24-34]) extends along a first axis for most of its length (Figures 4, 13A, 16, and 51A-B).
Clifford fails to explicitly disclose the hollow medical component extends along a first axis for most of its length, and then, at a distal portion thereof, extends in a direction away from the first axis.
Tandon teaches an apparatus (handpiece 100) comprising a hollow medical component (tip portion 106 having channel 300) that extends along a first axis for most of its length (Figure 2), and then, at a distal portion thereof, extends in a direction away from the first axis (Figures 1-2; “The distal portion of the tip portion 106 can be angle.” [0041]), see all of [0041]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the hollow medical component of Clifford to extend along a first axis for most of its length, and then, at a distal portion thereof, extend in a direction away from the first axis based on the teachings of Tandon ensure that the apparatus can be utilized for trans-round window membrane drug delivery in order to improved localized drug delivery to the inner ear (Tandon [0003], [0041]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights