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 . Claims 1-29 & 56 are pending and examined below.
Election/Restrictions
Applicant’s election without traverse of Group I: claims 1-29 & 56 in the reply filed on 09/05/2025 is acknowledged.
Claims 20-55 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/05/2025. The requirement is therefore made FINAL.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
-1201 in Fig. 43
-38 in Fig. 62C.
The drawings are objected to because:
-Figs. 8, 9, 10, 18, 27, 28, 45A, 50A & B, 59B, & 63A & B, the reference numbers/words are too light and hard to identify.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 10 objected to because of the following informalities: It appears claim 10 has a typographical error in “though”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-29 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.
Claims 1 & 29, recites the limitation “the application of force” in the last line. There is insufficient antecedent basis for this limitation in the claim.
Claims 10 & 23, recites the limitation “the anchor”. It is unclear if this is referring to the distal anchor or the anchor body. For the purpose of examination, it is considered the distal anchor.
Claims 14, recites the limitation “wherein the anchor body comprises a heel and a toe retainer”. It is unclear of how the anchor body comprises a toe retainer when the figure 49A appears to depict the “toe retainer” on an anchor delivery element and not on the anchor body [0135]. Accordingly, the examiner cannot examine claim 14 with prior art until clarification is made.
Claim 26, recites the limitation “the force applied by the tension element” in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not mention any force applied by the tension element, it only mentions a force applied to the elongate body. Accordingly, the examiner cannot examine claim 26 with prior art until clarification is made.
Claim 29, recites the limitation “the distal anchor body” in line 6. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is the distal anchor or the anchor body. For the purpose of examination, it is considered the anchor body.
All dependent claims are likewise rejected.
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.
Claim(s) 1-7, 10-12, 16-18, 21, 23, 27-29, & 56 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosenthal et al. (2016/0058556) hereinafter, Rosenthal.
Regarding claim 1, Rosenthal teaches a device (Fig. 3A) for manipulating a tissue in a subject (¶0065) comprising:
a tension element (32, Fig. 3A), the tension element comprising an elongate body (body of 32, Fig. 3A) having a proximal end (70, Fig. 3A, ¶0075) and a distal end (72, Fig. 3A, ¶0071);
a distal anchor (see annotated Fig. 3A below) at the tension element distal end (72, Fig. 3A, ¶0071) comprising an anchor body (see annotated Fig. 3A below), and a pivot point (see annotated Fig. 3A below), and having an insertion configuration (Fig. 7) and a deployed configuration (Fig. 10A), wherein
the distal anchor (see annotated Fig. 3A below) is configured to swivel at the pivot point (arrows 342a and 342b in Fig. 8 show the movement, ¶0089) from the insertion configuration (Fig. 7) to the deployed configuration (Fig. 10A) upon the application of force to the elongate body (implant may be advanced (pushed) into body tissue by an actuator/plunger, ¶0089).
Regarding claim 2, Rosenthal teaches
wherein the tension element has a tensile strength ranging from about 100 MPa to about 600 MPa (greater than 50 MPa, ¶0078).
Regarding claim 3, Rosenthal teaches
wherein the tension element comprises a biodegradable material (¶0102).
Regarding claim 4, Rosenthal teaches
wherein the biodegradable material comprises a biodegradable polymer (¶0102).
Regarding claim 5, Rosenthal teaches
herein the biodegradable polymer is selected from the group consisting of LPLA (Poly(L-lactide)), DLPLA (Poly(DL-lactide)), LDLPLA (Poly(DL-lactide-co-L-lactide)), LPLA-HA (Poly(L-lactide) with hydroxylapatite), PGA (Poly(glycolide)), PGA-TMC (Poly(glycolide-co-trimethylene carbonate) or polyglyconate), PDO (Poly(dioxanone)), LPLG (Poly(L-lactide-co-glycolide)), DLPLG (Poly(DL-lactide-co-glycolide), and copolymers and blends thereof (¶0102).
Regarding claim 6, Rosenthal teaches
wherein the tension element comprises PDO (Poly(dioxanone)) (¶0102).
Regarding claim 7, Rosenthal teaches
wherein the tension element is configured to degrade after about six months (¶0104).
Regarding claim 10, Rosenthal teaches
wherein the anchor in its deployed configuration prevents passage of the distal end of the tension element back though tissue (¶0074 & 0089).
Regarding claim 11, Rosenthal teaches
wherein the anchor body (see annotated Fig. 3A below) comprises a plurality of arms (76a & 76b, Fig. 3A).
Regarding claim 12, Rosenthal teaches
wherein the plurality of arms (76a & 76b, Fig. 3A) swivel at the pivot point (see annotated Fig. 3A below) upon the application of force to the elongate body (implant may be advanced (pushed) into body tissue by an actuator/plunger, ¶0089).
Regarding claim 16, Rosenthal teaches
wherein a plurality of proximal anchors (top 80a & 80b, Fig. 3A) are disposed between the distal anchor and the proximal end of the tension element (32, Fig. 3A).
Regarding claim 17, Rosenthal teaches
wherein the distal anchor and the plurality of proximal anchors are the same type of anchor (¶0075).
Regarding claim 18, Rosenthal teaches
wherein the distal anchor and the plurality of proximal anchors are different types of anchors (¶0075).
Regarding claim 21, Rosenthal teaches
further comprising an anchor delivery element (300, Fig. 4A) coupled to the distal anchor (Fig. 6A), the anchor delivery element comprising a cutting tip (314, Fig. 4A) and configured to pass the distal anchor through the tissue in its insertion configuration (¶0081).
Regarding claim 23, Rosenthal teaches
wherein the anchor delivery element comprises a seating region configured to removably secure the anchor to the anchor delivery element (see annotated Fig. 6A).
Regarding claim 27, Rosenthal teaches
wherein the tissue is a nasal tissue, a throat tissue, or an ear tissue (Fig. 1).
Regarding claim 28, Rosenthal teaches
wherein the nasal tissue comprises nasal septal cartilage, lateral nasal cartilage, major alar cartilage, minor alar cartilage, alar fibrofatty tissue, nasal bone, or a nasal turbinate (Figs. 1-2).
Regarding claim 29, Rosenthal teaches a device (Fig. 3A) for manipulating a tissue in a subject (¶0065), comprising:
a tension element (32, Fig. 3A), the tension element comprising an elongate body (body of 32, Fig. 3A) having a proximal end (70, Fig. 3A, ¶0075) and a distal end (72, Fig. 3A, ¶0071);
a distal anchor (see annotated Fig. 3A below) at the tension element distal end (72, Fig. 3A, ¶0071) comprising an anchor body (see annotated Fig. 3A below) and a pivot point (see annotated Fig. 3A below), and having an insertion configuration (Fig. 7) and a deployed configuration (Fig. 10A), wherein
the distal anchor body (see annotated Fig. 3A below) comprises a plurality of arms (76a & 76b, Fig. 3A), and the plurality of arms are configured to swivel at the pivot point (arrows 342a and 342b show the movement, ¶0089) from the insertion configuration to the deployed configuration upon the application of force to the elongate body (implant may be advanced (pushed) into body tissue by an actuator/plunger, ¶0089).
Regarding claim 56, Rosenthal teaches a device (Fig. 3A) for manipulating a tissue in a subject (¶0065) comprising:
a tension element (32, Fig. 3A), the tension element comprising an elongate body (body of 32, Fig. 3A) having a proximal end (70, Fig. 3A, ¶0075) and a distal end (72, Fig. 3A, ¶0071);
a distal anchor (see annotated Fig. 3A below) at the tension element distal end comprising an anchor body (see annotated Fig. 3A below) having a surface area, an insertion configuration (Fig. 7), and a deployed configuration (Fig. 10A), wherein
the distal anchor (see annotated Fig. 3A below) in the deployed configuration (Fig. 10A) has a larger surface area for opposing tissue than the distal anchor in the insertion configuration (Fig. 7).
Claim Rejections - 35 USC § 103
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 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(s) 8-9, 19, & 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenthal in view of Krespi et al. (US 20190029872 A1) hereinafter, Krespi
Regarding claim 8, Rosenthal does not teach the tension element has a length ranging from about 10 cm to about 20 cm. However, Krespi teaches suspension implants designed to lift, suspend and stiffen a patient's soft palate and/or uvula (¶0002)
wherein the tension element has a length ranging from about 10 cm to about 20 cm (between 1 and 30 centimeters, ¶0061, Krespi).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Rosenthal by incorporating the teachings above as taught by Krespi in order to shorten and stiffen the patient's soft palate for lifting and raising (¶0060, Krespi).
Regarding claim 9, Rosenthal does not teach the tension element has a length of about 15 cm. However, Krespi teaches
wherein the tension element has a length of about 15 cm (between 1 and 30 centimeters, ¶0061, Krespi).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Rosenthal by incorporating the teachings above as taught by Krespi in order to shorten and stiffen the patient's soft palate for lifting and raising (¶0060, Krespi).
Regarding claim 19, Rosenthal does not teach an enlarged distal tip. However, Krespi teaches
wherein the distal end (26, Fig. 3, Krespi) of the tension element further comprises an enlarged distal tip (29, Krespi).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Rosenthal by incorporating the teachings above as taught by Krespi in order to attach to the needle attachment to allow the suspension implant 20 to be inserted into the patient's soft palate 42 without the suspension implant 20 having to be folded over (Fig. 16, ¶0065, Krespi).
Regarding claim 22, Rosenthal does not teach a keyhole. However, Krespi teaches
wherein the anchor delivery element comprises a keyhole (54, Fig. 16) shaped to removably couple the distal anchor to the anchor delivery element (¶0066, Krespi).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Rosenthal by incorporating the teachings above as taught by Krespi in order to easily attach (the anchor) to the needle and detached once the needle has been inserted into the patient's tissue (¶0066, Krespi).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenthal in view of Gonzales et al. (US 20110251634 A1) hereinafter, Gonzales.
Regarding claim 13, Rosenthal does not teach the anchor body is rectangular in shape. However, Gonzales teaches a device configured for suspending a nasal valve (abstract, Gonzales)
wherein the anchor body (110, Fig. 1, Gonzales) is rectangular in shape (Fig. 1, Gonzales).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Rosenthal by incorporating the teachings above as taught by Gonzales in order to exerts the desired amount of tension (on the nose cartilage) (¶0021, Gonzales).
Claim(s) 15, 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenthal in view of Feezor et al. (US 20200078194 A1) hereinafter, Feezor.
Regarding claim 15, Rosenthal does not teach the anchor body has a dog-bone shape. However, Feezor teaches cartilage support implants for nasal valve support (abstract, Feezor)
wherein the anchor body has a dog-bone shape (500, Fig. 6, Feezor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Rosenthal by incorporating the teachings above as taught by Feezor in order to reduce symptoms of nasal valve collapse (¶0020, Feezor).
Regarding claim 24, Rosenthal does not teach the seating region has a height that is level with a height of the distal anchor. However, Feezor teaches
wherein the seating region has a height that is level with a height of the distal anchor when the distal anchor is seated on the anchor delivery element (Fig. 16F, Feezor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Rosenthal by incorporating the teachings above as taught by Feezor in order to facilitate retention of the implant (¶0116, Feezor).
Regarding claim 25, Rosenthal does not teach a release tab. However, Feezor teaches
wherein the seating region comprises a release tab (1530, Fig. 16D, Feezor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Rosenthal by incorporating the teachings above as taught by Feezor in order to hold the elongate body 1402 in the expanded configuration (¶0115, Feezor).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenthal in view of Morency et al. (US 20030149447 A1) hereinafter, Morency.
Regarding claim 20, Rosenthal does not teach a proximal needle. However, Morency teaches a barbed surgical suture is configured to grip the tissue through which it is inserted (abstract, Morency)
further comprising a proximal needle (29, Fig. 1A, Morency) removably attached to the proximal end of the elongate body of the tension element (¶0046, Morency).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Rosenthal by incorporating the teachings above as taught by Morency in order to secure the suture as a needle is a known apparatus in the art.
PNG
media_image1.png
525
564
media_image1.png
Greyscale
PNG
media_image2.png
395
552
media_image2.png
Greyscale
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIA XIONG WHITE whose telephone number is (703)756-4773. The examiner can normally be reached 0830-1630 EST.
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, Jerrah Edwards can be reached at (408) 918-7557. 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.
/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774