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 .
Detailed Action
This is in response to the preliminary amendment filed 01/23/2026
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 31-47 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 12,083,034
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 12 generally recites a system and method which includes an elongate tension element, a delivery device, anchor delivery element, actuator, a cannula having a curved distal end and an atraumatic tip, which is generally recited in claims 31-62 of the application.
It is clear that all the elements of claims 31-47 are to be found in claim 17. The difference between claims 31-37 of the application and claim 12 of the patent lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus the invention of claim 12 of the patent is in effect a “species” of the “generic” invention of claims 31-37. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 31-37, 45-47, 48-53, 57-59, 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0058556 (Rosenthal et al.) in view of U.S. Patent Publication Number 2002/0077598 (Yap et al.) and U.S. Patent Publication Number 2011/0118779 (Olien et al.), U.S. Patent Publication Number 2014/0074238 (Abbate et al.)
Regarding claims 31-35, 45-47 Rosenthal et al. discloses as shown Figures 3A, 3B, 4A, a system for shaping one or more tissues comprising; an elongate tension element (implant 32, see paragraphs [0061], [0065]) comprising a distal anchor and a proximal end, the distal anchor comprising one or more arms (arm 76a, 76b); an anchor delivery element (needle 312, see paragraph [0081]) coupled to the distal anchor; and an actuator (actuator 306, see paragraph [0081]), wherein the anchor delivery element is coupled to the one or more arms of the distal anchor, wherein a distal end of the one or more arms is beveled, wherein the tension element comprises a plurality of proximal anchors (ridges, see paragraph [0016]) between the distal anchor and the proximal end, wherein the one or more tissues comprises a nasal septal tissue, wherein the one or more tissues comprises a nasal turbinate tissue, wherein the one or more tissues comprises a throat tissue or a soft palate
Rosenthal et al. fails to disclose the actuator is capable of advancing the anchor delivery the anchor delivery element with the distal anchor coupled thereto through the distal end of the cannula and through the one or more tissues, a cannula comprising a curved distal end and a sharp tip.
To be clear, the Office interprets needle 312 coupling implant 32 to actuator 306, because the implant 32 is disposed within needle 312, which is directly coupled handle 302, which is movably coupled to actuator 306. Thus, needle 312 indirectly couples implant 32 to actuator 306, via the handle.
Rosenthal et al. fails to disclose the actuator is capable of advancing the anchor delivery element into tissue with a deployed force that is greater than an applied force by a user.
Yap et al., from a related field of endeavor teaches a similar system as show in Figure 1, where the actuator (motor, plunger, see paragraph [0085]) is capable of advancing a delivery element into tissue with a deployed force that is greater than an applied force by a user, the actuator is configured to translate rotational motion into linear motion, if the user is weaker than the motor.
Olien et al, from a related field of endeavor teaches a similar system as shown in Figure 3, where configuring an actuator to deployed force that is greater than an applied force by a user (using the same technique of using a motor as taught by Rosenthal) is known for the purpose in assisting a user apply a force or reducing the amount of force a user needs to apply. See paragraph [0041].
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 system disclosed by Rosenthal to include the motor taught by Yap et al. such that the actuator was capable of advancing the anchor delivery element into tissue with a deployed force that is greater than an applied force by a user for the purpose of assisting a user apply a force or reducing the amount of force a user needs to apply (as suggested by Olien).
Abbate et al., from the same field of endeavor teaches a similar system as shown in Figure 5A, where the delivery device further comprises, a cannula having a curved distal end and an atraumatic tip. See paragraphs [0020], [0153].
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Rosenthal to include the cannula having a curved distal end and an atraumatic tip in order to deliver a part of the system atraumatically within the body.
Regarding claim 36, Rosenthal discloses wherein the elongate tension element comprises a biodegradable polymer. See paragraph [0026].
Regarding claim 37, Rosenthal discloses wherein the biodegradable polymer comprises PDO (Poly(dioxanone)). See paragraph [0102].
Regarding claims 48-52, 55, 61 Rosenthal et al. discloses as shown Figures 3A, 3B, 4A a method for shaping one or more tissues comprising: advancing an anchor delivery element with a distal anchor of an elongate tension element (implant 32, see paragraphs [0061], [0065]), wherein the distal anchor comprises one or more arms (arm 76a, 76b); advancing the anchor delivery element with the distal anchor coupled thereto through the one or more tissues; tensioning the elongate tension element to a tensioned state; and securing the elongate tension element to the one or more tissues in its tensioned state, wherein the anchor delivery element is coupled to the distal anchor via the one or more arms, wherein a distal end of the one or more arms is beveled, wherein the distal anchor further comprises a pivot point, an insertion configuration, and a deployed configuration, wherein the anchor delivery element is coupled to the distal anchor via the one or more arms, wherein a distal end of the one or more arms is beveled, wherein the distal anchor further comprises a pivot point, an insertion configuration, and a deployed configuration, wherein tensioning the elongate tension element comprises applying a force to the elongate tension element to swivel the distal anchor at the pivot point from the insertion configuration to the deployed configuration, a plurality of proximal anchors (ridges, see paragraph [0016]) between the distal anchor and the proximal end, wherein tensioning the elongate tension element is used to treat nasal airway obstruction (See paragraph [0064]).
Rosenthal et al. fails to disclose advancing a cannula through the one or more tissues, wherein the cannula comprises a curved distal end and a sharp tip, coupled thereto through the distal end of the cannula.
Rosenthal et al. fails to disclose the actuator is capable of advancing the anchor delivery the anchor delivery element with the distal anchor coupled thereto through the distal end of the cannula and through the one or more tissues, a cannula comprising a curved distal end and a sharp tip.
To be clear, the Office interprets needle 312 coupling implant 32 to actuator 306, because the implant 32 is disposed within needle 312, which is directly coupled handle 302, which is movably coupled to actuator 306. Thus, needle 312 indirectly couples implant 32 to actuator 306, via the handle.
Rosenthal et al. fails to disclose the actuator is capable of advancing the anchor delivery element into tissue with a deployed force that is greater than an applied force by a user.
Yap et al., from a related field of endeavor teaches a similar system as show in Figure 1, where the actuator (motor, plunger, see paragraph [0085]) is capable of advancing a delivery element into tissue with a deployed force that is greater than an applied force by a user, the actuator is configured to translate rotational motion into linear motion, if the user is weaker than the motor.
Olien et al, from a related field of endeavor teaches a similar system as shown in Figure 3, where configuring an actuator to deployed force that is greater than an applied force by a user (using the same technique of using a motor as taught by Rosenthal) is known for the purpose in assisting a user apply a force or reducing the amount of force a user needs to apply. See paragraph [0041].
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 system disclosed by Rosenthal to include the motor taught by Yap et al. such that the actuator was capable of advancing the anchor delivery element into tissue with a deployed force that is greater than an applied force by a user for the purpose of assisting a user apply a force or reducing the amount of force a user needs to apply (as suggested by Olien).
Abbate et al., from the same field of endeavor teaches a similar system as shown in Figure 5A, where the delivery device further comprises, a cannula having a curved distal end and an atraumatic tip. See paragraphs [0020], [0153].
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Rosenthal to include the cannula having a curved distal end and an atraumatic tip in order to deliver a part of the system atraumatically within the body.
Regarding claim 53, Rosenthal discloses the elongate tension element is used to treat nasal septal deviation. See paragraph [0064] disclosing the implant is put near the septum which would necessarily treat nasal septal deviation.
Regarding claim 57, Rosenthal fails to disclose wherein the tension element in its tensioned state applies a force ranging from about 4.0 Newtons to about 10 Newtons to the one or more nasal tissues.
However, Rosenthal recognizes the force applied is a result effective variable for the purpose of supporting tissue in need of alteration and support. See paragraph [0063].
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 system disclosed by Rosenthal in view of Yap such that wherein the tension element in its tensioned state applies a force ranging from about 4.0 Newtons to about 10 Newtons to the one or more nasal tissues because it would only require discovering an optimum value of a result effective variable which has been held to involve only routine skill in the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 58, Rosenthal discloses wherein the elongate tension element comprises a biodegradable polymer. See paragraph [0026].
Regarding claim 59, Rosenthal discloses wherein the biodegradable polymer comprises PDO (Poly(dioxanone)). See paragraph [0102].
Claim(s) 38 and 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0058556 (Rosenthal et al.) in view of U.S. Patent Publication Number 2002/0077598 (Yap et al.) and U.S. Patent Publication Number 2011/0118779 (Olien et al.), U.S. Patent Publication Number 2014/0074238 (Abbate et al.) as applied to claims 31 and 58 above, and further in view of U.S. Patent Publication Number 2003/0060846 (Egnelov et al.)
Regarding claims 38 and 60, Rosenthal et al. fails to disclose wherein the biodegradable polymer is configured to biodegrade over a period of at least about six months.
Egnelov et al., from a related field of endeavor teaches a similar system as shown in Figure 1 with a similar biodegradable polymer used for a similar purpose wherein the biodegradable polymer is configured to biodegrade over a period of at least about six months. See paragraph [0031].
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 system disclosed by Rosenthal et al. by substituting the biodegradable polymer disclosed by Rosenthal in view of Yap, Olien and Abbate for the one taught by Egnelov et al. because it would only require the simple substitution of one know alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0058556 (Rosenthal et al.) in view of U.S. Patent Publication Number 2002/0077598 (Yap et al.) and U.S. Patent Publication Number 2011/0118779 (Olien et al.), U.S. Patent Publication Number 2014/0074238 (Abbate et al.) as applied to claim 31 above, and further in view of U.S. Patent Publication Number 2011/0093004 (Ierulli et al.)
Regarding claim 39, Rosenthal fails to disclose wherein the elongate tension element has a tensile strength ranging from about 100 MPa to about 800 MPa.
Ierulli et al., from the same field of endeavor teaches a similar tension device as shown in Figure 15, where the tensile strength is a recognized result effective variable for the purpose of preventing inadvertent longitudinal stretching of the tension element. See paragraph [0152].
It would have been obvious to one for ordinary skill in the art, before the effective filing date of the claimed invention to modify the delivery device taught by Rosenthal such that the elongate tension element has a tensile strength ranging from about 100 MPa to about 800 MPa because it would only require discovering an optimum value of a result effective variable which has been held to involve only routine skill in the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 40, 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0058556 (Rosenthal et al.) in view of U.S. Patent Publication Number 2002/0077598 (Yap et al.) and U.S. Patent Publication Number 2011/0118779 (Olien et al.), U.S. Patent Publication Number 2014/0074238 (Abbate et al.) as applied to claim 31 above, and further in view of U.S. Patent Publication Number 2001/0054428 (Knudson et al.)
Regarding claims 40, 41 Rosenthal et al. fails to disclose wherein the elongate tension element has a rectangular cross-sectional shape.
Knudson, from the same field of endeavor teaches a similar elongate tension element wherein the elongate tension element has a rectangular cross-sectional shape, wherein the cannula has a non-circular cross-sectional shape. See paragraph [0102.
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 elongate tension element disclosed by Rosenthal et al. by substituting its shape for the rectangular cross-sectional shape taught by Knudson because it would only require the simple substitution of one known alternative to for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 42, 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0058556 (Rosenthal et al.) in view of U.S. Patent Publication Number 2002/0077598 (Yap et al.) and U.S. Patent Publication Number 2011/0118779 (Olien et al.), U.S. Patent Publication Number 2014/0074238 (Abbate et al.) as applied to claim 31 above, and further in view of U.S. Patent Publication Number 2013/0331839 (Hester et al.)
Regarding claim 42, Rosenthal in view of Yap, Olien and Abbate fail to disclose a handle coupled to a proximal end of the cannula.
Rosenthal fails to disclose wherein the delivery device further comprises a handle and a knob attached to a proximal end of the cannula, and wherein the knob is configured to rotate the cannula about a longitudinal axis of the handle.
Hester et al., from the same field of endeavor teaches a similar delivery device as shown in Figure 6, where wherein the delivery device further comprises a handle (handle 32) and a knob (rotatable knob) attached to a proximal end of the cannula, and wherein the knob is configured to rotate the cannula about a longitudinal axis of the handle. See paragraph [0054].
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 system disclosed by Rosenthal in view of Yap, Olien and Abbate to include the knob taught by Hester, in order to configure the cannula to be rotated about its longitudinal axis.
Regarding claim 43, Rosenthal in view of Yap, Olien and Abbate discloses wherein the actuator comprises a tab (flange indicated at 306 in Figure 4B) configured to move back and forth with respect to the handle.
Claim(s) 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0058556 (Rosenthal et al.) in view of U.S. Patent Publication Number 2002/0077598 (Yap et al.) and U.S. Patent Publication Number 2011/0118779 (Olien et al.), U.S. Patent Publication Number 2014/0074238 (Abbate et al.) as applied to claim 48 above, and further in view of U.S. Patent Publication Number 2013/0158525 (Blitzer et al.)
Regarding claim 54, Rorsenthal et al. fail to disclose wherein tensioning the elongate tension element is used to manipulate a nasal turbinate.
Blitzer et al., from the same field of endeavor teaches a similar method that includes the step of manipulating the nasal turbinate for the purpose of treating it. See paragraph [0046].
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 method disclosed by Rorsenthal et al. such that the step of tensioning the elongate tension element is used to manipulate a nasal turbinate as taught by Blitzer et al. in order to treat the nasal turbinate.
Claim(s) 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0058556 (Rosenthal et al.) in view of U.S. Patent Publication Number 2002/0077598 (Yap et al.) and U.S. Patent Publication Number 2011/0118779 (Olien et al.), U.S. Patent Publication Number 2014/0074238 (Abbate et al.) as applied to claim 48 above, and further in view of U.S. Patent Publication Number 2007/0144539 (van de Burg et al.)
Regarding claim 56, Rosenthal et al. fails to disclose wherein tensioning the elongate tension element is used to manipulate a throat tissue or a soft palate.
van de Burg et al., from the same field of endeavor teaches a similar method that includes the step of manipulate a throat tissue or a soft palate for the purpose of treating that area. See paragraph [0029].
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 method disclosed by Rorsenthal et al. such that the step of tensioning the elongate tension element is used to manipulate a throat tissue or a soft palate as taught by van de Burg et al. in order to treat a soft palate.
Claim(s) 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0058556 (Rosenthal et al.) in view of U.S. Patent Publication Number 2002/0077598 (Yap et al.) and U.S. Patent Publication Number 2011/0118779 (Olien et al.), U.S. Patent Publication Number 2014/0074238 (Abbate et al.) as applied to claim 48 above, and further in view of U.S. Patent Publication Number 2011/0029071 (Zlotnick et al.)
Regarding claim 62, Rosenthal et al. fails to disclose detaching a needle at a proximal end of the elongate tension element.
Zlotnick et al., from the same field of endeavor teaches a similar method as shown in Figure 1, which includes the step of detaching a needle at a proximal end of the elongate tension element, for the purpose of removing the needle after it is no longer needed.
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 method disclosed by Rosenthal et al. to detaching a needle at a proximal end of the elongate tension element in order to remove the needle after it is no longer needed.
Conclusion
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771
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