DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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 .
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 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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 130, 365(c) & 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 15/103500, PCT/US2014/069971 & 61/915282 all provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Accordingly, the claims are given the priority benefit date of 12/12/2013.
Specification
The disclosure is objected to because of the following informalities: amen the specification to include the appropriate patent number for 15/103500 in the first paragraph.
Appropriate correction is required.
The amendment filed 5/23/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The incorporation by reference of the international patent application PCT/US2014/069971 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 12/12/2014, see MPEP 1893.03(b). Therefore, the specification amendment of 5/23/2025* to include the incorporation by reference is new matter, per MPEP 608.01(p).
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim 39 is objected to because of the following informalities: amend “wherein first” to -wherein the first- in ll. 1. Appropriate correction is required.
Claim 51 is objected to because of the following informalities: amend “and a circumferential” to -or a circumferential- in ll. 10. Appropriate correction is required.
Claim 53 is objected to because of the following informalities: amend “a catheter assembly to a user” to -the catheter assembly to the user- in ll. 1. Appropriate correction is required.
Claim 53 is objected to because of the following informalities: amend “a handle assembly” to -the handle assembly- in ll. 3. 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 51-53 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 51 recites the limitations of “A method” and “providing a catheter assembly” and “providing instructions to the user”. Since there are no method steps other than the “providing” steps, it is unclear what method is actually being claimed as the claim.
Claims 52-53 depend from claim 41 and also only claim “providing” steps and are thus also rejected in the same manner.
Claim Interpretation
The Examiner notes the claims recite “handle assembly” and “ablation assembly”, both of which provide sufficient specificity and thus do not invoke 35 USC 112(f).
Claim 51 recites printed matter instructions. See MPEP 2111.05, and in particular 11. Regarding printed matter instructions. In the instant case, the instructions (printed matter) are not functionally related to the structure of the method, the claimed invention does not patentably distinguish from the prior art reference(s). In order for the printed matter (instructions) to impart patentability to the method, there must be a new and non-obvious functional relationship between the printed matter and some element of the kit (i.e. substrate).
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: “coupling assembly” in claim 52.
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 § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 35-41 & 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mayse et al. (2011/0152855) in view of Suda (2008/0242925) and Avellanet (6,352,539).
Concerning claim 35, as illustrated in at least Figs. 2-3 & 8, Mayse et al. disclose a method of pulmonary treatment (method of damaging nerve tissue in airways; [0019]) comprising:
introducing a catheter into an airway of a patient through a delivery device (a delivery device in the form of a catheter system 204 extending through a delivery apparatus 206 is introduced such that ablation assembly 208 is located in a bronchus; [0159], [0197-0198]);
moving the handle assembly to maneuver a distal portion of the catheter circumferentially to a first circumferential position within the airway; administering a first treatment at said first circumferential position; maneuvering the handle assembly to maneuver the distal portion of the catheter circumferentially to a second circumferential position within the airway; and administering a second treatment at said second circumferential position; (a circumferential lesion can be formed around all or most of the circumference of the airway wall 100 by ablating tissue while slowly rotating the ablation assembly 208 or by positioning the ablation assembly 208 in a series of rotational positions at each of which energy is delivered for a desired time period and the catheter 207 may be repositioned to treat other locations or removed from the subject entirely, where an element of the handle assembly or the handle assembly itself is inherent to maneuver the catheter; [0212]).
While Mayse et al. disclose the use of the catheter assembly (204) with the delivery apparatus (206) that can be an endoscope ([0197]), Mayse et al. fail to disclose specifics of the delivery device and the handle assembly, and a specifically securing the handle assembly coupled to the catheter to the delivery device, moving a control on the handle assembly maneuvers the distal portion of the catheter to the first and second positions while the handle assembly remains secured to the delivery device. However, Suda discloses a catheter and handle assembly (20: 21, 22) coupled to an endoscope delivery device (1), wherein the handle assembly (22) coupled to the catheter (21) is first secured to the delivery device (1) and then a control (29) on the handle assembly (22) is moved to maneuver a distal portion (27) of the catheter (21) to first and second positions with respect to the delivery device (1) while the handle assembly (22) remains secured to the delivery device (1). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Mayse et al. to further comprise securing the handle assembly coupled to the catheter to the delivery device, moving a control on the handle assembly maneuvers the distal portion of the catheter to the first and second positions while the handle assembly remains secured to the delivery device in order to provide the benefit of fixing an operation section of the delivery device to the distal portion of the catheter such that accurate operation of axial movement of the distal assembly can be performed as taught by Suda. ([0015-0016], [0024], [0037-0040], [0054-0056], [0077]; Fig. 1-4).
Mayse et al. in view of Suda fail to disclose moving the control maneuvers the distal portion of the catheter circumferentially to the first and second circumferential positions while the handle assembly remains secured to the delivery device. However, Avellanet discloses a catheter and handle assembly (10) coupled to a delivery device (endoscope), the catheter assembly including a distal portion (24) and a handle assembly (26), the handle assembly (26) comprising a control (40, 42) configured to rotate the distal portion (24) with respect to the delivery device (endoscope) between first and second circumferential positions. At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Mayse et al. in view of Suda to further comprise moving the control maneuvers the distal portion of the catheter circumferentially to the first and second circumferential positions while the handle assembly remains secured to the delivery device in order to provide the benefit of orienting the distal assembly to facilitate treatment as taught by Avellanet. (Col. 1, II. 48-58, Col. 2, II. 28-60, Col. 4, II. 23-36, Col. 4-5, II. 63-40; Fig. 1-2)
Concerning claim 36, Mayse et al. further discloses the delivery device (206) remains in a stationary position relative to tissue as the distal portion (208) of the catheter (204) is maneuvered to the first and second circumferential positions ([0319]; Fig. 119).
Concerning claim 37, Mayse et al. disclose moving the control (inherent) to retract the distal portion (208) of the catheter (204) into the delivery device (206) after the first treatment and before the second treatment ([0212]). Suda further discloses moving the control (29) while the handle assembly (22) remains secured to the delivery device (1) to retract the distal portion (27) of the catheter (21) into the delivery device (1) ([0016]; Fig. 3).
Concerning claim 38, Mayse et al. disclose the distal portion (208) of the catheter (204) comprises an expandable member (212), wherein the control is moved such that an entire length of the expandable member is retracted within the delivery device (206) ([0158-0159]; Fig. 2-3).
Concerning claim 39, Mayse et al. disclose the first and second treatments comprise delivering energy from the distal portion of the catheter (204) to a wall of the airway to ablate a nerve trunk along the wall ([0212]).
Concerning claim 40, Mayse et al. disclose the delivery device (2410) comprises an optical channel (2440), the method further comprising viewing the distal portion (2450) of the catheter (2400) through the optical channel ([2440]) as it is maneuvered to the first and second circumferential positions ([0197], [0303-0305]; Fig. 101).
Concerning claim 41, Mayse et al. disclose the distal portion (2450) of the catheter (2400) has an expandable member (2460) coupled thereto, further comprising moving the control to a predetermined position in which the expandable member (2460) is optically coupled with the optical channel (2440) when expanded ([0197], [0303-0305]; Fig. 101).
Concerning claim 50, as illustrated in at least Figs. 2-3, 8 & 100, Mayse et al. disclose a method of pulmonary treatment (method of damaging nerve tissue in airways; [0019]) comprising:
introducing a catheter into an airway of a patient through a delivery device (a delivery device in the form of a catheter system 204 extending through a delivery apparatus 206 is introduced such that ablation assembly 208 is located in a bronchus; [0159], [0197-0198]);
moving the handle assembly to maneuver a distal portion of the catheter axially and circumferentially within the airway into a position to administer pulmonary treatment to a patient (ablation assembly 208 can be axially extended beyond delivery device 206 such that a circumferential lesion can be formed around all or most of the circumference of the airway wall 100 by ablating tissue while slowly rotating the ablation assembly 208 or by positioning the ablation assembly 208 in a series of rotational positions at each of which energy is delivered for a desired time period and the catheter 207 may be repositioned to treat other locations or removed from the subject entirely, where an element of the handle assembly or the handle assembly itself is inherent to maneuver the catheter; [0159], [0212]), wherein the distal portion of the catheter is maneuverable independently of a visualization device coupled to the delivery device (catheter 2400 is maneuverable through working lumen 2430 independent of optical element 2440; [0303-0304]; Fig. 101-104).
While Mayse et al. disclose the use of the catheter assembly (204) with the delivery apparatus (206) that can be an endoscope ([0197]), Mayse et al. fail to disclose specifics of the delivery device and the handle assembly, and a specifically securing the handle assembly coupled to the catheter to the delivery device, moving a control on the handle assembly maneuvers the distal portion of the catheter axially to the first and second positions. However, Suda discloses a catheter and handle assembly (20: 21, 22) coupled to an endoscope delivery device (1), wherein the handle assembly (22) coupled to the catheter (21) is first secured to the delivery device (1) and then a control (29) on the handle assembly (22) is moved to axially maneuver a distal portion (27) of the catheter (21) to first and second positions with respect to the delivery device (1) while the handle assembly (22) remains secured to the delivery device (1). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Mayse et al. to further comprise securing the handle assembly coupled to the catheter to the delivery device, moving a control on the handle assembly maneuvers the distal portion of the catheter axially to the first and second positions in order to provide the benefit of fixing an operation section of the delivery device to the distal portion of the catheter such that accurate operation of axial movement of the distal assembly can be performed as taught by Suda. ([0015-0016], [0024], [0037-0040], [0054-0056], [0077]; Fig. 1-4).
Mayse et al. in view of Suda fail to disclose moving the control maneuvers the distal portion of the catheter circumferentially to the first and second circumferential positions. However, Avellanet discloses a catheter and handle assembly (10) coupled to a delivery device (endoscope), the catheter assembly including a distal portion (24) and a handle assembly (26), the handle assembly (26) comprising a control (40, 42) configured to rotate the distal portion (24) with respect to the delivery device (endoscope) between first and second circumferential positions. At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Mayse et al. in view of Suda to further comprise moving the control maneuvers the distal portion of the catheter circumferentially to the first and second circumferential positions in order to provide the benefit of orienting the distal assembly to facilitate treatment as taught by Avellanet. (Col. 1, II. 48-58, Col. 2, II. 28-60, Col. 4, II. 23-36, Col. 4-5, II. 63-40; Fig. 1-2)
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mayse et al. (2011/0152855) in view of Suda (2008/0242925) and Avellanet (6,352,539), as applied to claim 35, in further view of Band et al. (2007/0293857).
Concerning claim 42, while Mayse et al. disclose visualizing an indicator (2310a) on the distal portion of the catheter (2300) while maneuvering the distal portion to the first and second circumferential positions ([0300-0302]; Fig. 98-100). Mayse et al. fail to disclose fluoroscopically visualizing the indicator. However, Band et al. disclose a catheter and handle assembly (10) comprising a catheter assembly (12) including an elongate shaft (15) and a treatment assembly (20), wherein a first end (21) of the elongate shaft (15) includes a fluoroscopically visible indicator device (70) and that is fluoroscopically visualizes to indicate alignment of an ablation treatment assembly (20). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Mayse et al. in view of Suda and Avellanet such that the first end of the elongate shaft includes a fluoroscopically visible indicator device, wherein the indicator device indicates alignment of the ablation assembly relative to the delivery device in order to provide the benefit of indication position of the treatment assembly with respect to the catheter using fluoroscopy as taught by Band et al. ([0030-0031]; Fig. 2).
Claim(s) 51-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mayse et al. (2011/0152855) in view of Suda (2008/0242925), Avellanet (6,352,539), and Heim et al. (2007/0005059).
Concerning claims 51 & 53, as illustrated in at least Figs. 2-3, 8 & 100, Mayse et al. disclose a method (method of damaging nerve tissue in airways; [0019]) comprising:
providing a catheter assembly to a user (catheter system 204 is inherently manufactured and made available; [0159]), the catheter including:
an elongate shaft (shaft 230; [0181]); and
an ablation assembly coupled to a first end of the elongate shaft, the ablation assembly having an energy emitter thereon (ablation assembly 208 having an ablation element such as an RF electrode 214; [0159], [0166]);
providing a handle assembly to the user (proximal end of catheter assembly 204 as seen in Fig. 1-2 is inherently manufactured and made available), the handle assembly coupled to a second end of the elongate shaft (shaft 207 couples to a proximal end handle), the handle assembly moving the ablation assembly in at least one of an axial and a circumferential direction relative to the handle frame (ablation assembly 208 can be extended and retracted from delivery device 206 a circumferential lesion can be formed around all or most of the circumference of the airway wall 100 by ablating tissue while slowly rotating the ablation assembly 208 or by positioning the ablation assembly 208 in a series of rotational positions at each of which energy is delivered for a desired time period and the catheter 207 may be repositioned to treat other locations or removed from the subject entirely, where an element of the handle assembly or the handle assembly itself is inherent to maneuver the catheter; [0159], [0212]).
While Mayse et al. disclose operating the handle assembly so as to move the ablation assembly axially and circumferentially into a desired position in an airway of a patient; and administering pulmonary treatment to the patient via the ablation assembly (ablation assembly 208 can be axially extended beyond delivery device 206 such that a circumferential lesion can be formed around all or most of the circumference of the airway wall 100 by ablating tissue while slowly rotating the ablation assembly 208 or by positioning the ablation assembly 208 in a series of rotational positions at each of which energy is delivered for a desired time period and the catheter 207 may be repositioned to treat other locations or removed from the subject entirely, where an element of the handle assembly or the handle assembly itself is inherent to maneuver the catheter; [0159], [0212), Mayse et al. fail to disclose the handle assembly securely coupleable to an end of the elongate shaft and a port of a delivery device, the handle assembly comprising a handle frame and a control, movable relative to the handle frame and coupled to the elongate shaft such that moving the control moves the ablation assembly in at least one of the axial and the circumferential direction relative to the handle frame to move the ablation assembly axially into a desired position in an airway of a patient to administer treatment via the ablation assembly. However, Suda discloses a catheter and handle assembly (20: 21, 22) coupled to an endoscope delivery device (1), wherein the handle assembly (22) coupled to the catheter (21) is first secured to the delivery device (1) and then a control (29) on the handle assembly (22) is moved to axially to maneuver a distal portion (27) of the catheter (21) to first and second positions with respect to the delivery device (1) while the handle assembly (22) remains secured to the delivery device (1). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Mayse et al. such that the handle assembly is securely coupleable to an end of the elongate shaft and a port of a delivery device, the handle assembly comprising a handle frame and a control, movable relative to the handle frame and coupled to the elongate shaft such that moving the control moves the ablation assembly in at least one of the axial and the circumferential direction relative to the handle frame to move the ablation assembly axially into a desired position in an airway of a patient to administer treatment via the ablation assembly in order to provide the benefit of fixing an operation section of the delivery device to the distal portion of the catheter such that accurate operation of axial movement of the distal assembly can be performed as taught by Suda. ([0015-0016], [0024], [0037-0040], [0054-0056], [0077]; Fig. 1-4).
Mayse et al. in view of Suda fail to disclose operating the control movable relative to the handle frame such that moving the control moves the ablation assembly in a circumferential direction relative to the handle frame to move the ablation assembly axially into a desired position in an airway of a patient to administer treatment via the ablation assembly. However, Avellanet discloses a catheter and handle assembly (10) coupled to a delivery device (endoscope), the catheter assembly including a distal portion (24) and a handle assembly (26), the handle assembly (26) comprising a control (42) and a frame (40), the control (42) configured to move relative to the frame (40) and rotate the distal portion (24) with respect to the delivery device (endoscope) between first and second circumferential positions. At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Mayse et al. in view of Suda such that operating the control movable relative to the handle frame such that moving the control moves the ablation assembly in a circumferential direction relative to the handle frame to move the ablation assembly axially into a desired position in an airway of a patient to administer treatment via the ablation assembly in order to provide the benefit of orienting the distal assembly to facilitate treatment as taught by Avellanet. (Col. 1, II. 48-58, Col. 2, II. 28-60, Col. 4, II. 23-36, Col. 4-5, II. 63-40; Fig. 1-2)
Mayse et al. in view of Suda and Avellanet fail to disclose instructions comprising securing the handle assembly to a port of a delivery device, operating the control to administer pulmonary treatment via the ablation assembly. However, Heim et al. disclose a kit comprising printed instructions for assembly and use of a device. At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Mayse et la. in view of Suda and Avellanet to further comprise instructions comprising securing the handle assembly to a port of a delivery device, operating the control to administer pulmonary treatment via the ablation assembly in order to provide the benefit of informing the user how to assemble and use the device as taught by Heim et al. ([0123]; Claim 45).
Concerning claim 52, Suda further discloses providing a coupling assembly (24) to the user, the coupling assembly configure to couple the handle assembly (22) and the port (5a) of the delivery device (1), the coupling assembly (24) configured to remain fixed relative to the delivery device (1) while the ablation assembly (27) is moved ([0088-0104], [0114]; Fig. 4).
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 35 & 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24 of U.S. Patent No. 12,114,916. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a method comprising: introducing a catheter into an airway of a patient through a delivery device (the assembly further comprises the delivery device, wherein the delivery device to which the catheter and handle assembly is configured to be coupled comprises a bronchoscope); securing a handle assembly coupled to the catheter to the delivery device (when the catheter and handle assembly is coupled to the delivery device); moving a control on the handle assembly (the control being movable relative to and over the handle frame and coupled to the elongate shaft) to maneuver a distal portion of the catheter circumferentially to a first circumferential position within the airway (wherein the body is configured to rotate about the handle frame via the bearing when the catheter and handle assembly is coupled to the delivery device to rotate the ablation assembly with respect to the delivery device when the expandable member is in the second expanded state); moving the control on the handle assembly to maneuver the distal portion of the catheter circumferentially to a second circumferential position within the airway; wherein the handle assembly remains secured to the delivery device while maneuvering the distal portion of the catheter to the first and second circumferential positions (control being movable relative to and over the handle frame and coupled to the elongate shaft, wherein the control comprises a body positioned over the handle frame and a bearing frictionally affixed to an interior surface of the body, wherein the second end of the elongate shaft is coupled to the body, and wherein the body is configured to rotate about the handle frame via the bearing when the catheter and handle assembly is coupled to the delivery device to rotate the ablation assembly with respect to the delivery device when the expandable member is in the second expanded state). While the patent teaches using a bronchoscope (claim 21), the patent fails to specifical disclose a method of pulmonary treatment comprising introducing the catheter into an airway and administering first and second treatments at the first and second position. However, Mayse et al. teach a method of pulmonary treatment comprising introducing a catheter into an airway and administering first and second treatments at first and second positions. At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of to comprise a method of pulmonary treatment comprising introducing a catheter into an airway and administering first and second treatments at first and second positions in order to provide the benefit of treatment of pulmonary diseases as taught by Mayse et al. ([0015], [0212]).
Claims 51-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24 of U.S. Patent No. 12,114,916. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a method (treatment to the subject, claim 24), comprising: providing a catheter assembly to a user (a catheter) , the catheter including: an elongate shaft (an elongate shaft); and an ablation assembly coupled to a first end of the elongate shaft, the ablation assembly having an energy emitter thereon (an ablation assembly coupled to a first end of the elongate shaft, the ablation assembly comprises an expandable member having an energy emitter thereon, the expandable member being movable between a first retracted state and a second expanded state); providing a handle assembly to the user, the handle assembly coupleable to a second end of the elongate shaft, the handle assembly including: a handle frame; and a control, movable relative to the handle frame and coupled to the elongate shaft such that moving the control moves the ablation assembly in at least one of an axial and a circumferential direction relative to the handle frame (a handle fixed to a second end of the elongate shaft, the handle including a first portion, and a second portion axially and rotationally movable over the first portion via a bearing frictionally affixed to an interior surface of the second portion to axially and rotationally manipulate the expandable member); and providing instructions to the user, the instructions comprising: securing the handle assembly to a port of a delivery device; operating the control on the handle assembly so as to move the ablation assembly axially and circumferentially into a desired position in an airway of a patient; and administering pulmonary treatment to the patient via the ablation assembly (a set of instructions configured for use with the catheter and handle assembly, the set of instructions comprising a recitation of steps including: positioning the ablation assembly in a lumen of a subject by moving the ablation assembly through the working channel of the delivery device; coupling the first portion of the handle to the delivery device; and moving the second portion of the handle while the first portion remains fixed to the delivery device so as to move the ablation assembly axially and circumferentially into a position in the lumen to administer a treatment to the subject).
Allowable Subject Matter
Claim 43 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art, neither alone nor in combination, teaches “manipulating the delivery device with the handle assembly secured thereto to rotationally reposition the distal portion of the catheter relative to the airway after administering the first treatment and before administering the second treatment”. As discussed in the specification, rotational and axial translation of the scope with the handle assembly secured thereto to allows for coarse adjustment of the ablation assembly within the airway. While Suda teaches capability of the scope to rotationally reposition the distal portion of the catheter by rotating the scope in space, Suda fails to teach a method doing so after administering the first treatment and before administering the second treatment as required by claim 43.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Truckai et al. (2004/0054368) teach printed matter instructions for use of a device ([0029]).
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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