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 .
Response to Amendment
In response to the amendment filed on 11/13/2025, No Claims have been cancelled, and Claims 1-19 are pending.
Election/Restrictions
Applicant’s election WITHOUT traverse of GROUP I in the reply filed on 11/13/2025 is acknowledged. Claim 20 has been withdrawn from further consideration and claims 1-19 are pending.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6: the limitation “resiliently based” in Line 2 appears to be a typographical error and this limitation should read “resiliently biased”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Locking features in claims 7, 8, and 11.
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
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) 1, 3-5, 13-15, 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Drontle (US PGPub 2010/0312101) in view of Palushi (US PGPub 2020/0197670).
Regarding Claim 1, Drontle teaches an apparatus (Figures 3A-3B), comprising:
a body assembly (12; Figure 3A; Paragraph 0025);
a guide rail (40) extending distally from the body assembly (12) (Figure 3A-3B; Paragraph 0028),
a dilation catheter (30) slidably disposed relative to the guide rail (40) (, the dilation catheter (30) including:
an expandable element (36) configured to dilate a passageway within a head of a patient (Paragraph 0027), and
a distal end (34); and
a guide rail actuation assembly (32/42; Figure 2A, 3A; Paragraph 0027) operable to drive longitudinal movement of the guide rail (40) relative to the body assembly (12) between a distal position (Figure 3A) and a proximal position (Figure 2A), the guide rail actuation assembly (32/42) being configured to maintain the guide rail at a selected one of the distal position or the proximal position (Paragraph 0031).
Drontle fails to disclose:
the guide rail having a malleable distal portion with a distal end.
Palushi teaches a sinuplasty instrument with a deflectable guide rail (abstract), wherein the guide rail (830) is translatable relative to the body (500; see relative movement between Figures 5A-5B), wherein the guide rail has a malleable distal portion (832) with a distal end (840) (Paragraph 0053-0054), for the purpose of deflecting an inner guide member (840) (as shown in figures 5A-5D) of which the balloon dilator (702) is slid upon.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the guide rail taught by Drontle, with the malleable guide rail teachings of Palushi, for the advantage of manipulating the inner guide member (14) of Drontle, such that the curved distal portion (16) of the inner guide member (14) of Drontle can be manipulated from outside the patient while in use (see Paragraph 0041 and Figures 6A-6C of Drontle and Paragraph 0054 of Palushi).
Regarding Claim 3, the combination of references disclosed above teaches the apparatus of claim 1, wherein Drontle teaches at least a portion of the guide rail actuation assembly (32) being positioned proximally relative to the body assembly (12; as seen in Figure 1 and 2A, the actuator knob is positioned proximally relative to the distal end (26) of the body assembly).
Regarding Claim 4, the combination of references disclosed above teaches the apparatus of claim 1, at least a portion of the guide rail actuation assembly (32) being positioned distally relative to the body assembly (12; as seen in Figure 1 and 2A, the actuator knob is positioned distally relative to the proximal end (24) of the body assembly).
Regarding Claim 5, the combination of references disclosed above teaches the apparatus of claim 1, wherein Drontle teaches the guide rail actuation assembly (32) being translatable relative to the body assembly (12) between a distal position (Figure 3A-3B) and a proximal position (Figure 2A-2B; Drontle).
Regarding Claim 13, the combination of reference disclosed above teaches the apparatus of claim 1, wherein Drontle teaches the guide rail actuation assembly (32) comprising a knob (see Figure 2B).
Regarding Claim 14, the combination of references disclosed above teaches the apparatus of claim 1, wherein Drontle teaches the guide rail actuation assembly (32) comprising a rod (see pin connecting 32 to guide 40 in Figure 2B).
Regarding Claim 15, the combination of references disclosed above teaches the apparatus of claim 1, wherein Drontle teaches the guide rail actuation assembly (32) comprising a slider (32; Figure 2A, 2B).
a guide rail actuation assembly, the guide rail actuation assembly being coupled with the body assembly and movable relative to the body assembly, the guide rail actuation assembly being operable to drive longitudinal movement of the guide rail relative to the body assembly between a distal position and a proximal position, the guide rail actuation assembly being configured to maintain the guide rail at a selected one of the distal position or the proximal position.
Regarding Claim 17, the combination of references disclosed above teaches the apparatus of claim 1, but Drontle fails to disclose further comprising a dilation catheter actuation assembly, the dilation catheter actuation assembly being operable to drive longitudinal movement of the dilation catheter along the guide rail.
Palushi teaches an guide rail actuation assembly (820/810) for actuating the guide rail (830; see Figures 5A-5C) relative to the body (500) and further comprising a dilation catheter actuation assembly (700), the dilation catheter actuation assembly (700) being operable to drive longitudinal movement of the dilation catheter (702) along the guide rail (830).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Drontle to have two distinct actuation mechanisms, as taught by Palushi, for the advantage of providing independent movement between the guide rail and the dilation catheter.
Regarding Claim 19, Drontle teaches an apparatus (Figures 3A-3B), comprising:
a body assembly (12; Figure 3A; Paragraph 0025);
a guide rail (40) with a distal end (distal tip of element 40; Figure 3A-3B; Paragraph 0028),
a dilation catheter (30) slidably disposed relative to the guide rail (40) (, the dilation catheter (30) including:
an expandable element (36) configured to dilate a passageway within a head of a patient (Paragraph 0027), and
a distal end (34); and
a guide rail actuation assembly (32/42; Figure 2A, 3A; Paragraph 0027), the guide rail actuation assembly being coupled with the body assembly (12; Figure 2B, 3B) and movable relative to the body assembly (12; as seen in Figures 2A-3B), the guide rail actuation assembly (32) being operable to drive longitudinal movement of the guide rail (40) relative to the body assembly (12) between a distal position (Figure 3A) and a proximal position (Figure 2A; Paragraph 0027); the guide rail actuation assembly (32) being configured to maintain the guide rail (40) at a selected one of the distal position or the proximal position (Paragraph 0031).
Drontle fails to disclose:
the guide rail having a malleable distal portion with a distal end.
Palushi teaches a sinuplasty instrument with a deflectable guide rail (abstract), wherein the guide rail (830) is translatable relative to the body (500; see relative movement between Figures 5A-5B), wherein the guide rail has a malleable distal portion (832) with a distal end (840) (Paragraph 0053-0054), for the purpose of deflecting an inner guide member (840) (as shown in figures 5A-5D) of which the balloon dilator (702) is slid upon.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the guide rail taught by Drontle, with the malleable guide rail teachings of Palushi, for the advantage of manipulating the inner guide member (14) of Drontle, such that the curved distal portion (16) of the inner guide member (14) of Drontle can be manipulated from outside the patient while in use (see Paragraph 0041 and Figures 6A-6C of Drontle and Paragraph 0054 of Palushi).
Claim(s) 2, 7-11 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Drontle (US PGPub 2010/0312101) in view of Palushi (US PGPub 2020/0197670) as applied to claim 1 and 5 above, and further in view of Gerdts (US PGPub 2012/0123516).
Regarding Claim 2, the combination of references disclosed above teaches the apparatus of claim 1, wherein Drontle teaches the body assembly (12) having a proximal end (24; see Figure 1) but fails to disclose:
the guide rail having a proximal end positioned proximally in relation to the proximal end of the body assembly.
Gerdts teaches an apparatus for deploying an expandable element (Figure 1) which has an outer catheter/guide rail (16) and an inner catheter/dilation catheter (20; see Figure 1 and Figure 4; Paragraph 0027) wherein the inner dilation catheter (20) carries an expandable element (34; Figure 35), wherein the guide rail (16) has a proximal end (58; see Figure 6) positioned proximally in relation to the proximal end of the body assembly (14; see Figure 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the guide rail of Drontle to extend proximally past the proximal end of the handle, as taught by Gerdts for the advantage of assisting the clinician in placing, holding removing, or exchanging a guidewire (or the rigid inner guide member of Drontle) through the inner member (20; which is analogous to the balloon catheter of Drontle; see Paragraph 0045; Gerdts).
Regarding Claim 7, the combination of references disclosed above teaches the apparatus of claim 5, but fails to disclose further comprising one or more locking features configured to maintain the guide rail actuation assembly in the distal position relative to the body assembly.
Gerdts teaches an apparatus for deploying an expandable element (Figure 1) which has an outer catheter/guide rail (16) and an inner catheter/dilation catheter (20; see Figure 1 and Figure 4; Paragraph 0027) wherein the inner dilation catheter (20) carries an expandable element (34; Figure 35), and an guide rail actuation assembly (18; Figure 1), wherein the apparatus (10) further comprising one or more locking features (70; Figures 8-12) configured to maintain the guide rail actuation assembly in the distal position relative to the body assembly (see Paragraph 0051).
It would have been obvious to one of ordinary skill in the art to modify the invention of the combination of reference to include a locking member, as taught by Gerdts, for the advantage of providing unwanted actuation of the actuation member (Paragraph 0051; Gerdts).
Regarding Claim 8, the combination of references disclosed above teaches the apparatus of claim 7, wherein Gerdts teaches the one or more locking features (70) being configured to temporarily maintain the guide rail actuation assembly in the distal position relative to the body assembly (Paragraph 0054 discloses a releasable locking member and thus the guide rail actuation assembly can be locked in any position).
Regarding Claim 9-10, the combination of references disclosed above teaches the apparatus of claim 7, wherein Gerdts teaches the one or more locking features comprising one or more detent/latching features (Paragraph 0056-0058).
Regarding Claim 11, the combination of references disclosed above teaches the apparatus of claim 7, wherein Gerdts teaches the one or more locking features (70) being configured to permanently maintain the guide rail actuation assembly at the distal position (Paragraph 0053; the Examiner notes that permanently is an intended use and the locking member 70 can be left on the actuation assembly indefinitely in the distal position if the operation requires it).
Regarding Claim 16, the combination of references disclosed above teaches the apparatus of claim 1, but fails to disclose the dilation catheter being longitudinally fixed relative to the body assembly.
Gerdts teaches an apparatus for deploying an expandable element (Figure 1) which has an outer catheter/guide rail (16) and an inner catheter/dilation catheter (20; see Figure 1 and Figure 4; Paragraph 0027) wherein the inner dilation catheter (20) carries an expandable element (34; Figure 35), and an guide rail actuation assembly (18; Figure 1), wherein the apparatus (10) further comprising one or more locking features (70; Figures 8-12) configured to maintain the guide rail actuation assembly in the distal position relative to the body assembly (see Paragraph 0051). The examiner notes that this configuration would make the dilation catheter of Drontle longitudinally fixed to the body assembly since movement of the actuation assembly moves both the guide rail and the dilation catheter together in unison.
It would have been obvious to one of ordinary skill in the art to modify the invention of the combination of reference to include a locking member, as taught by Gerdts, for the advantage of providing unwanted actuation of the actuation member and thus the dilation catheter of Drontle (Paragraph 0051; Gerdts).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Drontle (US PGPub 2010/0312101) in view of Palushi (US PGPub 2020/0197670) as applied to claim 5 above, and further in view of Lesch (US Patent 2013/0123833).
Regarding Claim 6, the combination of references disclosed above teaches the apparatus of any of claim 5, but fails to disclose the guide rail actuation assembly being resiliently based toward the proximal position relative to the body assembly.
Lesch teaches a device for treating sinusitis comprising a body (212; Figure 1A), a guide rail (215; Figure 1A), a dilation catheter (217; Figure 1A) with a expandable element (218; Figure 1A) configured to dilate a passageway within a head of a patient (Paragraph 0021) and an actuation assembly (232) to drive the guide rail (215) longitudinally between proximal (Figure 1A) and distal (Figure 1B) positions relative to the body (212; Figures 1A-1B), wherein the guide rail actuation assembly (232) is resiliently biased toward the proximal position relative to the body assembly (212) when the dilation catheter (215) contacts the atraumatic tip (225) of the inner guide (213; see Figures 1A-1B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the actuation assembly of Drontle to include a resilient member, as taught by Lesch, for the advantage of providing tactile feedback to the user such that the dilation member does not extend past the inner member of Drontle.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Drontle (US PGPub 2010/0312101) in view of Palushi (US PGPub 2020/0197670) as applied to claim 1 above, and further in view of Forsberg (US PGPub 2019/0038817).
Regarding Claim 12, the combination of references disclosed above teaches the apparatus of claim 1, but fails to disclose the guide rail actuation assembly being further operable to drive rotational movement of the guide rail relative to the body assembly.
Palushi teaches a medical device which has a body (102) a guide rail (106), and a guide rail actuation assembly (108; Figure 2) in which the guide rail actuation assembly (108) is detachable from the body (102) and thus would be operable to allow for driven rotational movement of the guide rail (106) relative to the body (102) as a user holds onto element 108 and rotates the entire distal end of the device relative to the body (102; see Figure 2).
It would have been obvious to one of ordinary skill in the art to modify the device of Drontle to have a detachable guide rail actuation assembly from the body assembly, as taught by Palushi, for the advantage of rotating the guide rail relative to the inner guide member to reorient the device in an optimal delivery state.
Allowable Subject Matter
Claim 18 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 prior art of record fails to disclose:
the guide rail actuation assembly comprising a first translating member, the dilation catheter actuation assembly comprising a second translating member, the first translating member being configured to restrict distal movement of the second translating member when the guide rail is at the proximal position.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MOHAMED GAMIL GABR
Primary Examiner
Art Unit 3771
/MOHAMED G GABR/Primary Examiner, Art Unit 3771