DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Newly submitted claims 81-88 directed to an invention that lacks unity with the invention originally claimed for the following reasons: claims 81-88 are directed to a separate species of the generic invention.
The invention previously elected, directed to claims 60, 64-66, 70, 71, and 75-80, and the invention presented in new claims 81-88 are directed to more than one species of the generic invention.
The species are as follows:
Species A (claims 60, 64-66, 70, 71, and 75-80), directed to a method of using a delivery device comprising expanding a reconfigurable space-making element from the distal end of an elongated shaft of a delivery device to create or expand a working space at a desired location using the space-making element and directing a working end of a therapeutic device to the desired location through the elongated shaft.
Species B (claims 81-88), directed to a method of using a delivery device comprising inflating a reconfigurable space-maker having cavities tethered to one another, extending beyond an opening of the elongated shaft, to delineate a working cavity open at opposing ends to create or expand a working space at the desired location using the inflated space-maker and directing a working end of a therapeutic device to the desired location through the elongated shaft.
The species are patentably distinct because Species A expands the space making element, for example space making element 602, to create or expand a working space at the desired location. In contrast, Species B inflates cavities of a space-maker, for example cavities 2002, 2004, and 2006, wherein the working space is created or expanded by structural elements, for example elements 2020, 2022, which facilitate a desired spacing of the closed, inflated cavities, rather than the inflatable space-maker cavities themselves.
Since Applicant has received an action on the merits for the originally elected invention following the response to restriction requirement received 11/14/1025, this invention has been elected for prosecution on the merits. Accordingly, claims 81-88 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Claim Objections
In regards to Applicant’s response filed 03/04/2026, the amended claims have overcome the objections made in the Non-Final Office Action filed 12/17/2025. The objections are hereby withdrawn.
Rejections under 35 USC 112(b)
In regards to Applicant’s response filed 03/04/2026, the amended claims have overcome the rejections under 35 USC 112(b) made in the Non-Final Office Action filed 12/17/2025, and are hereby withdrawn.
Rejections under 35 USC 102/103
Applicant’s arguments, see Remarks filed 03/04/202, with respect to the rejection(s) of claims 60, 64-66, 70, 71, 75-80 under 35 USC 102/35 USC 103 in view of Saadat have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Saadat and Fogarty. Specifically, Saadat does not disclose the amended features of a first portion of a reconfigurable space-maker circumscribing the elongated shaft and a second portion of the reconfigurable space-maker positioned within and circumscribed by the elongated shaft; such that when the reconfigurable space-maker is expanded, the second portion of the reconfigurable space-maker is no longer positioned within and circumscribed by the elongated shaft. However, Fogarty does disclose these features, see 35 USC 103 rejection below.
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:
“a reconfigurable space-maker,” [for expanding from a retracted configuration to an expanded configuration from the distal end of the shaft] in claim 1, because “reconfigurable,” “space-mak[ing],” and expanding from a retracted to expanded configuration merely describe functions of the element without providing sufficient structure to perform the claimed functions. Examiner is interpreting the limitation in accordance with paragraph [0086] of the specification where the reconfigurable space-making element is configured to create or expand a working space, such as by separating biological tissues at the surgical site, thereby any structural element which can separate biological tissue to create/expand a working space may meet the limitation of the claim.
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 § 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 64-66, 70-71, and 75-77 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 64-66, 70-71, and 75-77 recite the limitation "the distal end portion of the elongated shaft.” There is insufficient antecedent basis for this limitation in the claim.
Claims 78-80 recite the limitation "the reconfigurable space-making element.” There is insufficient antecedent basis for this limitation in the claim.
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.
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.
Claims 60, 70, 71, and 75-80 are rejected under 35 U.S.C. 103 as being unpatentable over Saadat (US 20060184048 A1) in view of Fogarty et al (US 5979452 A).
Regarding claim 60, Saadat teaches a method of using a delivery device, comprising:
positioning an elongated shaft (catheter 16/210) of a delivery device (10) at a desired location (see Fig. 1A-C, [0072-0073]; catheter 14 having deployment catheter 16 at the distal end is introduced to the patient for tissue access), where a first portion of a reconfigurable space-maker interfaces with the elongated shaft (see [0073]; imaging hood 12 may be attached at interface 24 to deployment catheter 16) and a second portion of the reconfigurable space-maker is positioned within and circumscribed by the elongated shaft (see Fig. 14C, [0107]; hood 218 may be inverted or everted upon itself);
expanding the reconfigurable space-maker so the second portion of the reconfigurable space-maker is no longer positioned within and circumscribed by the elongated shaft (see Fig. 14C, [0107]; hood 218 may be rolled, inverted, or everted upon itself for deployment);
creating or expanding a working space at the desired location using the reconfigurable space-maker when expanded (see Figs. 1A-C, [0072-0073]; imaging hood 12 expands into a deployed configuration defining open area 26 where the tissue of interest is visualized); and
directing a working end of a therapeutic device (360) to the desired location through the elongated shaft via a longitudinally extending therapeutic device lumen (see annotated Fig. 30A below picturing unlabeled therapeutic device lumen of catheter 16 and/or articulatable delivery catheter 48, Figs. 30A-B, [0127]; instrument 360, which may be a tissue grabber, is delivered through catheter 16 for use within imaging hood 12 and/or [0079]; articulatable deliver catheter 48 may be delivered through catheter 16 and into imaging hood 12 to direct an instrument or tool passed through catheter 48).
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Saadat is silent regarding wherein the interface between the elongated shaft and a first portion of the reconfigurable space-maker comprises the first portion of the reconfigurable space-maker circumscribing the elongated shaft.
Fogarty teaches a method of using a delivery device (26) where a first portion of a reconfigurable space-maker circumscribed an elongated shaft (28) of the delivery device (see Fogarty annotated Figs. 10-11 below, [Col 7, lines 30-33]; the balloon is sealed to the distal tip of the trocar portion) and a second portion of the reconfigurable space-maker is positioned within and circumscribed by the elongated shaft (see annotated Figs. 10-11 below);
expanding the reconfigurable space-maker so the second portion is no longer circumscribed by the elongated shaft (see Fig. 11 where balloon is in fully extended state); and
directing a working end of a therapeutic device to the desired location through the elongated shaft (see Fogarty [Col 7, lines 45-50]; Fig 11 shows the balloon in its fully extended state with the lumen large enough for a laparoscope to be inserted).
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It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to use Fogarty’s eversion balloon catheter system with Saadat’s delivery device comprising a hood which may be everted upon itself. One of ordinary skill in the art would have been motivated to make this modification in order to separate tissue to establish a work space at the distal tip of the balloon which may accommodate endoscopic tools necessary for a procedure (Fogarty [Col 4, lines 50-60]).
Regarding claim 70, Saadat and Fogarty teach the method of claim 60. Saadat further teaches wherein positioning the distal end portion of the elongated shaft (16) of the delivery device (10) at the desired location (see Saadat [0073]; the imaging hood 12 at distal end of catheter 16 is positioned at the tissue of interest) comprises positioning the distal end portion proximate a left atrial appendage of a patient's heart (see Saadat [0070-0071]; the apparatus may be used for access to the left atrium).
Regarding claim 71, Saadat and Fogarty teach the method of claim 70. Saadat further teaches wherein positioning the distal end portion (distal end of catheter 16) proximate the left atrial appendage comprises advancing the distal end portion posterior to the patient's heart (see Saadat [0071]; the device can be used for accessing the left atrial chamber via the right atrial chamber in a trans-septal procedure or septostomy, it can be appreciated that the right atrium is the most anterior chamber and forms a significant part of the front heart wall, and the left atrium is the most posterior chamber forming a significant part of the back heart wall, therefore in order to position the distal end of the device in proximate the left atrial appendage, the device must advance in a posterior direction).
Regarding claim 75, Saadat and Fogarty teach the method of claim 60. Saadat further teaches wherein positioning the distal end portion of the elongated shaft (16) of the delivery device at the desired location comprises advancing the elongated shaft using a handle (112) disposed proximally on the elongated shaft (see Saadat Fig. 8B, [0092]; handle assembly 112 which can be held or manipulated by the physician from outside the patient body).
Regarding claim 76, Saadat and Fogarty teach the method of claim 75. Saadat further teaches wherein the distal end portion of the elongated shaft (16) is steerable by a steering actuator (126) disposed on the handle (112); and
wherein positioning the distal end portion of the elongated shaft (16) of the delivery device (110) at the desired location comprises operating the steering actuator (126) to steer the distal end portion of the elongated shaft (see Saadat Fig. 8B, [0094]; handle assembly 112 may incorporate one or more articulation controls 126 for positioning the catheter 16 at a desired position).
Regarding claim 77, Saadat and Fogarty teach the method of claim 76. Saadat further teaches wherein operating the steering actuator (126) to steer the distal end portion of the shaft comprises pulling a steering wire (42) extending longitudinally through the shaft (16) to deflect of the distal end portion (see Saadat [0078-0079]; push-pull wires 42 may be routed through the catheter for positioning of the distal end at a tissue of interest, [0094]; the handle 112 may incorporate controls 126 for manual articulation of the catheter 16).
Regarding claim 78, Saadat and Fogarty teach the method of claim 60. Saadat further teaches wherein the reconfigurable space-making element (174) comprises an inflatable space-making element (172); and
wherein expanding the reconfigurable space-making element comprises delivering an inflation fluid to the inflatable space-making element through a longitudinally disposed inflation lumen in the elongated shaft (see Saadat Fig. 11A, [0101]; once imaging hood 174 is deployed, balloon 172 may be filled with a fluid).
Regarding claims 79 and 80, Saadat and Fogarty teach the method of claim 60. Saadat further teaches wherein expanding the reconfigurable space-making element (12) comprises laterally and longitudinally expanding the reconfigurable space-making element (see Saadat [0073]; when deployed the imaging hood 12 may expand into any number of shapes including cylindrical, conical, semi-spherical, etc. and Figs. 1A-B where the imaging hood 12 is expanded in a circular manner which includes a lateral and longitudinal expansion). Examiner also points to Figs. 14A-20B which illustrate various methods of deployment of imaging hood 12.
Claims 64-66 are rejected under 35 U.S.C. 103 as being unpatentable over Saadat (US 20060184048 A1) in view of Fogarty et al (US 5979452 A) and Brock et al (US 20020087169 A1), which is incorporated by reference in its entirety by Saadat.
Regarding claim 64, Saadat and Fogarty teach the method of claim 60 wherein the shaft of catheter 16 is articulatable (see Saadat Fig. 5, [0083]; sheath 72 may be articulated through the heart to reach a tissue of interest and catheter 16 may be advanced out of sheath 72, so it can be appreciated that catheter 16 is articulated with sheath 72 to reach the target tissue). However, Saadat is silent regarding specifically wherein a proximal portion of the shaft is flexible in a first plane; and
wherein positioning the distal end portion of the shaft of the delivery device at the desired location comprises bending the proximal portion of the shaft in the first plane.
However, Saadat incorporates the robotically-controlled delivery catheter of Brock in its entirety, wherein Brock teaches a proximal portion (O1) of the shaft (KA) flexible in a first plane (see Brock Fig. 3A, [0212-0213]; operative segment O1 located at the proximal end of shaft KA to carry out a first manipulation to bend the shaft in a desired direction); and
wherein positioning the distal end portion (G) of the shaft of the delivery device at the desired location comprises bending the proximal portion of the shaft in the first plane (see Brock Fig. 3A, [0212-0213]; a surgeon manipulates the first operative segment O1 so that the shaft can experience controlled bends in order to reach an operative site).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the articulatable catheter of Saadat with the proximal operative sheath segment as taught by Brock. One of ordinary skill in the art would have been motivated to make this modification in order to articulate a shaft to hard-to-reach operative sites such as intricate body lumens by allowing the catheter to experience simultaneous controlled bends at locations throughout the shaft, including at a proximal portion.
Regarding claims 65 and 66, Saadat, Fogarty, and Brock teach the method of claim 64. Saadat further teaches wherein the distal end portion of the shaft is steerable in a first and second plane, the second plane generally perpendicular to the first plane (see annotated Fig. 3A below where arrows 46 demonstrate various directions the distal end may be manipulated, which includes a first and second plane that are generally perpendicular to one another); and
wherein positioning the distal end portion of the shaft of the delivery device at the desired location comprises steering the distal end portion of the shaft in the first and second plane (see Saadat Fig. 3A, [0078]; articulatable assembly 40 comprising catheter 16 is flexible at a distal end portion to desirably position the imaging hood 12 at the tissue of interest).
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Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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