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 .
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: “mechanism to rotate the cylinder” in claim 5, 11, and 12.
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.
The specification discloses in [0042] “the instrument 250 may include a mechanism to provide for controlled rotation of the cylinder 254, such as a mechanical lever or electronic switch coupled to the cylinder 254 via the shaft and located on a proximal handle of the instrument 250”. Therefore, a mechanical lever, electronic switch, or any structural equivalent will be interpreted as meeting the limitation of the mechanism.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 7, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pugsley et al. (US 2004/0225247).
Regarding claim 1, Pugsley et al. discloses a medical system (30, FIGs 5A-5B and 9-11C), comprising: a patch comprising a biocompatible material (10 or110, FIG 2-3, [0051, 0063]); and an instrument (remainder of delivery system in FIG 5A, [0057]) configured to be introduced into a working channel of an endoscope (The catheter system is at least sized and shaped to be inserted into a large enough working channel of an endoscope. [0066] discloses use of an endoscope within the procedure), the instrument comprising: a shaft (30), and a cylinder (33) disposed at a distal end of the shaft (FIG 5A-5B), wherein the patch is configured to be coupled to the cylinder ([0063, 0065-0067] in the delivery configuration, the path 110 is in direct contact with the cylinder and therefore is coupled), and wherein the cylinder is rotatable relative to the shaft (33 is not attached or constrained to shaft 30 and can be retracted or rotated freely relative thereto).
Regarding claim 2, Pugsley et al. disclose a cross-sectional size of the cylinder is greater than a cross-sectional size of the shaft (FIG 9 and 11A).
Regarding claim 7, Pugsley et al. disclose the patch further comprises an adhesive disposed on at least one surface of the patch ([0012, 0062, 0065, 0067]).
Regarding claim 10, Pugsley et al. disclose the patch is releasable from the cylinder ([0065-0067]).
Claim(s) 1, 3-6, 8-9, and 11-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Widomski et al. (US 2005/0288706).
Regarding claim 1, Widomski et al. discloses a medical system (30, FIGs 5A-5F), comprising: a patch comprising a biocompatible material (occluder 10 forms a biocompatible patch 12 because it is made of a biocompatible material, [0042-0046], and acts as a patch by covering and closing a defect wall by being adhesively attached thereto, [0013, 0054-0055]); and an instrument (remainder of delivery system in FIG 5A ) configured to be introduced into a working channel of an endoscope (The catheter system is at least sized and shaped to be inserted into a large enough working channel of an endoscope), the instrument comprising: a shaft (34), and a cylinder (38, [0059]; the threaded coupling mechanism at the distal end of 36 is interpreted as a cylinder because it comprises a cylinder as a base underneath the threads) disposed at a distal end of the shaft (FIG 5A-5B), wherein the patch is configured to be coupled to the cylinder (via proximal coupling 20 of the patch, FIGs 5A-5E show the coupled and uncoupled stated, [0059 and 0064]), and wherein the cylinder is rotatable relative to the shaft (36 is rotated to rotated 38 out of threaded engagement with 20, [0064]. This occurs while 34 remains stationary).
Regarding claim 3-4, Widomski et al. discloses the cylinder comprises a raised surface at a proximal end of the cylinder (the external threads of 38 are interpreted as raised surface on the cylinder) wherein the raised surface is configured to maintain a position of the patch on the cylinder (The threads maintain the position of the patch on the cylinder by engaging with the female threaded coupler of the patch).
Regarding claim 5-6, Widomski et al. discloses a mechanism (41) coupled to the shaft ([0060], FIG 5A) and disposed on a proximal handle (37) of the instrument, wherein the mechanism is configured to rotate the cylinder relative to the shaft ([0067]; “The occluder 10 is released from the catheter 36 as shown in FIG. 6G, e.g., by actuating button a 41 on the handle 37 to transition the coupling mechanism 38 into an open or disengaged position to disconnect the coupling mechanism 38 from the occluder 10”. Since the coupling mechanism can be a threaded engagement, it is understood that decoupling requires rotation of the cylinder), wherein the mechanism comprises one of a mechanical lever or an electronic switch (41 is disclosed as an actuator button, [0060], which is understood to have an electronic switch to act as a button that causes rotation).
Regarding claim 1, Widomski et al. discloses in an alternative interpretation a medical system (30, FIGs 5A-5F), comprising: a patch comprising a biocompatible material (occluder 10 forms a biocompatible patch 12 because it is made of a biocompatible material, [0042-0046], and acts as a patch by covering and closing a defect wall by being adhesively attached thereto, [0013, 0054-0055]); and an instrument (remainder of delivery system in FIG 5A ) configured to be introduced into a working channel of an endoscope (The catheter system is at least sized and shaped to be inserted into a large enough working channel of an endoscope), the instrument comprising: a shaft (36), and a cylinder (20, FIG 4 and 5A-5E) disposed at a distal end of the shaft (FIG 5A), wherein the patch is configured to be coupled to the cylinder (FIG 4, the patch 12 is coupled to port 20, [0034-0040]), and wherein the cylinder is rotatable relative to the shaft (20 is rotated relative to 36 to couple or decouple the threaded engagement therebetween, [0040,0059, 0064]).
Regarding claim 8-9, Widomski et al. discloses in the alternative interpretation a catheter disposed (34) about an outer surface of the shaft (FIG 5A), wherein the catheter is configured to surround the patch (FIG 5A).
Regarding claim 11, Widomski et al. discloses a medical system (30, FIGs 5A-5F), comprising: a patch comprising a biocompatible material (occluder 10 forms a biocompatible patch 12 because it is made of a biocompatible material, [0042-0046], and acts as a patch by covering and closing a defect wall by being adhesively attached thereto, [0013, 0054-0055]); and an instrument (remainder of delivery system in FIG 5A ) comprising: a shaft (34); a cylinder (38, [0059]; the threaded coupling mechanism at the distal end of 36 is interpreted as a cylinder because it comprises a cylinder as a base underneath the threads) disposed at a distal end of the shaft (FIG 5A-5B); and a mechanism (41) configured to rotate the cylinder relative to the shaft ([0067]; “The occluder 10 is released from the catheter 36 as shown in FIG. 6G, e.g., by actuating button a 41 on the handle 37 to transition the coupling mechanism 38 into an open or disengaged position to disconnect the coupling mechanism 38 from the occluder 10”. Since the coupling mechanism can be a threaded engagement, it is understood that decoupling requires rotation of the cylinder); wherein the patch is coupled to (FIG 5A) and releasable from (FIG 5E) the cylinder).
Regarding claim 12, Widomski et al. discloses the instrument further comprises a handle (37), and wherein the mechanism is disposed on the handle (FIG 5A, [0059-0060]).
Regarding claim 13, Widomski et al. discloses a proximal end of the cylinder comprises a raised surface (the external threads of 38 are interpreted as raised surface on the cylinder), and wherein the raised surface is configured to prevent proximal movement of the patch relative to the cylinder (The threads maintain the position of the patch relative to the cylinder by engaging with the female threaded coupler of the patch and preventing translational movement between the two until the threads are disengaged).
Regarding claim 14, Widomski et al. discloses the raised surface has an outer diameter greater than an outer diameter of a portion of the cylinder adjacent to the raised surface (The external threads of 38 have a greater diameter than the base which they are formed upon).
Regarding claim 15, Widomski et al. discloses the instrument is configured to be introduced into a working channel of an endoscope (The catheter system is at least sized and shaped to be inserted into a large enough working channel of an endoscope).
Regarding claim 16, Widomski et al. discloses the patch is disposed on an outer surface of the cylinder (20 of the patch surrounds the cylinder, FIG 5A and is disposed on an outer surface of the cylinder because it is in direct engagement with the threads thereof).
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) 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Pugsley et al. (US 2004/0225247) in view of Levy (US 2012/0065674).
Regarding claim 17-20, Pugsley et al. discloses a medical system (30, FIGs 5A-5B and 9-11C), comprising: a patch comprising a biocompatible material (10 or 110, FIG 2-3, [0051, 0053]); and an instrument (remainder of delivery system in FIG 5A, [0057]),the instrument comprising: a shaft (30), and a cylinder (33,35 and 40) disposed at a distal end of the shaft (FIG 5A-5B), wherein the patch is configured to be coupled to the cylinder ([0063, 0065-0067] in the delivery configuration, the patch 110 is in direct contact with the cylinder and therefore is coupled) and releasable from the cylinder ([0065-0067]; 110 is deployed from both 33 and 35), wherein the cylinder comprises a raised surface (at least 35 is interpreted as a raised surface, FIG 5B and 9-11C), and the patch is disposed on a surface of the cylinder distal to the raised surface (FIG 5B shows at least some portion of the patch is distal to a portion of 35), wherein a surface of the patch comprises an adhesive ([0012, 0062, 0065, 0067]) configured to secure the patch to the surface of the cylinder ([0012, 0062, 0065, 0067]), and wherein the cylinder is rotatable relative to the shaft (33 is not attached or constrained to shaft 30 and can be retracted or rotated freely relative thereto).
Pugsley further discloses in [0066] use of an endoscope within the procedure, but fails to disclose the instrument being disposed within a working channel of the endoscope.
However, Levy teaches in the same field of endeavor of delivering a patch (18) releasably attached to an instrument (14, FIG 1, [0030]) to an incision (26) of a tissue (24) accessed via the esophagus ([0028, FIG 10), wherein the instrument is disposed within a working channel of an endoscope (12, FIG 1A and 10, [0030, 0032]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the instrument of Pugsley to be disposed within the working channel of an endoscope, as taught by Levy, for the purpose of delivering to the instrument to the target treatment site using a known mechanism in the art with the added benefit of being able to visualize the treatment site using the endoscope.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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