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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 3/5/2025, 6/24/2025, 10/2/2025 and 2/10/2026 have been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
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.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 2-8 are objected to because of the following informalities:
In claim 2 (and thereby dependent claims 3-8), there is a minor instance of rough grammar in line 14 at “disposed over the conduit, sheath” (wherein a minor amendment such as “disposed over the conduit, the sheath” will moot this objection).
Appropriate correction is required.
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.
Claim(s) 2, 6-9, 13-16 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Ma (US 2016/0331381) in view of Greene, Jr. et al. (US 2017/0367713).
Ma discloses (see Figs. 1-5) an implant delivery system with an electrolytic detachment comprising the following claim limitations:
(claim 2) A treatment system (10, Fig. 1) comprising: a conduit comprising: an electrically conductive body (31/33, Fig. 5) comprising a proximal portion (at 31), a distal portion (at 33), and a detachment zone (30, Fig. 5) between the proximal portion (31) and the distal portion (33) (as shown in Fig. 5), wherein the detachment zone (30) is configured to be (i.e., capable of) severed in response to a flow of an electrical current therethrough, thereby causing separation of the proximal portion (31) and the distal portion (33) ([0046]; detachment via electrical current applied to exposed detachment zone 30); an expandable occlusive member (20, Fig. 1) having a proximal hub (50, Fig. 5) coupled to the conduit distal portion (33) (as expressly shown in Fig. 5), the occlusive member (20) configured to be (i.e., capable of) deployed within an aneurysm (2, Fig. 3) (as shown in Fig. 3; [0041]); and an electrically insulative sheath (32/34, Fig. 5) disposed over the conduit (31/33) (as shown in Fig. 5), the sheath comprising: a proximal portion (34) extending over the conduit proximal portion (31) (as shown in Fig. 5); a distal portion (32) extending over the conduit distal portion (33) (as shown in Fig. 5); and a gap (i.e., gap exposes outer surface of detachment zone 30) between the proximal and the distal portion (as shown in Fig. 5), wherein the gap is axially aligned with the conduit detachment zone (30) (as shown in Fig. 5);
(claims 6, 13 and 20) wherein the occlusive member (20) comprises an expandable mesh (as shown in Figs. 1-5; [0039]; [0042]; implant 20 expressly may comprise a braid/mesh ball or other shaped stent-like objects) having a constrained state for delivery to an aneurysm ([0041]; implant 20 can be delivered to an aneurysm 2 while compressed/disposed within a delivery system catheter) and an expanded state in which at least a portion of the mesh is configured to be (i.e., capable of) disposed across a neck (9) of the aneurysm (2) (as expressly shown in Fig. 3);
(claims 7, 14 and 21) wherein the occlusive member (20) is at least partially collapsible (i.e., capable of collapsing) when contacted by an embolic element ([0039]; [0041]; implant 20 expressly disclosed to be composed of a resilient/collapsible material such as Nitinol which is fully capable of collapse when contacted by an embolic material);
(claim 9) A treatment system (10, Fig. 1) comprising: an electrically conductive conduit (31/33, Fig. 5) comprising: a proximal portion (at 31), a distal portion (at 33), and a detachment zone (30, Fig. 5) between the proximal portion (31) and the distal portion (33) (as shown in Fig. 5); an expandable occlusive member (20, Fig. 1) having a proximal end portion (50, Fig. 5) coupled to the conduit distal portion (33) (as expressly shown in Fig. 5), the occlusive member (20) configured to be (i.e., capable of) deployed within an aneurysm (2) (as expressly shown in Fig. 3); a first electrically insulative material (34, Fig. 5) extending over the conduit proximal portion (31) (as shown in Fig. 5; [0045]-[0047]); and a second electrically insulative material (32, Fig. 5) extending over the conduit distal portion (33) (as shown in Fig. 5; [0045]-[0047]), wherein the detachment zone (30) of the conduit is uninsulated (as expressly shown in Fig. 5; [0044]; [0046]); and
(claim 16) A treatment system (10, Fig. 1) comprising: a conduit comprising: an electrically conductive body (31/33, Fig. 5) comprising a proximal portion (at 31), a distal portion (at 33), and a detachment zone (30, Fig. 5) between the proximal portion (31) and the distal portion (33) (as shown in Fig. 5), wherein the proximal portion (31) and the distal portion (33) are covered with electrically insulative material (34/32, Fig. 5) ([0045]-[0047]) and wherein the detachment zone (30) is uncovered by electrically insulative material (as shown in Fig. 5; [0044]; [0046]-[0048]); and an expandable occlusive member (20, Fig. 1) having a proximal end portion (50, Fig. 5) coupled to the conduit distal portion (33) (as expressly shown in Fig. 5).
Ma, as applied above, discloses an implant delivery system with an electrolytic detachment comprising all the limitations of the claim except for the conduit being tubular having a lumen, and a distal opening in communication with the lumen, wherein the conduit is configured to pass a liquid embolic distally through the lumen and out of the distal opening.
However, Greene teaches (see Figs. 17-18) a highly similar aneurysm occluder (210, Figs. 17-18) having an electrolytic detachment ([0097]; electrolytic detachment systems expressly disclosed) comprising a conduit (230, Figs. 17-18) being tubular having a lumen ([0096]-[0097]; liquid embolic expressly delivered through a lumen within conduit tube 230), and a distal opening in communication with the lumen (as shown in Figs. 17-18, wherein liquid embolic 234 is shown exiting a distal opening of conduit 230), wherein the conduit (230) is configured to (i.e., capable of) pass a liquid embolic (234, Figs. 17-18) distally through the lumen and out of the distal opening (as shown in Figs. 17-18; [0096]-[0097]) in order to beneficially improve and enhance occlusion within an aneurysm by delivering additional embolic agents, including liquid embolic and/or other agents including embolic coils or meshes ([0096]-[0097]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Ma to have the conduit being tubular having a lumen, and a distal opening in communication with the lumen, wherein the conduit is configured to pass a liquid embolic distally through the lumen and out of the distal opening in order to beneficially improve and enhance occlusion within an aneurysm by delivering additional embolic agents, including liquid embolic and/or other agents including embolic coils or meshes, as taught by Greene.
Claim(s) 3-5, 10-12 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ma in view of Greene, as applied to claims 2, 9 and 16 above.
Ma in view of Greene, as applied above, discloses an implant delivery system with an electrolytic detachment comprising all the limitations of the claim except for the conduit having a wall thickness of between about 0.0005 inches and about 0.0015 inches, an outer diameter of less than about 0.027 inches, and an inner diameter of less than about 0.015 inches.
With regard to claims 3-5, 10-12 and 17-19, it would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the conduit of Ma in view of Greene (which teaches the claimed structures for performing the same function) to comprises a wall thickness of between about 0.0005 inches and about 0.0015 inches, an outer diameter of less than about 0.027 inches, and an inner diameter of less than about 0.015 inches, since it has been held that where the general conditions of a claim are disclosed in the prior art, merely discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
Prosecution Insights