DETAILED ACTION
The following Office Action is in response to the Non-Provisional Patent Application filed on May 6, 2025. Claims 1-20 are currently pending.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim Objections
Claim 1 is objected to because of the following informalities: Line 10 of the claim recites the phrase “a lumen extending between to the proximal and distal hubs”, wherein the word “to” appears to be mistakenly inserted. 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 9-15 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. Line 8 of claim 9 recites the limitation of “the hub”. However, it is indefinite as to whether this limitation refers to “the proximal hub” previously recited in the claim, “the distal hub” later recited in the claim, or a completely different hub altogether. For the purposes of compact prosecution, “the hub” will be interpreted as “the proximal hub”, consistent with the Specification and similar claim 5. Claims 10-15 are further rejected for being dependent on an indefinite claim.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, and 16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Campbell et al. (US 2012/0172927) in view of Borillo et al. (US 2002/0022860, hereinafter Borillo).
Concerning claim 1, the Campbell et al. prior art reference teaches a left atrial appendage (LAA) occlusion implant (Figures 1-8; 100), comprising: a proximal portion comprising multiple sized leaflets (Figure 2; 102) coupled to a proximal hub (Figure 1; 114) adapted to engage the atrial wall around the LAA and sized not to obstruct blood flow through the mitral valve or the pulmonary vein, and a barrier covering the multiple sized leaflets (Figure 2; 104), the barrier being adapted to prevent blood clots from passing through the LAA; a distal portion comprising an expandable anchor (Figure 1; 106) coupled to a distal hub (Figure 1; 113) adapted to expand within the LAA to assist in anchoring the implant in place; and a tubular element having a lumen extending between the proximal and distal hubs (Figure 1; 110), but it does not specifically teach the expandable anchor being an expandable bulb adapted to inflate within the LAA.
However, the Borillo reference teaches a left atrial appendage (LAA) occlusion implant similar to that of the Campbell reference, wherein the Borillo reference teaches a proximal portion comprising a barrier (Figure 5a; 510) and a distal portion comprising an expandable anchor adapted to inflate within the LAA to assist in anchoring the implant in place (Figure 5a; 531), wherein the barrier and the expandable anchor are connected via a connector (Figure 5a; 521), and wherein the reference further teaches embodiments where the anchor may be bulb shaped (Figure 1B; 140).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to replace the expandable anchor of the Campbell reference with an expandable bulb anchor adapted to inflate within the LAA as in the Borillo reference as a simple substitution of one known expandable anchor for a LAA occlusion implant (expandable anchor legs of Campbell) for another known expandable anchor for a LAA occlusion implant (expandable bulb shaped balloon of Borillo) which would yield the predictable result of anchoring in the same manner as the balloon embodiment of the Borillo reference and would perform equally as well.
Concerning claim 2, the combination of the Campbell and Borillo references as discussed above, wherein the Campbell reference further teaches an embodiment where the tubular element including a plurality of struts formed in the tubular member leaving the proximal and distal hubs (Figure 16A; 124).
Concerning claim 16, the Campbell et al. prior art reference teaches a left atrial appendage (LAA) occlusion implant (Figures 1-8; 100), comprising: a reinforcing frame comprising a plurality of reinforcing elements (Figure 2; 102) coupled to a proximal end of a connector having a lumen (Figure 1; 114), and a barrier coupled to the reinforcing frame adapted to engage the atrial wall around the LAA and prevent blood from entering the LAA (Figure 2; 104), a distal expandable anchor (Figure 1; 106) coupled to a distal end of the connector (Figure 1; 113), the expandable anchor adapted to expand within the LAA to assist in anchoring the implant in place; wherein the connector comprises a coil spring configured to add flexibility to the implant (Figure 1; 110 | [¶ 0066]), but it does not specifically teach the expandable anchor being an expandable bulb adapted to inflate within the LAA.
However, the Borillo reference teaches a left atrial appendage (LAA) occlusion implant similar to that of the Campbell reference, wherein the Borillo reference teaches a proximal portion comprising a barrier (Figure 5a; 510) and a distal portion comprising an expandable anchor adapted to inflate within the LAA to assist in anchoring the implant in place (Figure 5a; 531), wherein the barrier and the expandable anchor are connected via a connector (Figure 5a; 521), and wherein the reference further teaches embodiments where the anchor may be bulb shaped (Figure 1B; 140).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to replace the expandable anchor of the Campbell reference with an expandable bulb anchor adapted to inflate within the LAA as in the Borillo reference as a simple substitution of one known expandable anchor for a LAA occlusion implant (expandable anchor legs of Campbell) for another known expandable anchor for a LAA occlusion implant (expandable bulb shaped balloon of Borillo) which would yield the predictable result of anchoring in the same manner as the balloon embodiment of the Borillo reference and would perform equally as well.
Claims 3-4 and 19-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Campbell et al. (US 2012/0172927) in view of Borillo et al. (US 2002/0022860, hereinafter Borillo) as applied to claims 1, 2, and 16 above, and further in view of Pappu (US 2005/0004641).
Concerning claims 3-4 and 19-20, the combination of the Campbell and Borillo references as discussed above teaches the implant of claims 1 and 16, but does not teach the expandable bulb including cardiac monitoring and/or pacing capabilities.
However, the Pappu reference teaches a left atrial appendage occlusion implant similar to that of the Campbell and Borillo references, wherein the Pappu reference teaches a distal bulb that includes sensing/stimulating electrodes for cardiac monitoring/pacing ([¶ 0014]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to have the distal bulb of the Campbell and Borillo combination include sensing/stimulating electrodes for cardiac monitoring/pacing as in the Pappu reference to treat atrial fibrillation or other arrhythmias of the atrial appendage so that the formation of blood clots within the atrial appendage is decreased or eliminated (Pappu; [¶ 0012]).
Claims 5, 7-8, and 17-18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Campbell et al. (US 2012/0172927) in view of Borillo et al. (US 2002/0022860, hereinafter Borillo) as applied to claims 1, 2, and 16 above, and further in view of Lesh et al. (US 6,152,144).
Concerning claim 5, the combination of the Campbell and Borillo references as discussed above teaches the implant of claim 1, but does not teach an anchoring element comprising a plurality of anchors coupled to the proximal hub extending distally and adapted to expand in the LAA and anchor the implant in place.
However, the Lesh reference teaches a left atrial appendage occlusion implant including an expandable distal bulb similar to that of the Campbell and Borillo reference, wherein the Lesh reference further teaches an anchoring element comprising a plurality of anchors (Lesh; Figure 15; 125) adapted to expand in the LAA and anchor the implant in place.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to have the expandable distal bulb of the Campbell and Borillo combination include the anchoring element of the Lesh reference to mechanically interlock with surface irregularities within the LAA to help anchor the implant (Lesh; Column 11, Line 39 – Column 12, Line 9), wherein given the expandable distal bulb is attached to and extends distally from the proximal hub via the tubular element, the anchoring element may also be described as being coupled to and extending distally from the proximal hub (via the tubular element and distal bulb).
Concerning claims 7-8 and 17-18, the combination of the Campbell and Borillo references as discussed above teaches the implant of claims 1 and 16, but does not teach a casting material injected through the lumen of the tubular element into the LAA, the casting material being configured to solidify within the LAA.
However, the Lesh reference teaches a left atrial appendage occlusion implant similar to that of the Campbell and Borillo combination, wherein the Lesh reference further teaches that a casting material may be injected into the LAA, the casting material configured to solidify within the LAA (Lesh; Column 4, Lines 55-67), wherein said casting material may be fibrin, which may be described as a sclerosant given it may trigger sclerosis which may ultimately cause the LAA to shrink.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to have the implant of the Campbell and Borillo combination include a casting material injected through the lumen of the tubular element as in the Lesh reference to further occlude the LAA of the patient (Lesh; Column 4, Lines 55-67).
Claims 9 and 11-13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Campbell et al. (US 2012/0172927) in view of Borillo et al. (US 2002/0022860, hereinafter Borillo) and Lesh et al. (US 6,152,144).
Concerning claim 9, the Campbell et al. prior art reference teaches a left atrial appendage (LAA) occlusion implant (Figures 1-8; 100), comprising: a proximal portion comprising multiple sized leaflets (Figure 2; 102) coupled to a proximal hub (Figure 1; 114) adapted to engage the atrial wall around the LAA and sized not to obstruct blood flow through the mitral valve or the pulmonary vein, and a barrier covering the multiple sized leaflets (Figure 2; 104), the barrier being adapted to prevent blood clots from passing through the LAA; a distal portion comprising an expandable anchor (Figure 1; 106) coupled to a distal hub (Figure 1; 113) adapted to expand within the LAA to assist in anchoring the implant in place; and a tubular element having a lumen extending between the proximal and distal hubs (Figure 1; 110), but it does not specifically teach the expandable anchor being an expandable bulb adapted to inflate within the LAA nor does it teach an anchoring element coupled to the proximal hub extending distally and adapted to expand in the LAA and anchor the implant in place.
However, the Borillo reference teaches a left atrial appendage (LAA) occlusion implant similar to that of the Campbell reference, wherein the Borillo reference teaches a proximal portion comprising a barrier (Figure 5a; 510) and a distal portion comprising an expandable anchor adapted to inflate within the LAA to assist in anchoring the implant in place (Figure 5a; 531), wherein the barrier and the expandable anchor are connected via a connector (Figure 5a; 521), and wherein the reference further teaches embodiments where the anchor may be bulb shaped (Figure 1B; 140).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to replace the expandable anchor of the Campbell reference with an expandable bulb anchor adapted to inflate within the LAA as in the Borillo reference as a simple substitution of one known expandable anchor for a LAA occlusion implant (expandable anchor legs of Campbell) for another known expandable anchor for a LAA occlusion implant (expandable bulb shaped balloon of Borillo) which would yield the predictable result of anchoring in the same manner as the balloon embodiment of the Borillo reference and would perform equally as well.
Furthermore, the Lesh reference teaches a left atrial appendage occlusion implant including an expandable distal bulb as in the Campbell and Borillo combination, wherein the Lesh reference further teaches an anchoring element comprising a plurality of anchors (Lesh; Figure 15; 125) adapted to expand in the LAA and anchor the implant in place.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to have the expandable distal bulb of the Campbell and Borillo combination include the anchoring element of the Lesh reference to mechanically interlock with surface irregularities within the LAA to help anchor the implant (Lesh; Column 11, Line 39 – Column 12, Line 9), wherein given the expandable distal bulb is attached to and extends distally from the proximal hub via the tubular element, the anchoring element may also be described as being coupled to and extending distally from the proximal hub (via the tubular element and distal bulb).
Concerning claim 11, the combination of the Campbell, Borillo, and Lesh references as discussed above teaches the implant of claim 9, wherein the Campbell reference further teaches an embodiment where the tubular element including a plurality of struts formed in the tubular member leaving the proximal and distal hubs (Figure 16A; 124).
Concerning claims 12 and 13, the combination of the Campbell, Borillo, and Lesh references as discussed above teaches the implant of claim 9, wherein the Lesh reference further teaches that a casting material may be injected into the LAA, the casting material configured to solidify within the LAA (Lesh; Column 4, Lines 55-67), wherein said casting material may be fibrin, which may be described as a sclerosant given it may trigger sclerosis which may ultimately cause the LAA to shrink.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to have the implant of the Campbell and Borillo combination include a casting material injected through the lumen of the tubular element as in the Lesh reference to further occlude the LAA of the patient (Lesh; Column 4, Lines 55-67).
Claim 14-15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Campbell et al. (US 2012/0172927) in view of Borillo et al. (US 2002/0022860, hereinafter Borillo) and Lesh et al. (US 6,152,144) as applied to claims 9 and 11-13 above, and further in view of Pappu (US 2005/0004641).
Concerning claims 14 and 5, the combination of the Campbell and Borillo references as discussed above teaches the implant of claim 1, but does not teach the expandable bulb including cardiac monitoring and/or pacing capabilities.
However, the Pappu reference teaches a left atrial appendage occlusion implant similar to that of the Campbell and Borillo references, wherein the Pappu reference teaches a distal bulb that includes sensing/stimulating electrodes for cardiac monitoring/pacing ([¶ 0014]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to have the distal bulb of the Campbell and Borillo combination include sensing/stimulating electrodes for cardiac monitoring/pacing as in the Pappu reference to treat atrial fibrillation or other arrhythmias of the atrial appendage so that the formation of blood clots with the atrial appendage is decreased or eliminated (Pappu; [¶ 0012])
Allowable Subject Matter
Claim 6 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Van Tassel et al. reference (US 2003/0120337) teaches a LAA occlusion implant including sensing and monitoring capabilities; the Miles et al. reference (US 2009/0112249) teaches a LAA occlusion implant with embodiments including a barrier and anchor and a casting material; the Oral et al. reference (US 2013/0018413) teaches a LAA occlusion implant including a barrier and an expandable distal bulb; and the Erzberger et al. reference (US 2013/0218192) teaches a LAA occlusion implant including multiple sized leaflets, a barrier, and a distal expandable frame.
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/MARTIN T TON/Examiner, Art Unit 3771 7/17/2026
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