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 Objections
Claims 12 and 242 are objected to because of the following informalities:
In claim 12, line 3, the term “atrium” appears to be misspelled.
In claim 242, the phrase “wherein moving” should read “wherein reducing a distance between” or similar language, to properly refer to the previous method step of reducing a distance between the first and second plurality of chordae tendineae, since the term “moving” has not specifically been recited in the previous claims.
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 device” in claim 246.
Paras. [0066]-[0068] and [0079]-[0080]+ of the instant spec. describe the locking device as a band, clip, ring, graspers and other locking structures. “Locking device” uses the generic placeholder “device” coupled with the term “locking”, which is functional in that the limitation alternatively recites a device for locking, and the term “device” is not preceded by a structural modifier since the term “locking” does not imply any structure.
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 41-46, 56 and 246 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.
Regarding claim 41, the claim recites “non-surgically engaging a plurality of chordae tendineae… non-surgically approximating… and non-surgically locking”. It is unclear what the metes and bounds of the term “non-surgically” are, therefore, the scope of the claim is indefinite. Applicant appears to be referring to minimally invasive surgical procedures due to paras. [0102]-[0104] describing surgery as surgically opening tissue such as the chest. However, applicant discloses several minimally invasive approaches in paras. [0094]-[0101] and figs. 38-43, which are still considered surgical procedures, such that it is unclear what the term “non-surgical” is referring to. For examination purposes, the phrase is interpreted to refer to a minimally invasive surgical procedure. It is suggested to amend the claim to engaging the tissue via a minimally invasive approach or similar language, as opposed to a non-surgical procedure.
Claims 42-46, 56 and 246 are indefinite due to their dependencies on indefinite base claim 41.
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) 1-6, 8, 22-23, 41-46, 56, 235-236 and 238-246 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Douk (US 2007/0255396 A1).
Regarding claim 1, Douk discloses (see abstract; paras. [0035]-[0062]; figs. 1-23) a method for treating a patient (para. [0059]), comprising:
delivering a distal portion of an elongate medical device (400, para. [0055]) into a ventricle (delivered into left ventricle, para. [0045]) of a beating closed heart of a subject (minimally invasive surgery considered to encompass surgery on a beating closed heart of a subject, para. [0046]) via a primary skin opening and a secondary puncture (delivered via percutaneous route through femoral artery, encompasses primary skin opening through skin and secondary puncture through femoral artery, paras. [0045]-[0046]);
utilizing the distal portion of the elongate medical device (includes 420, para. [0055]) to engage a plurality of chordae tendineae (figs. 9-18) extending from a first papillary muscle within the ventricle (depicted in figs. 9-18), at least a first one of the plurality of chordae tendineae attached to a first leaflet of an atrioventricular valve located between the ventricle and an adjacent atrium (attached to mitral valve, considered to be attached to a first leaflet of the mitral valve, figs. 9-18), and at least a second one of the plurality of chordae tendineae attached to a second leaflet of the atrioventricular valve (chordae tendineae depicted as attached to leaflets of mitral valve, considered to be attached to both leaflets of mitral valve, figs. 9-18);
approximating the engaged plurality of chordae tendineae (via girdle forming ring around chordae tendineae, paras. [0048]-[0049]; figs. 9-18) to increase an amount of closure possible between the first leaflet and the second leaflet (draws chords closer together, considered to increase an amount of closure between the leaflets, paras. [0048]-[0049]); and
locking the plurality of chordae tendineae in their approximated condition (via locking mechanism of girdle 420, paras. [0055]-[0058]; fig. 22).
Regarding claim 2, Douk discloses the method of claim 1. Douk further discloses wherein the atrioventricular valve comprises a mitral valve and the ventricle comprises a left ventricle (para. [0045]; figs. 9-18).
Regarding claim 3, Douk discloses the method of claim 1. Douk further discloses wherein the atrioventricular valve comprises a tricuspid valve and the ventricle comprises a right ventricle (includes access of tricuspid valve, considered to engage chords similarly and encompass accessing the right ventricle, para. [0046]).
Regarding claim 4, Douk discloses the method of claim 3. Douk further discloses wherein the first leaflet comprises an anterior leaflet, and wherein the second leaflet comprises a posterior leaflet (chordae tendineae of tricuspid valve are attached to each leaflet of tricuspid valve, device considered to engage chords similarly to mitral valve and encompass the anterior and posterior leaflets).
Regarding claim 5, Douk discloses the method of claim 3. Douk further discloses wherein the first leaflet comprises a posterior leaflet, and wherein the second leaflet comprises a septal leaflet (chordae tendineae of tricuspid valve are attached to each leaflet of tricuspid valve, device considered to engage chords similarly to mitral valve and encompass the posterior and septal leaflets).
Regarding claim 6, Douk discloses the method of claim 3. Douk further discloses wherein the first leaflet comprises an anterior leaflet, and wherein the second leaflet comprises a septal leaflet (chordae tendineae of tricuspid valve are attached to each leaflet of tricuspid valve, device considered to engage chords similarly to mitral valve and encompass the anterior and septal leaflets).
Regarding claim 8, Douk discloses the method of claim 1. Douk further discloses wherein the ventricle comprises a left ventricle, and the secondary puncture comprises a puncture of an artery (paras. [0045]-[0046]; figs. 9-18).
Regarding claim 22, Douk discloses the method of claim 1. Douk further discloses wherein the first papillary muscle comprises an anterolateral papillary muscle (engages chords within left ventricle, considered to encompass chords attached to anterolateral papillary muscle, figs. 9-18).
Regarding claim 23, Douk discloses the method of claim 1. Douk further discloses wherein the first papillary muscle comprises a posteromedial papillary muscle (engages chords within left ventricle, considered to encompass chords attached to posteromedial papillary muscle, figs. 9-18).
Regarding claim 235, Douk discloses the method of claim 1. Douk further discloses further comprising:
engaging a second plurality of chordae tendineae extending from a second papillary muscle within the ventricle (engages second plurality of chords extending from secondary papillary muscle, figs. 9-18), at least a first one of the second plurality of chordae tendineae attached to the first leaflet of the atrioventricular valve, and at least a second one of the second plurality of chordae tendineae attached to the second leaflet of the atrioventricular valve (considered to be attached to similar leaflets of mitral valve);
approximating the engaged second plurality of chordae tendineae (via girdle forming ring around chordae tendineae, paras. [0048]-[0049]; figs. 9-18) to further increase the amount of closure possible between the first leaflet and the second leaflet (draws chords from second papillary muscle towards chords from first papillary muscle and closer together, considered to further increase an amount of closure between the leaflets, paras. [0048]-[0049]); and
locking the second plurality of chordae tendineae in their approximated condition (via locking mechanism of girdle 420, paras. [0055]-[0058]; fig. 22).
Regarding claim 236, Douk discloses the method of claim 1. Douk further discloses wherein the primary skin opening comprises a puncture in the skin (percutaneous access comprises a skin puncture, paras. [0045]-[0046]).
Regarding claim 238, Douk discloses the method of claim 1. Douk further discloses wherein the approximating proceeds substantially along an anterior-posterior axis (circumferential approximating encompasses anterior-posterior axis, figs. 9-18).
Regarding claim 239, Douk discloses the method of claim 1. Douk further discloses wherein engaging comprises encircling (para. [0060]).
Regarding claim 240, Douk discloses the method of claim 1. Douk further discloses wherein engaging comprises grasping with a grasper (girdle 420 considered to function as a grasper).
Regarding claim 241, Douk discloses the method of claim 1. Douk further discloses wherein approximating comprises reducing a distance between the at least a first one of the plurality of chordae tendineae and the at least a second one of the plurality of chordae tendineae (draws chords closer together, encompasses reducing a distance, paras. [0048]-[0049]).
Regarding claim 242, Douk discloses the method of claim 241. Douk further discloses wherein moving the at least a first one of the plurality of chordae tendineae and the at least a second one of the plurality of chordae tendineae toward each other comprises causing the at least a first one of the plurality of chordae tendineae and the at least a second one of the plurality of chordae tendineae to contact each other (girdle considered to cause chords to contact each other when deployed and wrapped around chords, figs. 9-18).
Regarding claim 243, Douk discloses the method of claim 242. Douk further discloses wherein locking comprises placing a constricting band (band of 420) around the at least a first one of the plurality of chordae tendineae and the at least a second one of the plurality of chordae tendineae (figs. 9-18).
Regarding claim 244, Douk discloses the method of claim 1. Douk further discloses wherein locking comprises placing a constrictor (420) around the at least a first one of the plurality of chordae tendineae and the at least a second one of the plurality of chordae tendineae (figs. 9-18).
Regarding claim 245, Douk discloses the method of claim 1. Douk further discloses wherein locking comprises placing a clip (420 including ratchet-type locking mechanism considered to function as a clip, para. [0055]) around the at least a first one of the plurality of chordae tendineae and the at least a second one of the plurality of chordae tendineae (figs. 9-18).
Regarding claim 41, Douk discloses (see abstract; paras. [0035]-[0062]; figs. 1-23) a method for treating a patient (para. [0059]), comprising:
non-surgically engaging a plurality of chordae tendineae extending from a first papillary muscle within a ventricle (via 420, paras. [0045]-[0049] and [0055]; figs. 9-18), at least a first one of the plurality of chordae tendineae attached to a first leaflet of an atrioventricular valve located between the ventricle and an adjacent atrium (attached to mitral valve, considered to be attached to a first leaflet of the mitral valve, figs. 9-18), and at least a second one of the plurality of chordae tendineae attached to a second leaflet of the atrioventricular valve (chordae tendineae depicted as attached to leaflets of mitral valve, considered to be attached to both leaflets of mitral valve, figs. 9-18);
non-surgically approximating the engaged plurality of chordae tendineae (via girdle forming ring around chordae tendineae, paras. [0048]-[0049]; figs. 9-18) to increase an amount of closure possible between the first leaflet and the second leaflet (draws chords closer together, considered to increase an amount of closure between the leaflets, paras. [0048]-[0049]); and
non-surgically locking the plurality of chordae tendineae in their approximated condition (via locking mechanism of girdle 420, paras. [0055]-[0058]; fig. 22).
Regarding claim 42, Douk discloses the method of claim 41. Douk further discloses wherein non-surgically engaging is performed with a first elongate medical device (holding tube 430 advanced to engage chords, paras. [0045]-[0049] and [0055]).
Regarding claim 43, Douk discloses the method of claim 42. Douk further discloses wherein non-surgically approximating is performed with the first elongate medical device (holding tube considered to deliver girdle for approximation such that approximating is performed with holding tube 430, paras. [0045]-[0049] and [0055]; figs. 9-18).
Regarding claim 44, Douk discloses the method of claim 42. Douk further discloses wherein non-surgically approximating is performed with a second elongate medical device (420, figs. 9-18).
Regarding claim 45, Douk discloses the method of claim 44. Douk further discloses wherein non-surgically locking is performed with a third elongate medical device (440, para. [0055]).
Regarding claim 46, Douk discloses the method of claim 44. Douk further discloses wherein non-surgically locking is performed with the second elongate medical device (paras. [0055]-[0057]).
Regarding claim 56, Douk discloses the method of claim 44. Douk further discloses wherein the ventricle comprises a right ventricle (may be delivered to tricuspid valve which encompasses the right ventricle, para. [0046]), and wherein the first elongate medical device and the second elongate medical device are both inserted through a delivery lumen of an elongate delivery device (410, fig. 21).
Regarding claim 246, Douk discloses the method of claim 42. Douk further discloses wherein non-surgically locking is performed with an elongate locking device (420, para. [0055]; figs. 21-22).
Claim Rejections - 35 USC § 103
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.
Claim(s) 10, 12-13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Douk in view of Navia (US 2015/0359632 A1).
Regarding claim 10, Douk discloses the method of claim 1.
Douk further discloses wherein the ventricle comprises a left ventricle (figs. 9-18).
However, Douk fails to explicitly disclose wherein the secondary puncture comprises a puncture of a vein.
Navia teaches (paras. [0045] and [0062]; fig. 6), in the same field of endeavor, a method for treating a patient comprising accessing the left ventricle via the femoral vein (para. [0062]), in place of alternative approaches utilizing access through an artery (para. [0045]).
The substitution of one known element (approach via puncture of a vein) for another (approach via puncture of an artery, para. [0045] of Navia, para. [0046] of Douk) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of puncture of a vein as taught by Navia, would have yielded predictable results, specifically, providing access through a potentially easier access path dependent on the anatomy of the patient.
Regarding claim 12, Douk (as modified) teaches the method of claim 10. Douk (as modified) further teaches wherein delivering a distal portion of an elongate medical device into a ventricle comprises delivering the distal portion through a tertiary puncture in a septal wall between a right atrium and a left atrium (trans-septal, para. [0046] of Douk, para. [0062] and fig. 6 of Navia).
Regarding claim 13, Douk discloses the method of claim 1.
Douk further discloses wherein the ventricle comprises a right ventricle (may be delivered to tricuspid valve which encompasses the right ventricle, para. [0046]).
However, Douk fails to explicitly disclose wherein the secondary puncture comprises a puncture of a vein.
Navia teaches (paras. [0045] and [0062]; fig. 6), in the same field of endeavor, a method for treating a patient comprising accessing a ventricle via the femoral vein (para. [0062]), in place of alternative approaches utilizing access through an artery (para. [0045]).
The substitution of one known element (approach via puncture of a vein) for another (approach via puncture of an artery, para. [0045] of Navia, para. [0046] of Douk) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of puncture of a vein as taught by Navia, would have yielded predictable results, specifically, providing access through a potentially easier access path dependent on the anatomy of the patient.
Regarding claim 17, Douk discloses the method of claim 1.
Douk further discloses wherein the ventricle comprises a left ventricle (figs. 9-18).
However, Douk fails to disclose wherein the secondary puncture comprises a puncture in an apex of the heart.
Navia teaches (paras. [0045] and [0060]-[0062]; fig. 6), in the same field of endeavor, a method for treating a patient comprising accessing a ventricle via a trans-apical approach (para. [0062]), in place of alternative approaches utilizing access through an artery (para. [0045]).
The substitution of one known element (approach via puncture of an apex of the heart) for another (approach via puncture of an artery, para. [0045] of Navia, para. [0046] of Douk) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of puncture of an apex of the heart as taught by Navia, would have yielded predictable results, specifically, providing access through a potentially easier access path dependent on the anatomy of the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2018/0206992 A1 to Brown, disclosing a chordae tendineae adjustment.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/BRIGID K BYRD/Examiner, Art Unit 3771