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 .
Response to Amendment
Applicants inclusion of Figs. 9A-C and 10 and the amended specification filed 10/18/2024 are sufficient to overcome the drawing objection of claims 1, 3, 12, and 13. Therefore, the drawing objections are withdrawn. However, another drawing objection is applied for Figs. 9A-C due to the shading of the figures (see explanation below).
Applicant’s amendments to claims 1-7, 9-13, and 15-16 to overcome the previous 112(b) rejections are acknowledged. However, the claims are still rejected under 112(b) for other issues (see below).
Response to Amendment
Applicant's arguments filed 10/18/2024 have been fully considered but they are not persuasive.
Applicant argued that Rafiee fails to disclose “wherein each DGF member comprises a head portion configured to be embedded in tissue”. Applicant explains that the Rafiee anchor 4910 is formed from compliant foldable material that is intended to be deployed after positioning the tether 4920 through a puncture in the valve commissure such that the anchor 4910 may be positioned against the commissure without damaging the tissue.
The examiner respectfully disagrees. The limitation “configured to be embedded in tissue” is interpreted as functional language, therefore the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the head portion of each DGF member is capable of doing. For example, Rafiee discloses the structural component i.e. the head portion (interpreted as a first end having the anchor 4910 disposed thereon, para. 0229; see annotated Fig. 49[a] below). During insertion of the head portion of the DGF member, the reference discloses “the tether 4920 is withdrawn from the sheath 4820, and passes through the annulus until the anchor 4910 is urged against the ventricular side of the mitral annulus”. Therefore, the proximal portion of the head portion must extend through an opening of the mitral annulus, and is thereby embedded in the mitral annulus, to allow the distal end of the head portion to abut against the mitral annulus. The examiner further notes that the claim language is very broad and could also be interpreted as the head portion being embedded in the heart (a type of tissue) since the entire DGF member is positioned inside a patient. Since, the device of Rafiee meets the structural limitation of the claim, the device of Rafiee also meets the functional limitation. The rejection of claim 1 is maintained.
Applicant argues that Rafiee fails to disclose “the at least locking member is configured to pass through one of the plurality of through holes in the prosthetic valve in one direction only to fix the stent between the at least one locking member and the body portion”. Applicant explains that these locks/crimps 4940 are not used to secure the prosthesis, but, instead, are used to secure the tether 4920, to allow the prosthesis to be advanced over the tether 4920. Further, the Rafiee clips/locks 4940 are incapable of working in this manner. As clearly shown, the clips/locks 4940 have blunt proximal ends and tapered distal ends. Thus, these clips/locks 4940 would prevent passage through through-holes of a stent of the prosthesis given these blunt proximal ends and, even if the clips/locks 4940 could somehow be forced through a through-hole, the tapered distal ends would allow the stent to migrate proximally.
The examiner respectfully disagrees. The examiner notes that the claims are directed towards an apparatus, not a method. The limitation “configured to pass through one of the plurality of through-holes in the prosthetic valve in one direction only to fix the stent between the at least one locking member and the body portion” is interpreted as functional language and defines the intended use of the device, therefore the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the at least one locking member is capable of doing. For example, Rafiee discloses the structural component i.e. the at least one locking member 4940 (Fig. 49, para. 0233-0234) designed to lock the tethers. However, locking the tethers in place allows for the stent to be guided along the tethers to then be secured at the target site. Para. 0243 discloses “Once the prosthesis is in its final position, the prosthesis can be locked in place permanently. Clips or locks can be used, moreover, the conduits 5710 can be deformable and can be crushed over rails/tethers 4920, 5020 to lock the prosthesis 5700 in place and tethers removed in FIG. 60A for a full prosthesis and FIG. 60B for a partial prosthesis.”. Furthermore, Figs. 63C-E, para. 0250 of Rafiee discloses that the at least one locking member 4940 is capable of passing through one of the plurality of through-holes (interpreted as holes within loops 5702) in the prosthetic valve in one direction only to fix (which does not mean to permanently fix, but can include interpretations such as attaching, or securing) the stent between the at least one locking member 4940 and a portion of the body portion (see annotated Fig. 49 below in the rejection for the interpreted body portion).
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since, the device of Rafiee meets the structural limitation of the claim, the device of Rafiee also meets the functional limitation.
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Annotated Fig. 49[a] of Rafiee
Drawings
The drawings are objected to because in Figures 9A-C, the use of shading in the drawings fails to aid in understanding of the invention and it reduces legibility. Spaced lines for shading are preferred. These lines must be thin, as few in number as practicable, and they must contrast with the rest of the drawings. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. See 37 CFR 1.84 (m) and (I).
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-3, 6, 17, and 21 are objected to because of the following informalities:
Claim 1, line 26: “prosthetic valve” which should recite “the prosthetic valve”.
Claim 2, line 1: “each head portion is” which should recite “each of the head portions are”, since the head portions were previously recited in claim 1. This objection is maintained for other limitations such as “each DGF member further comprises” in line 3 which should recite “each of the DGF members further comprise”.
Claim 3, lines 1 and 2: “each body portion is” which should recite “each of the body portions are”, since the head portions were previously recited in claim 1.
Claim 4, line 3: “the at least locking member” which should recite “the at least one locking member”.
Claim 6, line 19: “prosthetic valve” which should recite “the prosthetic valve”.
Claim 17, line 1: “each head portion is” which should recite “each of the head portions are”, since the head portions were previously recited in claim 1.
Claim 21, line 1: “each locking member comprises” which should recite “each of the locking members comprise”, since the locking members were previously recited in claim 19.
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:
“a fixation mechanism” in claim 1. The limitation introducing the fixation mechanism in claim 1 fails to include sufficient structure to perform the recited function of “fixation". In the specifications, the fixation mechanism includes a plurality of DGF locking members (see para. 25 of the instant application) Therefore, the limitation will be interpreted as the plurality of DGF locking members.
“a plurality of engagement structures designed to engage” in claim 3. The plurality of engagement structures in claim 3 are “designed to engage with the DGF delivery system” (functional) and “comprises a plurality of passages” (structural). The limitation describing the plurality of engagement structures in claim 3 fails to include sufficient structure to perform the recited function of “engaging". In the specifications, para. 0101 recites “the DGF member 101 is configured with…a body portion 103 with an engager 109 that engages a DGF delivery catheter”. Therefore, the limitation will be interpreted as any structure that is capable of or designed to "engage" a DGF delivery catheter comprising a plurality of passages.
“a mechanism” in claim 9. The mechanism in claim 9 is used to attach the valve chamber to a valve chamber sheath such that the position of the valve chamber is controllable by operating the valve chamber sheath on the proximal side of the VHPL system.” (functional). The limitation describing the mechanism in claim 9 fails to include sufficient structure to perform the recited function of “attaching”. Furthermore, the specifications fails to include any mention of a mechanism for attaching the valve chamber to the valve chamber sheath. Therefore, the limitation will be interpreted as any structure that is capable of or designed to "attach" the valve chamber to the valve chamber sheath.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 19 recites “wherein the stent comprises an upper flared portion including the plurality of through-holes, and wherein each DGF member comprises a locking member spaced apart from the body portion such that the upper flared portion fits snugly between the locking member and body portion in the operative position”. Para. 99 of the written description of the instant application introduces the locking member 105 and body member 103 (which appears to be the claimed body portion) and para. 108 of written description further states that the body member 103 comprises the locking member. This is supported by Figure 2A which illustrates the locking member 105 being a part of the body portion. The written description, nor the drawings, of the instant application supports “a locking member spaced apart from the body portion” as claimed. Therefore, claim 19 and dependent claims 20-21 are rejected under 112(a).
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 1-21 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.
Claim 1 recites “a prosthetic valve” in line 4. It is unclear to the examiner if “a prosthetic valve” in line 4 is an additional valve included in the system or further defining the prosthetic heart valve recited in the preamble. The examiner notes that if applicant wants to positively recite the prosthetic valve in the body of the claims, the preamble must be amended. For examination purposes, “a prosthetic valve” in line 4 is further defining the prosthetic heart valve in the preamble.
Claim 1 recites “a plurality of DGF members” in line 10. It is unclear to the examiner if “a plurality of DGF members” in line 10 are additional members included in the system or further defining the plurality of DGF members introduced in line 6. For examination purposes, “a plurality of DGF members” in line 10 is further defining the plurality of DGF members introduced in line 6.
Claim 1 recites “a prosthetic valve” in line 11. It is unclear to the examiner if “a prosthetic valve” in line 11 is an additional valve included in the system or further defining the prosthetic valve recited in the preamble. The examiner notes that if applicant wants to positively recite the prosthetic valve in the body of the claims, the preamble must be amended. For examination purposes, “a prosthetic valve” in line 11 is further defining the prosthetic heart valve in the preamble.
Claim 4 recites “wherein the fixation mechanism comprises at least one locking member and at least one tether; wherein the at least one tether is configured to attach the at least one locking member to the body portion and the at least locking member is configured to pass through one of the plurality of through-hole in the prosthetic valve in one direction only to fix the stent between the at least one locking member and the body portion”. Para. 99 of the written description of the instant application introduces the locking member 105 and body member 103 (which appears to be the claimed body portion) and para. 108 of written description further states that the body member 103 comprises the locking member. This is supported by Figure 2A which illustrates the locking member 105 being a part of the body portion. It is unclear to the examiner how the stent can be positioned “between” the locking member and the body portion if the locking member is a part of the body portion. Therefore, claim 4 and dependent claim 5 are rejected under 112(b) for lack of clarity. For examination purposes, the limitation is interpreted as “between the at least one locking member and a portion of the body portion”.
Claim 6 recites “a prosthetic valve” in line 4. It is unclear to the examiner if “a prosthetic valve” in line 4 is an additional valve included in the system or further defining the prosthetic heart valve recited in the preamble. The examiner notes that if applicant wants to positively recite the prosthetic valve in the body of the claims, the preamble must be amended. For examination purposes, “a prosthetic valve” in line 4 is further defining the prosthetic heart valve in the preamble.
Claim 6 recites “a prosthetic valve” in line 10. It is unclear to the examiner if “a prosthetic valve” in line 10 is an additional valve included in the system or further defining the prosthetic valve recited in the preamble. The examiner notes that if applicant wants to positively recite the prosthetic valve in the body of the claims, the preamble must be amended. For examination purposes, “a prosthetic valve” in line 10 is further defining the prosthetic heart valve in the preamble.
Claim 6 recites “a plurality of DGF members” in line 11. It is unclear to the examiner if “a plurality of DGF members” in line 11 are additional members included in the system or further defining the plurality of DGF members introduced in line 9. For examination purposes, “a plurality of DGF members” in line 11 is further defining the plurality of DGF members introduced in line 9.
Claim 6 recites “a tail portion” in line 28. It is unclear to the examiner if “a tail portion” in line 28 is an additional tail portion in the system or is meant to further define the tail portion introduced in line 14. For examination purposes, “a tail portion” in line 28 is further defining the tail portion introduced in line 14.
Claim 9 recites “tissue” in line 3. It is unclear to the examiner if “tissue” is an additional tissue operated on or is further defining the tissue introduced in line 13 of claim 1. For examination purposes, “tissue” of claim 9 is further defining the tissue introduced in line 13 of claim 1.
Claim 19 recites “wherein the stent comprises an upper flared portion including the plurality of through-holes, and wherein each DGF member comprises a locking member spaced apart from the body portion such that the upper flared portion fits snugly between the locking member and body portion in the operative position”. Para. 99 of the written description of the instant application introduces the locking member 105 and body member 103 (which appears to be the claimed body portion) and para. 108 of written description further states that the body member 103 comprises the locking member. This is supported by Figure 2A which illustrates the locking member 105 being a part of the body portion. It is unclear to the examiner how the locking member can be “spaced apart” from the body portion if the locking member is a part of the body portion. Therefore, claim 19 and dependent claims 20-21 are rejected under 112(b) for lack of clarity.
Claim 21 recites the limitation "the at least one locking member " in line 4. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, "the at least one locking member " is interpreted as “the locking member”.
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.
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) 1, 4, 8, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Rafiee (US 20140018906) in view of Dale et al. (US 20140371844) [hereinafter Dale].
Regarding claim 1, Rafiee discloses a heart valve leaflet replacement delivery system for implanting a prosthetic heart valve for treatment of a diseased heart valve within a patient’s body (Figs. 57A, 63A-E, para. 0242, 0248-0250), the system comprising:
a prosthetic valve 5700 comprising a stent (interpreted as the frame of the prosthesis 5700) (Fig. 57A, para. 0242), the stent comprising a plurality of through-holes (interpreted as the holes defined by loops 5702) (Fig. 57A, para. 0242);
a plurality of dual-guiding and fixation (DGF) members 4910 (Figs. 63A-B, para. 0229, 0248)
a multi-stage, multi-lumen (MSML) delivery system, comprising a dual-guiding-and- fixation (DGF) delivery system (interpreted as the leaflet active fixation system shown in Fig. 63A, para. 0248) and a valve housing, positioning, and locking (VHPL) system (interpreted as the delivery system shown in Fig. 63C, para. 0250) configured cooperatively for advancing to an operative position (interpreted as the position when the prosthetic valve is placed within a target site, Figs. 63C-E, para. 0250), and for delivering and implanting a plurality of DGF members (interpreted as 4910, see 112b rejection above) to the operative position (Figs. 63A-B, para. 0229, 0248), and for guiding, delivering, and fixing a prosthetic valve to the operative position (Figs. 63A-E, para. 0248-0250);
wherein each DGF member 4910 comprises a head portion (interpreted as a first end having the anchor 4910 disposed thereon, para. 0229; see annotated Fig. 49 below) configured to be embedded in tissue (see note below), a body portion (interpreted as portion having a plurality of locks/crimps 4940 disposed thereon, see annotated Fig. 49 below, para. 0229) including a fixation mechanism (interpreted as the plurality of locks/crimps 4940 and mating ratcheting teeth disposed on the tether such that "the ratchet engagement maintains the position of the lock", para. 0229, 0234, see 112f interpretation above), and a tail portion 4920 that extends from the body portion comprising a tether (Fig. 49, para. 0229);
Note: “configured to be embedded in tissue” is interpreted as functional language, therefore the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the head portion of each DGF member is capable of doing. For example, Rafiee discloses the structural component (interpreted as a first end having the anchor 4910 disposed thereon, para. 0229; see annotated Fig. 49 below). During insertion of the head portion of the DGF member, the reference discloses “the tether 4920 is withdrawn from the sheath 4820, and passes through the annulus until the anchor 4910 is urged against the ventricular side of the mitral annulus”. Therefore, the proximal portion of the head portion that must extend through an opening of the mitral annulus to allow the distal end of the head portion to abut against the tissue is embedded into the tissue. The examiner further notes that the claim language is very broad and could also be interpreted as the head portion being embedded in the heart (a type of tissue) since the entire DGF member is positioned inside a patient. Since, the device of Rafiee meets the structural limitation of the claim, the device of Rafiee also meets the functional limitation.
the DGF delivery system (interpreted as the leaflet active fixation system shown in Fig. 63A, para. 0248) configured to implant the plurality of DGF members (interpreted as 4910) in the native annulus such that one end of each tail portion 4920 is attached to the respective body portion (interpreted as portion having a plurality of locks/crimps 4940 disposed thereon, see annotated Fig. 49 below, para. 0229) and the other end of each tail portion exits the patient’s body to aid in guiding and fixing the prosthetic valve (see note below), the tail portions 4920 extending from the body portion to the proximal side of the DGF delivery system to guide prosthetic valve delivery via the plurality of through-holes (interpreted as the holes defined by loops 5702) (Figs. 57A, 58B, para. 0242-0243); and
Note: “the other end of each tail portion exits the patient’s body to aid in guiding and fixing the prosthetic valve” is interpreted as functional language and defines the intended use of the device, therefore the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the tail portion of each DGF member is capable of doing. For example, Rafiee discloses the structural component i.e. the tail portion 4920 of each of the DGF member (Fig. 49, para. 0229). Para. 0231 discloses a proximal end 4950 of the tail portion 4920 is “the proximal end 4950 of guide 4900 is withdrawn into the introducer sheath 4820 of delivery device 4800…At this point, locks/crimps 4940 can be advanced to the atrial side of the annulus and secured in place, resulting in the tethers 4920 being directed through the mitral valve and out of the heart to act as placement guides for a prosthesis.”. Therefore, if the user withdraws the introducer sheath of the delivery device such that it exits the patient’s body, the proximal end of the tail portions are also capable of exiting the patient’s body as well. The examiner notes that Rafiee suggests that the other end of the tail portions are not required to be positioned in the heart to guide the prosthetic valve to its target site. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since, the device of Rafiee meets the structural limitation of the claim, the device of Rafiee also meets the functional limitation.
the VHPL system (interpreted as the delivery system shown in Fig. 63C, para. 0250) configured to track over the tail portions 4920 to a desired implantation location at the previously implanted DGF members, and incrementally release the prosthetic valve from a crimped state (Figs. 63C-D, para. 0250), and fix the prosthetic valve to the DGF members via the fixation mechanism (Para. 0242 discloses that the through holes (interpreted as holes within loops 5702) serve as the conduit for passage of the tethers/rails. Para. 0243 discloses that clips/locks can be used to permanently lock the prosthetic valve in place and para. 0250 discloses that the VHPL system is used to deliver the prosthetic valve, wherein once the prosthetic valve is delivered to the target site, the valve is locked in place.).
Rafiee further discloses the use of the prosthetic valve for replacing a mitral valve (para. 0086, 0242). However, Rafiee fails to disclose the prosthetic valve comprising at least one prosthetic leaflet.
Dale in the same field of endeavor teaches a prosthetic valve 300 used for replacing a mitral valve 130 (Figs. 1-3, para. 0041) comprising a stent 350 and at least one prosthetic leaflet 362 within the stent 350 (Fig. 3A, para. 0043) for the purpose of replacing the function of native mitral valve leaflets (para. 0043).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the prosthetic valve in Rafiee to include the at least one prosthetic leaflets of Dale in order to act as a one-way valve within the native mitral valve to prevent backflow of blood into the left atrium (para. 0040, 0043), thereby increasing the functionality of the prosthetic valve and since Dale specifically teaches that it is known in the art to include prosthetic leaflets within the prosthetic valve for a mitral valve replacement procedure (para. 0040).
Rafiee discloses an alternative VHPL delivery system in Fig. 70 comprising a proximal sheath/backend mechanism portion of the delivery system and a distal sheath/tip mechanism portion of the delivery system (Figs. 69-70, para. 0258-0259). However, Rafiee fails to disclose how the two-part delivery system works and fails to disclose incrementally release the prosthetic valve from a crimped state starting with a proximal-most portion of prosthetic valve and moving to a distal-most portion of the prosthetic valve.
Dale in the same field of endeavor teaches a two-part delivery system 1200 (Figs. 11A-G, para. 0065, 0069, 0071-0077) comprising a delivery sheath 1240 having a distal first segment 1242 and a proximal second segment 1244 (Figs. 11A-G, para. 0069, 0071-0077), wherein the delivery sheath 1200 is configured to incrementally release a prosthetic valve from a crimped state starting with a proximal-most portion 850 of prosthetic valve and moving to a distal-most portion 872 of the prosthetic valve (Figs. 11A-I, para. 0071-0077).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to substitute the two-part delivery VHPL system in Dale for the VHPL system, since such a modification is a substitution of one prosthetic valve delivery system for another and would yield the predictable result of sequentially delivering the prosthetic valve to the target site (Figs. 11A-I, para. 0071-0077); KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
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Annotated Fig. 49 of Rafiee
Regarding claim 4, Modified Rafiee discloses wherein the fixation mechanism comprises at least one locking member 4940 and at least one tether (interpreted as the portion of the tether with mating ratcheting teeth such that "the ratchet engagement maintains the position of the lock", para. 0234 of Rafiee); wherein the at least one tether is configured to attach the at least one locking member to the body portion (annotated Fig. 49 above, para. 0234 of Rafiee) and the at least locking member 4940 is configured to pass through one of the plurality of through-holes (interpreted as holes within loops 5702) in the prosthetic valve (Fig. 57A, para. 0242 of Rafiee) in one direction only to fix the stent between the at least one locking member and the body portion (see note below).
Note: “configured to pass through one of the plurality of through-holes in the prosthetic valve in one direction only to fix the stent between the at least one locking member and the body portion” is interpreted as functional language and defines the intended use of the device, therefore the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the at least one locking member is capable of doing. For example, Rafiee discloses the structural component i.e. the at least one locking member 4940 (Fig. 49, para. 0233-0234) designed to lock the tethers and thereby the stent in place. Para. 0243 discloses “Once the prosthesis is in its final position, the prosthesis can be locked in place permanently. Clips or locks can be used, moreover, the conduits 5710 can be deformable and can be crushed over rails/tethers 4920, 5020 to lock the prosthesis 5700 in place and tethers removed in FIG. 60A for a full prosthesis and FIG. 60B for a partial prosthesis.”. Furthermore, Figs. 63C-E, para. 0250 of Rafiee discloses that the at least one locking member 4940 is capable of passing through one of the plurality of through-holes (interpreted as holes within loops 5702) in the prosthetic valve in one direction only to fix (which does not mean to permanently fix, but can include interpretations such as attaching, or securing) the stent between the at least one locking member 4940 and a portion of the body portion (see annotated Fig. 49 above for the interpreted body portion; see 112b rejection above). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since, the device of Rafiee meets the structural limitation of the claim, the device of Rafiee also meets the functional limitation.
Regarding claim 8, Modified Rafiee discloses wherein the crimped prosthetic valve is housed within a valve chamber 1240 at a distal end of the VHPL system 1200 in a crimped delivery condition (Figs. 11A-C, para. 0071-0075 of Dale).
Regarding claim 14, Modified Rafiee discloses all of the limitations set forth above in claim 1. However, Modified Rafiee fails to disclose wherein the prosthetic valve stent is configured with at least one elongated member extending between about two and six millimeters (2-6 mm) from a lower flared portion of the stent, and wherein the lower flared portion can be configured to be straight or curved inward radially.
Dale further discloses wherein the prosthetic valve stent 810 is configured with at least one elongated member (interpreted as struts of stent 850) comprising retainers 890 extending from a lower flared portion 880 of the stent 810 (Figs. 11H-I, para. 0077-0078), and wherein the lower flared portion 1880 can be configured to be curved inward radially (Fig. 11I, para. 0071) for the purpose attaching to a retaining element 1260 of the VHPL system (Figs. 11H-I, para. 0077-0078).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the prosthetic valve stent in Modified Rafiee to include the at least one elongated member comprising retainers 890 of Dale and to modify the VHPL system in Modified Rafiee to include the retaining element 1260 in order to prevent an unintentional deployment of the prosthetic valve from the second segment 1244 of the valve chamber 1240 (para. 0077).
Regarding the dimensions of the at least one elongated member, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one elongated member of Modified Rafiee to extend between about two and six millimeters (2-6 mm) from the lower flared portion of the stent, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
In the instant case, the device of Modified Rafiee would not operate differently with the claimed length since the at least one elongated member of Modified Rafiee is intended to mate with the retaining element (Figs. 11H-I, para. 0077-0078 of Dale), having the claimed length, the device would function appropriately. Further, it appears that applicant places no criticality on the length claimed, indicating simply that “the extending member 7 is about two to seven millimeters (2-7 mm) longer than the other parts of the stent 3” (see para. 84 of the instant application).
Regarding claim 15, Modified Rafiee discloses wherein the at least one elongated member 850 is configured to selectively engage the VHPL system via. retainers 890 such that the prosthetic valve can be guided, expanded, and fixed in position at the plurality of DGF members before selectively detaching the prosthetic valve from the VHPL system (Fig. 11A-11I. para. 0077-0078 of Dale).
Claim(s) 2 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Rafiee (US 20140018906) in view of Dale et al. (US 20140371844) [hereinafter Dale], as applied to claim 1 above, and further in view of Rothe et al. (US 20050251162) [hereinafter Rothe].
Regarding claim 2, Modified Rafiee discloses all of the limitations set forth above in claim 1. Rafiee further discloses a spiral anchor in the embodiment of Fig. 67A (para. 0257), as an alternative anchor shape. However, Modified Rafiee fails to disclose wherein each head portion is configured with a spiral with a length of between 4 - 10 mm, and a diameter of between 2 to 5 mm, formed with wire with a diameter between 0.25 - 1.0 mm, and wherein each DGF member further comprises a stabilization member configured as a straight wire with a diameter between 0.25 - 1.0 mm extending axially through a center of the spiral with a sharpened tip extending between 1-3 mm beyond an end of the spiral.
Rothe in the same field of endeavor teaches a tissue grasper (see Figs. 2A-B, 4D, para. 0126, 0149) comprising a head portion (interpreted as helix 90) configured with a spiral (Fig. 4D, para. 0149) formed with wire (para. 0147 discloses that a tissue acquisition member 28 may be a wire which has the tissue grasper integrally formed at its distal end, wherein the helix of the tissue grasper may be integrally formed by winding or coiling the distal portion of the tissue grasper in a helix configuration. Therefore, the head portion i.e. helix is formed with wire) and a stabilization member (interpreted as needle 92) configured as a straight wire (Fig. 4D, para. 0149) extending axially through a center of the spiral 90 with a sharpened tip (Fig. 4D, para. 0149).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to substitute the helical and stabilization anchor in Rothe for the anchor in Modified Rafiee, since such a modification is a substitution of one anchor for another and would yield the predictable result of providing the device with an anchor that pierces the tissue via. the stabilization member before initial entry of the helix (para. 0149); KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding the dimensions of the head portion and the stabilization member, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the head portion of Modified Rafiee to have the spiral with a length between 4 - 10 mm, and a diameter between 2 to 5 mm, formed with the wire with a diameter between 0.25 - 1.0 mm and the stabilization member of Modified Rafiee to have a straight wire with a diameter between 0.25 - 1.0 mm with the sharpened tip extending between 1-3 mm beyond the end of the spiral, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
In the instant case, the device of Modified Rafiee would not operate differently with the claimed lengths and diameters and since the anchor of Modified Rafiee is intended to pierce and anchor within tissue (Figs. 2A-B, para. 0149), having the claimed lengths and diameters, the device would function appropriately. Further, it appears that applicant places no criticality on the lengths and diameters claimed, indicating simply that “the DGF head member 102 is configured with a coil 108 with a length between about four and ten millimeters (4-10 mm), and a diameter between about two and five millimeters (2-5 mm), formed with wire with a diameter between 0.25 and one millimeter (0.25-1.0 mm)” (see para. 103 of the instant application) and “In one exemplary aspect, the stabilization member 111 is configured as a straight wire with a diameter between about 0.25 and one millimeter (0.25-1.0 mm) extending axially through the center of the spiral with a sharpened tip extending between about one and three millimeters (1-3 mm) beyond the end of the spiral” (see para. 104 of the instant application).
Regarding claim 18, Modified Rafiee discloses all of the limitations set forth above in claim 1. However, modified Rafiee fails to disclose wherein the head portion of each DGF member comprises one of a spiral shape, a coil shape, a pronged shape, a screw shape, and a barbed hook shape configured to screw the head portion into tissue adjacent the annulus.
Rothe in the same field of endeavor teaches a tissue grasper (see Figs. 2A-B, 4D, para. 0126, 0149) comprising a head portion (interpreted as helix 90) comprising a spiral configured to screw the head portion into tissue (Fig. 4D, para. 0149).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to substitute the spiral head portion in Rothe for the head portion in modified Rafiee, since such a modification is a substitution of one anchor for another and would yield the predictable result of providing the device with an anchor that pierces the tissue (para. 0149); KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim(s) 3 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Rafiee (US 20140018906) in view of Dale et al. (US 20140371844) [hereinafter Dale], as applied to claim 1 above, and further in view of Gross et al. (US 20110166649 ) [hereinafter Gross].
Regarding claim 3, Modified Rafiee discloses all of the limitations set forth above in claim 1. Rafiee further discloses wherein each body portion is configured to attach to the respective head portion and resist separation (see annotated Fig. 49 above, para. 0229). However, Modified Rafiee fails to disclose each body portion is configured with a plurality of engagement structures (see 112b interpretation above) designed to engage with the DGF delivery system, and comprises a plurality of passages, wherein at least one passage of the plurality of passages is configured for securing the fixation mechanism to the body portion, and at least one passage of the plurality of passages is for attaching a stabilization member.
Gross in the same field of endeavor teaches a helical tissue anchor 360 comprising a body portion 380 configured with a plurality of engagement structures 380 (the “plurality” is interpreted as a plurality of tissue anchors 360, each having an engagement structure 380, Figs. 1 and 4, para. 0263 of Gross; see 112b rejection above) designed to engage with a DGF delivery system (Fig. 4, para. 0263) and comprises a plurality of passages 390 (Fig. 4, para. 0263), wherein at least one passage of the plurality of passages is configured for securing a fixation mechanism to the body portion, and at least one passage of the plurality passages is for attaching a stabilization member (see note below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the DGF members in Modified Rafiee to include the helical tissue anchor comprising the plurality of engagement structures of Gross in order to provide the anchor with a structure to efficiently attach the anchors to the DGF delivery system to corkscrew the anchor into the tissue (para. 0263).
Note: “whe