DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a force distribution structure in claim 27.
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 § 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) 17, 18, 28, and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rolandi et al. (2015/0305739).
Rolandi discloses the following claimed limitations:
Claim 17: A medical implant (Fig. 13a, 15a, and 16-17c), that is adapted to close an opening (Fig. 18a-20), wherein the medical implant comprises at least one mechanical anchor (the microanchors seen in Fig. 13a-16, [0087], [0104], and [0122]) comprising at least one barb (Fig. 6a-d and [0104]), said anchor being adapted to puncture at least one of the patch and biological tissue (Fig. 16-17c and [0250]) such as to fix the medical implant to said tissue (Fig. 16-17c and [0250]) and is adapted to be deployed by a delivery device (where it can be deployed by a delivery device).
It has been held that the recitation that an element is "adapted to" perform a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138.
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Claim 18: comprising an adhesive composition ([0022-23] and [0247]).
Claim 28: wherein the at least one mechanical anchor comprises at least one needle ([0102], [0122], and [0157]).
Claim 29: wherein the mechanical anchor comprises an adhesive material ([0247]).
Claim(s) 17 and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ruff (5,342,376).
Ruff discloses the following claimed limitations:
Claim 17: A medical implant (2, 12, 22, 32, 42) (Fig. 1-6), that is adapted to close an opening (Fig. 11), wherein the medical implant comprises at least one mechanical anchor (6, 15, 16, 26, 27, 36, 37, 46) (Fig. 1-6) comprising at least one barb (6, 16, 26, 36, 46) (Fig. 1-6 and Col. 4 Lines 5-17) said anchor being adapted to puncture at least one of the patch and biological tissue (Fig. 11) such as to fix the medical implant to said tissue (Fig. 11) and is adapted to be deployed by a delivery device (80) (Fig. 10-11).
It has been held that the recitation that an element is "adapted to" perform a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138.
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Claim 30: A catheter device, characterized in that the catheter device (80) is adapted to deploy a medical implant according to claim 17 (Fig. 10-11) and comprises a mechanism (P) (Fig. 10-11) to apply a mechanical force to the implant and to pierce a tissue by means of a mechanical anchor (Fig. 10-11).
It has been held that the recitation that an element is "adapted to" perform a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138.
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Claim(s) 17 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sholev et al. (8,500,762).
Sholev discloses the following claimed limitations:
Claim 17: A medical implant (Fig. 3a-d), that is adapted to close an opening (Abstract), wherein the medical implant comprises at least one mechanical anchor (200) (Fig. 2a-3d, abstract, Col. 3 Lines 1-3, and Col. 4 Lines 35-55) comprising at least one barb (201) (Fig. 5g-i), said anchor being adapted to puncture at least one of the patch (2) and biological tissue such as to fix the medical implant to said tissue (Fig. 2a-3d, abstract, Col. 3 Lines 1-3, and Col. 4 Lines 35-55),and is adapted to be deployed by a delivery device (Col. 3 Lines 1-3, and Col. 4 Lines 35-55).
It has been held that the recitation that an element is "adapted to" perform a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138.
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Claim 19: wherein the at least one of the mechanical anchor and the implant comprises a magnetic element (252) adapted to connect the medical implant and the mechanical anchor at least partially via a magnetic force (Fig. 2a-3d, Col. 15 Lines 60-65, and Col. 16 Lines 60-63).
Claim(s) 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilson et al. (2012/0179176).
Wilson discloses the following claimed limitations:
Claim 31: A medical implant (300) (Fig. 3b-c), comprising an adhesive (345, 346) (Fig. 3b-c and [0096]), wherein the adhesive is arranged on at least a first surface (Fig. 3b-c) of the medical implant and formed in a pattern (Fig. 3b-c and [0096]).
Claim(s) 31-32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al. (2015/0335872).
Yang discloses the following claimed limitations:
Claim 31: A medical implant (Fig. 1a-c and 7c-d), comprising an adhesive (100, 506, [0056]) (Fig. 1a-c and 7c-d), wherein the adhesive is arranged on at least a first surface (Fig. 1a-c and 7c-d), of the medical implant and formed in a pattern (Fig. 2).
Claim 32: wherein the pattern comprises at least one spike (end of the needle as seen in Fig. 1a-2 and 7c-d).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 17, 18, 20-24, and 26-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (2015/0335872) in view of Karp et al. (2013/0331792).
Claim 17:
Yang discloses a medical implant (Fig. 7c-d), that is adapted to close an opening (Fig. 7c-d and [0102-0103]), wherein the medical implant comprises at least one mechanical anchor (506, 100) (Fig. 7c-d and [0102-0103]), said anchor being adapted to puncture at least one of the patch (502) and biological tissue such as to fix the medical implant to said tissue (Fig. 7c-d and [0102-0103]),and is adapted to be deployed by a delivery device (Fig. 7c-d where it can be deployed by a delivery device).
It has been held that the recitation that an element is "adapted to" perform a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138.
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Yang teaches all the claimed limitations discussed above, however Yang does not specify that the mechanical anchor comprises at least one barb.
Karp discloses another well-known medical device which has at least one mechanical anchor which is a needle that has at least one barb (Fig. 1-2 and [0015-16]).
It would have been obvious to one of ordinary skill in the art to modify the mechanical anchor of Yang to have at least one barb, as taught by Karp, since it has been held that a simple substitution of one known element for another will yield predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Furthermore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Yang with barbs in view of the teachings of Karp, in order to improve the grip on tissue by having more areas where the device connects to the tissue.
Yang further discloses the following claimed limitations:
Claim 18: comprising an adhesive composition (Fig. 7c-d and [0102-0103]).
Claim 20: wherein at least one mechanical anchor comprises at least one cavity ([0107] where it has a hollow lumen/cavity).
Claim 21: wherein the surface of at least one mechanical anchors comprises micro-sized holes that are connected to the at least one cavity ([0107]).
Claim 22: wherein a releasable substance is disposed in at least one cavity of at least one mechanical anchor ([0107]).
Claim 23: wherein the releasable substance comprises an adhesive composition ([0104-0107]).
Claim 24: wherein the releasable substance comprises a pharmacologically active substance ([0105-0107]).
Claim 26: wherein the mechanical anchors are adapted to reduce their size upon exposure to humidity ([0005]).
Claim 27: comprising a force distribution structure that is connected to the mechanical anchors such that it distributes a mechanical pressure applied to the medical implant among to the among the at least one mechanical anchor ([0012]).
Claim 28: wherein the at least one mechanical anchor comprises at least one needle (Fig. 7c-d and [0102-0103]).
Claim 29: wherein the mechanical anchor comprises an adhesive material (Fig. 7c-d and [0102-0103]).
Claim(s) 17, 18, 20-25, 28, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naimark et al. (2003/0073979) in view of Karp et al. (2013/0331792).
Claim 17:
Naimark discloses a medical implant (Fig. 2a-b), that is adapted to close an opening (Abstract), wherein the medical implant comprises at least one mechanical anchor (micro-needles seen in Fig. 2b and [0030] and [0057], hooks in [0030]) (Fig. 2b and [0057-58]), said anchor being adapted to puncture at least one of the patch (20) and biological tissue such as to fix the medical implant to said tissue (Fig. 2b, [0030], and [0057-58]),and is adapted to be deployed by a delivery device (Fig. 4a-b, [0005], and [0040]).
It has been held that the recitation that an element is "adapted to" perform a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138.
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Naimark teaches all the claimed limitations discussed above, however Naimark does not specify that the mechanical anchor comprises at least one barb.
Karp discloses another well-known medical device which has at least one mechanical anchor which is a needle that has at least one barb (Fig. 1-2 and [0015-16]).
It would have been obvious to one of ordinary skill in the art to modify the mechanical anchor of Naimark to have at least one barb, as taught by Karp, since it has been held that a simple substitution of one known element for another will yield predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Furthermore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Naimark with barbs in view of the teachings of Karp, in order to improve the grip on tissue by having more areas where the device connects to the tissue.
Naimark further discloses the following claimed limitations:
Claim 18: wherein the implant comprises an adhesive composition ([0030], [0037], [0046], and [0054]).
Claim 20: wherein at least one mechanical anchor comprises at least one cavity ([0059-60] and [0064]).
Claim 21: wherein the surface of at least one mechanical anchors comprises micro-sized holes that are connected to the at least one cavity ([0059-60] and [0064]).
Claim 22: wherein a releasable substance is disposed in at least one cavity of at least one mechanical anchor ([0059-60] and [0064]).
Claim 23: wherein the releasable substance comprises an adhesive composition ([0057]).
Claim 24: wherein the releasable substance comprises a pharmacologically active substance ([0068-69]).
Claim 25: wherein the medical implant comprises thrombogenic elements ([0046], [0070], and [0083]).
Claim 28: wherein the at least one mechanical anchor comprises at least one needle ([0030] and [0057]).
Claim 29: wherein the mechanical anchor comprises an adhesive material ([0030], [0037], [0046], and [0054]).
Claim 30: A catheter device, characterized in that the catheter device (150) is adapted to deploy a medical device according to claim 17 (Fig. 4a-b, [0005], and [0040]).
It has been held that the recitation that an element is "adapted to" perform a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138.
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Response to Arguments
Applicant’s arguments. filed 9/18/25, with respect to the Yang and Naimark references have been considered but are moot in view of the new grounds of rejection.
Applicant's arguments filed 9/18/25 with respect to the Sholev and Wilson references have been fully considered but they are not persuasive.
Applicant argues that Sholev does not disclose that the at least one mechanical anchor comprises at least one barb. The examiner disagrees, as seen in the rejection above, Sholev does disclose at least one mechanical anchor (200) comprising at least one barb (201) (Fig. 5g-i).
Applicant further argues that Wilson does not disclose an adhesive is arranged on at least a first surface of the medical implant since it appears to be an adhesive sandwiched between a mesh and a barrier of a prosthesis.
The examiner disagrees, the claim is reciting a medical implant that has an adhesive in a pattern on a surface of the implant, it does not differentiate a medical implant that has an adhesive between two surfaces with one that does not.
Furthermore, it appears to the examiner that Wilson teaches a medical implant (300) (Fig. 3b-c), comprising an adhesive (345, 346) (Fig. 3b-c and [0096]), wherein the adhesive is arranged on at least a first surface (Fig. 3b-c) of the medical implant and formed in a pattern (Fig. 3b-c and [0096]); hence the rejection was maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited prior art appears to teach the claimed limitations.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
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/DIANNE DORNBUSCH/ Primary Examiner, Art Unit 3771