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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “reference boundary” and the “at least one thread which projects at regular intervals from said reference boundary into the interior volume of said braid” must be shown or the feature(s) canceled from the claim(s). 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 – 5, 7, 8, 10 – 15, 19, and 20 are objected to because of the following informalities:
Claim 1 recites “wherein it comprises” (line 2), “a hollow braid configured to receive in its interior volume” (line 3), and “comprising over its length a central repair part arranged between first and second lateral parts along a length of the hollow braid” (line 4), although the lines are understood by the Examiner to mean “wherein the implantable device comprises”, “a hollow braid with an interior volume configured to receive”, and “comprising a central repair part arranged between first and second lateral parts along a length of the hollow braid”, respectively, the Examiner suggests the lines be amended to remove the words “it” and “its” and to read something along the lines of “wherein the implantable device”, “a hollow braid with an interior volume configured to receive”, and “comprising a central repair part arranged between first and second lateral parts along a length of the hollow braid”, respectively, for the purpose of maintaining consistent language throughout the claims;
Claim 1 recites “the braiding angle” in lines 5, 6, and 7, although the lines are understood to mean “a braiding angle” as the “braiding angle” for each part was not previously defined, the Examiner suggests the lines be amended to read “a braiding angle” for the purpose of having antecedent basis for the claimed terms;
Claim 1 recites “and/or smaller” in line 7, however this is not grammatically correct, thus the Examiner suggests the line be amended to read “and/or is smaller”;
Claims 1 (line 6), 2 (line 3), 4 (line 4), 5 (line 3), 12 (line 3), 13 (lines 2, 4, and 6), 14 (line 2), 20 (line 2) recite “the central part”, although the lines are understood by the Examiner to mean “the central repair part” as previously defined and further repeated in later dependent claims, the Examiner suggests each instance of “the central part” be amended to read “the central repair part” for the purpose of maintaining consistent language throughout the claims;
Claims 2 (line 2), 4 (line 2), 7 (lines 2 and 5), claim 10 (line 2), claim 11 (line 2) recite “the braid”, although the lines are understood by the Examiner to mean “the hollow braid” as previously defined and repeated in later dependent claims, the Examiner suggests each instance of “the braid” be amended to read “the hollow braid” for the purpose of maintaining consistent language throughout the claims;
Claims 3 (lines 2 and 4) and 15 (line 2) recite “said region”, although the lines are understood by the Examiner to mean “said at least one region” as previously defined, the Examiner suggests each instance of “said region” be amended to read “said at least one region” for the purpose of maintaining consistent language throughout the claims;
Claim 3 recites “the number of stitches per inch” in line 3, although the line is understood by the Examiner to mean “a number of stitches per inch” as the “number of stitches per inch” of the said at least one region of the first lateral part was not previously defined, the Examiner suggests the line be amended to read “a number of stitches per inch” for the purpose of having proper antecedent basis for the claimed terms;
Claim 5 recites “its diameter at rest” in line 4, although the line is understood by the Examiner to mean “a diameter of the central repair part at rest”, the Examiner suggests the line be amended to take out the word “its” and for the line to be amended to read “a diameter of the central repair part at rest” for the purpose of having proper antecedent basis for the claimed terms;
Claim 7 recites “wherein it comprises” in line 3, although the line is understood by the Examiner to mean “wherein the hollow braid comprises”, the Examiner suggests the line be amended to remove the word “it” and to amend the line to read “wherein the hollow braid comprises” for the purpose of maintaining consistent language throughout the claims;
Claim 8 recites “at least one of the strands” in line 2, although the line is understood by the Examiner to mean “at least one of the one or more braided strands” as previously defined, the Examiner suggests the line be amended to read “at least one of the one or more braided strands” for the purpose of maintaining consistent language throughout the claims;
Claims 11 and 19 recite “at least one of the filaments of which has a count” in lines 3 – 4, although the lines are understood by the Examiner to mean “at least one of the at least four filaments has a count” as previously defined, the Examiner suggests the lines be amended to read “at least one of the at least four filaments has a count” for the purpose of maintaining consistent language throughout the claims and for the purpose of proper grammar;
Claim 13 recites “its length at rest” and “elongates to reach a length” in line 3, although the line is understood by the Examiner to mean “a length of the central repair part at rest”, the Examiner suggests the line be amended to read “a length of the central repair part at rest” for the purpose of maintaining consistent language throughout the claims;
Claim 14 recites “the length of the central part” and “the length of the first lateral part” in lines 2 and 3, although the lines are understood by the Examiner to mean “a length of the central repair part” and “a length of the first lateral part” as neither lengths were previously defined, the Examiner suggest the lines be amended to read “a length of the central repair part” and “a length of the first lateral part” for the purpose of maintaining consistent language throughout the claims;
Claim 15 recites “less than or equal to, 1.2 times the number”, however this is not grammatically correct, therefore the Examiner suggests the line be amended to read “less than or equal to 1.2 times the number”;
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 13, and 15 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 3, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of Examination, the claim will be given the broadest reasonable interpretation and, thus, the phrase after “preferably” will not be examined. However, if Applicant is intending for the language after “preferably” to be included in the claim, the Examiner notes that claim 15 would not be further limiting the subject matter of claim 3 (see the first 112(d) rejection of claim 15 below).
Regarding claim 13, the phrase ”the central part elongates to a length smaller than or equal to the length at rest of the central part” renders the claim indefinite because it is unclear how the central part can “elongate” to a length smaller than or equal to the length of the central part at rest because “to elongate” the central part means to make the central part longer and if the central part is elongated (i.e., made longer) than the length of the central part cannot be “smaller” or “equal to” the length of the central part when at rest (i.e., not elongated).
Regarding claim 15, the phrase "the number of stitches per inch is less than or equal to 1.2 times the number of stitches in said region of the first lateral part" renders the claim indefinite because it is unclear what region Applicant is intending for “the number of stitches per inch”, that are less than equal to 1.2 times the number of stitches in said region of the first lateral part, to be in; moreover, it is unclear if said region is the central repair region or the second lateral region. For the purpose of examination, based on Applicant’s disclosure, the Examiner will read the claim such that the number of stitches per inch in the central repair region is less than or equal to 1.2 times the number of stitches in said region of the first lateral part. Furthermore, with the Examiner’s interpretation above, Claim 15 is further rejected under 112(d). See the second 112(d) rejection of claim 15.
Claim 15 is also rejected for being dependent on an indefinite claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 recites, not under the Examiner’s interpretation, “the central repair part comprises a number of stitches per inch less than, less than or equal to, 1.2 times the number of stitches per inch in said region of the first lateral part” and Claim 15 recites, under the Examiner’s interpretation, “the number of stitches per inch of the central repair part is less than or equal to 1.2 times the number of stitches per inch in said region of the first lateral part”; because both claims 3 and 15 require the number of the stitches per inch of the center part to be in the same range, claim 15 does not further limit the subject matter of claim 3. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 recites, under the Examiner’s interpretation, “the central repair part comprises a number of stitches per inch less than 1.2 times the number of stitches per inch in said region of the first lateral part” and Claim 15 recites, under the Examiner’s interpretation, “the number of stitches per inch of the central repair part is less than or equal to 1.2 times the number of stitches per inch in said region of the first lateral part”; the “or equal to” language broadens the range of the number of stitches that the central repair part comprises. Therefore, Claim 15, under the Examiner’s interpretation, does not further limit claim 3. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(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.
Claims 1 – 3, 10, 14, 15, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yodfat (US 2004/0199243 A1).
Regarding claim 1, Yodfat discloses an implantable device (implantable blood filtering device 20) capable of repairing at least one tendon or ligament (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88. With that said the device of Yodfat is structurally similar to the claimed device and therefore is capable of functioning in the manner claimed) (abstract, paragraphs [0063 – 0064], [0163 – 0164] and Fig. 7), wherein the implantable device comprises:
a hollow braid (mesh-like element 102) (paragraphs [0073 – 0074], [0163], and Fig. 7) configured to receive in its interior volume at least one portion of a tendon or ligament (Examiner’s note: the term “tubular” is defined as a cylindrical hollow structure; and as stated in paragraphs [0063] and [0073] the implantable device / mesh-like element is a tubular structure, thus the mesh-like element 102 is considered to be hollow. Furthermore, because the mesh-like element 102 is hollow it is capable of functioning to receive at least one portion of a tendon or a ligament as claimed), and comprising over its length a central repair part (region L”F – Fig. 7) arranged between first and second lateral parts (regions L”2 and L”1, respectively, – Fig. 7), in that the braiding angle (angle αf”) in at least one region of the central part (region L”F ) at rest (configuration shown in Fig. 7; i.e., configuration when not compressed) is smaller than the braiding angle (angle α2”) in at least one region of the first lateral part (region L”2) at rest (configuration shown in Fig. 7) (paragraph [0171] and Fig. 7).
Regarding claims 2, 3, and 15, Yodfat discloses wherein the braid (mesh-like element 102) comprises a number of stitches per inch which is gradually decreasing from said at least one region of the first lateral part (region L”2) towards said at least one region of the central part (region L”F) and wherein said region of the central repair part (region L”F) comprises a number of stitches per inch which is less than 1.2 times the number of stitches per inch in said region of the first lateral part (region L”2) (Examiner’s note: Applicant’s disclosure defines “stitches” as the number of wire crossings, and as shown in Fig. 7, the number of wire crossings gradually decreases from the region L”2 (i.e., the first lateral part) to the region L”F (i.e., the central part), and as shown in Fig. 7 the number of wire crossings in the region L”F (i.e., the central part) is less than 1.2 times the number of wire crossings in the region L”2 (i.e., the first lateral part)).
Regarding claims 10 and 18, Yodfat discloses wherein the braid (mesh-like element 102) comprises at least one monofilament thread (filaments 24) having a diameter less than or equal to 350 pm, and greater than or equal to 50 pm (60 µm – paragraph [0104]).
Regarding claim 14, Yodfat discloses wherein the length of the central part (region L”F) is greater than or equal to the length of the first lateral part (region L”2) (Fig. 7).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 6, 10, 12, 14, 15, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Zilla et al (US 2007/0293932 A1) and in view of Wilson et al (US 2008/0082165 A1).
Regarding claim 1, Zilla discloses an implantable device (tubular support 77) (abstract, paragraphs [0097 – 0098] and Figs. 5 – 6) capable of repairing at least one tendon or ligament (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88. With that said the device of Zilla is structurally similar to the claimed device and therefore is capable of functioning in the manner claimed), wherein the implantable device comprises:
a hollow braid (tubular support 77) (paragraphs [0097 – 0098] and Figs. 5 – 6) configured to receive in its interior volume at least one portion of a tendon or ligament (Examiner’s note: it should be understood that the preceding limitation is an intended use limitation which requires only that the structure of the prior art is capable of functioning in the manner claimed. With that said, as shown in Fig. 5 and discussed in paragraph [0098] the device is hollow and configured to be coaxial about a tubular tissue segment, thus the device of Zilla is capable of functioning as claimed), and comprising a central repair part arranged between first and second lateral parts (see annotated Figs. 5 and 6).
However, Zilla is silent regarding (i) wherein the braiding angle of the central part is smaller than the braiding angle in the first and/or the second region parts at rest. With respect to the above, it should be understood that Zilla teaches wherein when the ends of the hollow braid are pushed closer together, the central portion of the hollow braid expands to a diameter greater than the diameter of the central portion of the hollow braid when at rest.
As to the above, Wilson teaches an expandable mesh device (braided Nitinol tube – shown in Figs. 1 and 2) (paragraph [0044]) comprising a braid with a central part (deformable mesh region 102; which equates to the central repair part of Zilla) and first and second lateral parts (proximal and distal ends 106 and 104; which equate to the first and second lateral parts of Zilla) wherein the central part has a braid angle less than that of the first and second lateral parts in the rest state (Examiner’s note: as stated in paragraph [0044] the maximum diameter (i.e., the diameter when expanded) can be increased by decreasing the braid angle of the tube, and thus it is desirable to decrease the braid angle in the central portion, when at rest, of the braided Nitinol tube for the purpose of increasing the maximum diameter of the central portion of the braided Nitinol tube when in the expanded state).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the designated central region of the tubular support of Zilla to have a smaller braid angle, based on the teachings of Wilson, for the purpose of increasing the maximum diameter of the expandable mesh element when in the expanded state which allows for larger diameter vessels to be supported therein.
Annotated Figures 5 and 6 of Zilla
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Regarding claim 2, as discussed above, it would be obvious to modify the central region of the tubular support to comprise a smaller braid angle than the braid angle of the lateral regions based on the teachings of Wilson. The combination further makes obvious wherein the braid (tubular support 77 – Zilla) comprises a number of stitches per inch which is gradually decreasing from said at least one region of the first lateral part towards said at least one region of the central part (Examiner’s note: Applicant’s Specification, paragraph [0065], defines the number of stitches per inch as the crossing between two braided strands; and in order to decrease the braid angle of the central portion in the modified device, the number of stitches must be decreased in the central portion as the modification did not modify the number of filaments that make up the tubular support 77. Therefore, the combination encompasses the central region having less stitches per inch than the lateral regions because the central region has a lower braid angle. Additionally, it has been held that choosing any solution from a finite number of solutions to obtain a predictable result is well within the purview of ordinary skill in the art. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S., 82 USPQ2d 1385 (2007). It can be seen that there are only a finite number of solutions for transitioning the number of stitches from the lateral regions to the central repair region, the transitioning of the number of stitches can be either: stepped or gradual. Therefore, it would have been obvious to one of ordinary skill in the art to modify decrease the number stitches from the first lateral part to the central part to be gradual since there are a limited number of possible ways to transition said number and having the transition be gradual would have yielded, with a reasonable expectation of success, the tubular mesh being able to expand as intended. Moreover, “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product is not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. 103.” KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007). Therefore, it would have been obvious to try having the transition of the number of stitches from the first lateral part to the central part be gradual. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rationale E, outlined in MPEP 2143.
Regarding claims 3 and 15, as discussed above, it would be obvious to modify the central region of the tubular support to comprise a smaller braid angle than the braid angle of the lateral regions based on the teachings of Wilson. Additionally, the combination further teaches wherein said region of the central repair part (see annotated Fig. 5 and 6 of Zilla) comprises a number of stitches per inch which is less than the number of stitches in said region of the first lateral part (Examiner’s note: Applicant’s Specification, paragraph [0065], defines the number of stitches per inch as the crossing between two braided strands; and in order to decrease the braid angle of the central portion in the modified device, the number of stitches must be decreased in the central portion as the modification did not modify the number of filaments that make up the tubular support 77. Therefore, the combination encompasses the central region having less stitches per inch than the lateral regions).
However, the combination is silent regarding (i) the number of stitches in the central region being less than 1.2 times the number of stitches per inch in said region of the first lateral part.
As to the above, there is no evidence of record that establishes that changing the number of stitches of the central region to be less than or equal to 1.2 times the number of stitches would result in a difference in function of the Zilla device. Further, a person having ordinary skill in the art, being faced with modifying the number of stitches of the Zilla device would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed relative number of stitches compared to that of the first lateral region. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the amount of stitches of the central region “may” be within the claimed range, and offering other acceptable ranges (e.g., the central part having 1 to 15 stiches per inch and the first lateral part having 10 to 20 stiches, specification at paras. [0066 – 0067]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, 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 number of stitches of the central region be less than 1.2 times the number of the stitches in the first lateral region as an obvious matter of design choice within the skill of the art.
Regarding claim 4, as discussed above, it would be obvious to modify the central region of the tubular support to comprise a smaller braid angle than the braid angle of the lateral regions based on the teachings of Wilson. Additionally, the combination teaches wherein the braid (tubular support 77 – Zilla) is structurally configured so that, under the effect of a determined internal deformation, the rate of radial expansion of the first or second lateral part is smaller than the rate of radial expansion of the central part (Examiner’s note: the modification above was such that the central region of the tubular support 77 of Zilla has a lower braid angle than that in the lateral regions; and in order to obtain a decreased braid angle, the number of stitches / crossing strands in the central region must be reduced, since no additional strands were added. Therefore, the lateral regions have a higher number of stitches / crossing strands; moreover, the number of stitches / crossing strands is directly correlated to the amount of expansion resistance, such that the more stitches / crossing strands a region has the higher the expansion resistance of said region will be. Therefore, because the lateral regions have a higher number of stitches / crossing strands than the central region, the rate of radial expansion of the lateral regions will be less than the rate of expansion of the central region).
Annotated Figures 5 and 6 of Zilla
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Regarding claim 5, as discussed above, the combination of Zilla and Wilson teaches the device of claim 1. Additionally, Zilla discloses wherein under the effect of a determined internal deformation, the central part (see annotated Figs. 5 and 6 of Zilla) has an expanded diameter greater (diameter in Fig. 5) than its diameter at rest (diameter in Fig. 6).
However, the combination is silent regarding (i) wherein the expanded diameter is greater than or equal to 1.5 times the rest diameter.
As to the above, there is no evidence of record that establishes that changing expanded diameter to be within the range of greater than or equal to 1.5 times the rest diameter would result in a difference in function of the Zilla device. Further, a person having ordinary skill in the art, being faced with modifying expanded diameter to rest diameter ratio of the Zilla device would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed relative number of stitches compared to that of the first lateral region. Lastly, Applicant has not disclosed that the claimed range solves any stated problem, indicating that expanded diameter of the central part “in one variant” may be within the claimed range (specification at para. [0075]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, 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 expanded diameter to be within the range of greater than or equal to 1.5 times the rest diameter as an obvious matter of design choice within the skill of the art.
Regarding claim 6, as discussed above, the combination of Zilla and Willson teaches the device of claim 1 above. Additionally, Zilla discloses the first lateral part has a diameter at rest D1 (diameter of the lateral regions, designated in annotated Fig. 6), and is structurally configured to have an expanded diameter under the effect of a determined internal deformation, with less than or equal to 1.5 times D1 (Examiner’s note: it should be understood that the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning in the manner claimed. With that said, the first lateral part of Zilla is capable of having an expanded diameter of less than or equal to 1.5 times the diameter at rest).
Regarding claims 10 and 18, as discussed above, the combination of Zilla and Willson teaches the device of claim 1 above. Additionally, Zilla discloses wherein the braid (tubular support 77 – Zilla) comprises at least one monofilament thread having a diameter less than or equal to 350 µm and greater than or equal to 50 µm (paragraph [0099]).
Regarding claim 12, as discussed above, it would be obvious to modify the central region of the tubular support to comprise a smaller braid angle than the braid angle of the lateral regions based on the teachings of Wilson. Additionally, the combination teaches wherein the hollow braid (tubular support 77 – Zilla) has a longitudinal axis L, and in that wherein the central part has an elongation, in the longitudinal direction L under a given load, greater than the elongation of the first lateral part under said load and in said longitudinal direction (Examiner’s note: because the tubular support 77 (i.e., the hollow braid) is modified to have a smaller braid angle in the central portion when at rest, the central portion will have smaller resistance to compression, therefore, under a given load, the central part will elongate more than the first lateral part under the same load. Therefore, the combination encompasses the limitations above).
Regarding claims 14 and 20, as discussed above, the combination of Zilla and Willson teaches the device of claim 1 above. Additionally, Zilla discloses wherein the length of the central part (see annotated Figs. 5 and 6) is greater than or equal to, particularly by at least 1.5 times, the length of the first lateral part (see annotated Figs. 5 and 6) (Examiner’s note: as shown in the annotated Figs. 5 and 6, in both the rest and the expanded state, the length of the central part is greater than at least 1.5 times the length of the first lateral part).
Claims 7, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Zilla et al (US 2007/0293932 A1) in view of Wilson et al (US 2008/0082165 A1), as applied to claim 1, and further in view of Kurland (US 4,400,833).
Regarding claims 7, 16, and 17, as discussed above, the combination of Zilla and Wilson teaches the device of claim 1 above. Additionally, Zilla discloses wherein the braid (tubular support 77) comprises an inner surface with a reference boundary (Examiner’s note: as shown in Fig. 5 the tubular support is hollow and thus has an inner surface with a reference boundary (i.e., a cross-sectional boundary)).
However, the combination is silent regarding (i) wherein the braid comprises at least one monofilament thread which projects at regular intervals from said reference boundary into the interior volume of said braid, wherein said at least one thread forms regions in relief.
As to the above, Kurland teaches, in the same field of endeavor, an implantable device (layer of mesh-backed pericardium 18) comprising a hollow braid (mesh-backed pericardium 18) configured to receive in its volume at least one portion of a tendon (tendon 10) for the purpose of adding extra means of securing the implant to the tissue (col. 3 lines 47 – 61), wherein the braid comprises at least one monofilament thread (stitches 24) (Examiner’s note: the stitches 24 are either multifilament threads or a monofilament thread; either configuration the stitch comprises at least one thread, wherein the thread is a monofilament thread because the multifilament threads are comprised of individual monofilament threads) wherein said at least one thread forms regions in relief (Examiner’s note: Applicant’s disclosure defines regions in relief as “evenly distributed regions”, and as shown in Fig. the stiches are evenly distributed along the length, thereby creating evenly distributed regions of relief as defined by Applicant).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Zilla in view of Wilson to incorporate the inwardly extending threads, based on the teachings of Kurland, for the purpose of strengthening the connection between the implant and the connected tissue.
Claims 8, 9, 11, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Zilla et al (US 2007/0293932 A1) in view of Wilson et al (US 2008/0082165 A1), as applied to claim 1, and further in view of Thompson (US 6,019,786) and Silvestrini et al (US 4,834,755).
Regarding claims 8 and 9, as discussed above, the combination of Zilla and Wilson teaches the device of claim 1 above.
However, the combination is silent regarding (i) wherein the braid comprises at least one monofilament and at least one multifilament arranged in a substantially parallel manner.
As to the above, Thompson teaches an implantable hollow prosthesis comprising a flexible tubular interbraided structure (prosthesis 18; which equates to the tubular support 77 of Zilla) comprising at least one monofilament strand (structural strands 32) (col 5. Lines 28 – 32) and at least one multifilament (textile strands 42) (col. 7 lines 12 – 25 and Fig. 4), wherein the at least one monofilament and the at least one multifilament are arranged in a substantially parallel manner (Fig. 4). Furthermore, Thompson teaches the use of monofilaments and multifilament threads allows for the hollow braid to maintain its nominal shape and enhance the utility and resilience of the graft (abstract).
Additionally, Silvestrini teaches, in the same field of endeavor, an implantable device (ligament prosthesis 1) comprising a hollow braid (prosthesis 1) configured to receive in its interior volume at least on portion of a ligament (col. 2 line 24 – col. 3 line 10 and Fig. 1) wherein the braid comprises at least one monofilament (fibers 9) (col. 9 lines 12 – 15) and at least one multifilament (fibers 11/13) (col. 9 lines 16 – 23), for the purpose of providing the prosthesis with a combination of higher elasticity and yield strength and resistance to longitudinal deformation (col. 4 lines 4 – 54). Therefore, Silvestrini teaches forming a hollow braided sleeve / conduit for surrounding a tissue / ligament comprising monofilaments and multifilament threads.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the braiding of the device of Zilla in view of Wilson to incorporate monofilaments and multifilament threads, based on the teachings of Thompson and Silvestrini, for the purpose of providing the braiding the ability to maintain its nominal shape and to enhance the utility and resilience of the graft (abstract – Thompson).
Regarding claims 11 and 19, as discussed above, the combination of Zilla and Wilson teaches the device of claim 1 above.
However, the combination is silent regarding (i) wherein the braid comprises at least one multifilament thread, (ii) wherein the at least one multifilament comprising at least four filaments, and (iii) wherein at least one of the filaments of which has a count less than or equal to 10 dtex.
As to (i) – (ii), Thompson teaches an implantable hollow prosthesis comprising a flexible tubular interbraided structure (prosthesis 18; which equates to the tubular support 77 of Zilla) comprising at least one monofilament strand (structural strands 32) (col 5. Lines 28 – 32) and at least one multifilament (textile strands 42) (col. 7 lines 12 – 25 and Fig. 4), wherein the multifilament thread comprises more than four filaments (col. 12 line 49 and Fig. 17) (Examiner’s note: as shown in Fig. 17, the multifilament thread comprises more than 4 filaments). Additionally, Thompson teaches the use of monofilaments and multifilament threads allows for the hollow braid to maintain its nominal shape and enhance the utility and resilience of the graft (abstract).
Additionally, Silvestrini teaches, in the same field of endeavor, an implantable device (ligament prosthesis 1) comprising a hollow braid (prosthesis 1) configured to receive in its interior volume at least on portion of a ligament (col. 2 line 24 – col. 3 line 10 and Fig. 1) wherein the braid comprises at least one monofilament (fibers 9) (col. 9 lines 12 – 15) and at least one multifilament (fibers 11/13) (col. 9 lines 16 – 23), for the purpose of providing the prosthesis with a combination of higher elasticity and yield strength and resistance to longitudinal deformation (col. 4 lines 4 – 54). Therefore, Silvestrini teaches forming a hollow braided sleeve / conduit for surrounding a tissue / ligament comprising monofilaments and multifilament threads.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the braiding of the device of Zilla in view of Wilson to incorporate monofilaments and multifilament threads, based on the teachings of Thompson and Silvestrini, for the purpose of providing the braiding the ability to maintain its nominal shape and to enhance the utility and resilience of the graft (abstract – Thompson).
As to (iii), there is no evidence of record that establishes that changing the count of at least one of the four filaments of the multifilament thread to be less than or equal to 10 dtex would result in a difference in function of the Zilla device. Further, a person having ordinary skill in the art, being faced with modifying count of at least one of the four filaments of the multifilament thread device would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed count(s). Lastly, Applicant has not disclosed that the claimed range solves any stated problem, indicating that the number of counts “may” be within the claimed range and offering other acceptable ranges (e.g. greater than or equal to 1dtex and less than or equal to 30dtex, specification at paras. [0055]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify count of at least one of the at least four filaments of the at least one multifilament to be less than 10dtex as an obvious matter of design choice within the skill of the art.
Examiner’s note
Claim 13 as currently written is not rejected under prior art because the prior art of record alone or in combination with fails to teach or disclose the device of claim 1 in combination with wherein the braid elongates to a smaller length than its un-elongated length. However, Claim 13 is rejected under 112(b) for being indefinite, see the above 112(b) section for more details.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Janardhan et al (US 10,390,926 B2), Dickinson et al (US 10,835,367 B2), Düring et al (US 2017/0304093 A1), Peterson et al (US 2012/0239145 A1), and McFarland Jr. (US 3,613,120) each teach an implantable mesh with multiple regions having varying braid angles.
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/Andrew Restaino/Primary Examiner, Art Unit 3771