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 Arguments
Applicant does not explicitly address the rejection of Claims 14-29 under 35 U.S.C. 112(b), however the rejection of Claims 14-29 under 35 U.S.C. 112(b) is withdrawn in view of the amendments.
Applicant’s argument on Page 5 regarding the rejection of Claim 14 under 35 U.S.C. 103 over Jackson in view of Corbitt has been fully considered but is not persuasive under new grounds of rejection as below.
Applicant’s argument on Page 5 regarding the rejection of Claim 19 under 35 U.S.C. 103 over Jackson in view of Corbitt further in view of Dyer and Al-Omishy has been fully considered but is not persuasive under new grounds of rejection as below.
Applicant’s argument on Page 6 regarding the rejection of Claim 16 under 35 U.S.C. 103 over Jackson in view of Corbitt further in view of Grinstaff has been fully considered but is not persuasive. Applicant argues that Grinstaff relates to tissue markers to mark a tissue site (e.g. a biopsy site) not for marking tissue margins after tissue removal and is not a continuous marker and cannot mark irregular shapes. However, Grinstaff is cited for teaching not the explicit use of the marker (taught by the combination of Jackson and Corbitt) but for the formation of the marker as being from polypropylene ([0109]), which one of ordinary skill in the art would understand is further applicable to marking the site following tissue removal and thereby the teachings may be used to further modify Jackson.
Applicant’s argument on Page 6 regarding the rejection of Claim 29 under 35 U.S.C. 103 over Jackson in view of Corbitt further in view of Grinstaff has been fully considered but is not persuasive. Applicant argues that Grinstaff relates to tissue markers to mark a tissue site (e.g. a biopsy site) not for marking tissue margins after tissue removal and is not a continuous marker and cannot mark irregular shapes. However, Grinstaff is cited for teaching not the explicit use of the marker (taught by the combination of Jackson and Corbitt) but for the ability to deform to forces placed on the marker while remaining fixed to the tissue that it marks ([0096] and [0109]), which one of ordinary skill in the art would understand is further applicable to marking the site following tissue removal and thereby the teachings may be used to further modify Jackson.
Regarding the rejection of all remaining corresponding claims, applicant’s argument submitted on Pages 5-6 relies on the supposed deficiencies with respect to the rejection of parent Claim 14. Applicant’s argument is moot for the same reasons detailed above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 14-15, 17, and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al. (US 20150327861) in view of Corbitt (US 20120179251) and Garcia (US 20140180065).
Regarding Claim 14, Jackson teaches a radiopaque marker, ([0001] “The present invention relates to […] radiopaque sutures […] and, more particularly to non-absorbable polyamide sutures”), comprising:
a) a non-biodegradable elongate flexible polymer (Abstract “A polyamide suture includes an elongate core […] having dispersed therein non-absorbable radiopaque nanoparticles,” [0019] “Sutures require a unique combination of physical properties. They must be nonirritating, flexible,” and [0021] “the suture of the present invention is made with Polyamide 66 (polyhexamethylene adipamide) core filaments (m.p. 255o C.) and Polyamide 6 (polycaprolactam) sheath (mp 220o C.).”); and
b) a radiopaque material disposed in the non-biodegradable elongate flexible polymer, (Abstract “A polyamide suture includes an elongate core […] having dispersed therein non-absorbable radiopaque nanoparticles”), the radiopaque material configured to make the non-biodegradable elongate flexible polymer radiopaque, ([0018] “The present invention provides a unique polyamide suture”),
c) wherein the radiopaque marker is configured to be attached to a tissue region of interest, ([0002] “According to the U.S. Pharmacopeia (USP), a nonabsorbable surgical suture is a flexible strand of material that is suitably resistant to the action of living mammalian tissue.” One of ordinary skill in the art would understand that sutures are utilized to be attached to a tissue region of interest.), and wherein the radiopaque marker is configured for non-invasive radio-imaging of the tissue region of interest, ([0001] “The present invention relates to polyamide sutures,” where one of ordinary skill in the art would understand that radiopacity relates to imaging under radiation, such as X-rays, which are non-invasive radio-imaging.), and wherein at least a portion of the radiopaque marker is configured to be disposed along a surface of the tissue of the region of interest so that the non-biodegradable elongate flexible polymer forms a continuous radiopaque marking thereby permitting the non-invasive radio-imaging of the tissue region ([0022] “When the sutures are made using core filaments of Polyamide 66 and a sheath of Polyamide 6, these sutures meet all USP specifications of average diameter and knot pull tensile strength for sutures of their size and class.”).
However, Jackson does not explicitly teach a radiopaque marker, comprising a monofilament; wherein the surface of the tissue region is located at the surface of the tissue region of interest is located at margins of the surgically removed tissue.
In an analogous tissue marking field of endeavor, Corbitt teaches a marker, comprising a monofilament ([0024] “implant 2 […] in which outer shell 4 includes […] monofilament propylene fibers”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Jackson with the monofilament structure of Corbitt as monofilament structures bypass tissue more easily than multi-filament structures. Moreover, monofilament suture-like structures are not novel in the art, see Dyer.
In an analogous fiduciary marker and respective placement field of endeavor, Garcia teaches a radiopaque marker, ([0020] “As used herein, the term "marker" will refer to a radio-opaque fiduciary marker that is placed within the body in a specific location to mark the location of a feature, for example a tumor site or the boundaries of an organ or tissue.”), wherein the surface of the tissue region is located at the surface of the tissue region of interest is located at margins of the surgically removed tissue (Fig. 4, [0017] “The tumor resection bed (403) is an area where cancerous bladder mucosa tissue was previously removed. Markers (404) are placed within the bladder mucosa layer at a short distance from the margin of the tumor resection bed,” and [0039] “the markers placed into the target area by […] suturing,” where one of ordinary skill in the art would understand that “suturing the markers” may allow for suturing the radiopaque markers, as described above, into the tissue in order to denote a boundary following tissue removal, as described in Garcia.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the marker and its respective placement of Garcia because it may help an operator direct therapeutic radiation more precisely to a target area as they are designed to avoid movement, as taught by Garcia in [0008], following tissue removal, in order to minimizing likelihood of disease returning.
Regarding Claim 15, the modified marker of Jackson teaches all limitations of Claim 14, as discussed above. Furthermore, Jackson teaches wherein at least a portion of the radiopaque marker is configured to be knotted (It is understood by one of ordinary skill in the art that sutures, as taught by Jackson, are configured to be knotted, as in [0019] “Sutures require a unique combination of physical properties. They must be nonirritating, flexible and exhibit high tensile strength and knot strength.”).
Regarding Claim 17, the modified marker of Jackson teaches all limitations of Claim 14, as discussed above. Furthermore, Jackson teaches wherein the non-biodegradable elongate flexible polymer monofilament has a circular cross-section (as shown in Fig. 1, reproduced below, where the individual filaments 14 and the suture 10 have circular cross-sections).
Regarding Claim 25, the modified marker of Jackson teaches all limitations of Claim 14, as discussed above. Furthermore, Corbitt teaches a dye or colorant disposed in the non-biodegradable elongate flexible polymer monofilament, the dye or colorant configured to enhance visibility of the radiopaque marker while disposed in the tissue region of interest ([0042] “The breast implant preferably includes a permanent or temporary dye marker such as, but not limited to, indigo carmine or methylene blue.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Corbitt by including a dye or colorant because the modification allows for so that in the future an operating surgeon can identify the surrounding tissue before he violates the previously biopsied cavity, as taught by Corbitt in [0042].
Regarding Claim 26, the modified marker of Jackson teaches all limitations of Claim 14, as discussed above. Furthermore, Jackson teaches a suture needle coupled to the non-biodegradable elongate flexible polymer monofilament (Claim 12 “a […] suture […], attached to a needle.”).
Regarding Claim 27, the modified marker of Jackson teaches all limitations of Claim 14, as discussed above. Furthermore, Jackson teaches wherein the radiopaque marker is configured to be sutured to the tissue ([0002] “According to the U.S. Pharmacopeia (USP), a nonabsorbable surgical suture is a flexible strand of material that is suitably resistance to the action of living mammalian tissue” and [0004] “increased likelihood of tissue inflammation,” where one of ordinary skill in the art can conclude that the suture of Jackson is configured to be sutured to tissue).
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Fig. 1 of Jackson
Claims 16 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al. (US 20150327861) in view of Corbitt (US 20120179251) and Garcia (US 20140180065), as applied to Claim 14 above, and further in view of Grinstaff et al. (US 20150297316).
Regarding Claim 16, the modified marker of Jackson teaches all limitations of Claim 14, as discussed above. However, the modified marker of Jackson does not explicitly teach wherein the non- biodegradable elongate flexible polymer monofilament is formed from polypropylene.
In an analogous tissue marker field of endeavor, Grinstaff teaches a radiopaque marker, ([0115] “at least one material forming the flexible polymer matrix can include a radiopaque polymer”), wherein the non-biodegradable, ([0107] “the polymer material forming the flexible polymer matrix can be […] non-biodegradable.”), elongate flexible polymer monofilament, ([0059] “The shape-memory alloy material and/or elastic material can be provided in any shape, e.g., but not limited to, straight or curved wire, ribbon, […] or any combinations thereof.”), is formed from polypropylene ([0109] “examples of degradation-resistant polymeric materials suitable for use in the flexible polymer matrix can include […] polypropylene”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Grinstaff because polypropylene is relatively inexpensive, has a low coefficient of friction, making it ideal for insertion into the body, is very resistant to moisture, and has good chemical resistance over a wide range of bases and acids.
Regarding Claim 29, the modified marker of Jackson teaches all limitations of Claim 14, as discussed above. Furthermore, Grinstaff teaches wherein at least a portion of the radiopaque marker is able to deform to forces placed upon it by the surrounding tissue, while remaining fixed in its location with respect to the tissue that it marks ([0096] “As used herein, the term “flexible” generally refers to a material being capable of bending or flexing such that it is pliant and yieldable in response to a change in surrounding condition (e.g., an applied force), without causing any macroscopic breaking. A flexible material can generally alter geometric shape and/or geometric structure to accommodate a change in surrounding condition and to conform or adjust to the shape of an object brought in contact with it without losing its integrity” and [0109] “a non-biodegradable material can stay in vivo for a significantly long amount of time, or even permanently.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Grinstaff because the modification is the desired outcome of placing a marker, a user does not want the marker to shift or break and then shift, so the modification being able to deform slightly to offset the forces placed upon it is most beneficial.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al. (US 20150327861) in view of Corbitt (US 20120179251) and Garcia (US 20140180065), as applied to Claim 17 above, and further in view of Rizk et al. (US 20160045636).
Regarding Claim 18, the modified marker of Jackson teaches all limitations of Claim 17, as discussed above. However, the modified marker of Jackson does not explicitly teach wherein the circular cross-section has a diameter from 300 microns to 400 microns.
In analogous self-retaining suture field of endeavor, Rizk teaches a radiopaque marker, ([0083] “It may also be advantageous to incorporate contrast agents, radiopaque markers, imaging agents, or radioactive substances into the P4HB polymer and copolymers thereof prior to spinning fibers suitable for making high tensile strength self-retaining sutures.”), wherein the circular cross-section has a diameter from 300 microns to 400 microns ([0045] “The diameters of the monofilament fibers of P4HB and copolymers thereof may range from 0.05 mm to 1 mm, but are more preferably 0.07 mm to 0.799 mm,” which is between 50 microns to 1000 microns and 70 microns to 799, where the claimed cross-section diameter of 300 microns to 400 microns will fall between the range of the diameter of Rizk).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Rizk by having the circular cross-section have a diameter from 300 microns to 400 microns because such a range of the diameter does not compromise on important features of the suture, such as tensile strength, while also keeping the insertion size of the suture as small as possible as taught by Rizk in [0005]-[0006].
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al. (US 20150327861) in view of Corbitt (US 20120179251) and Garcia (US 20140180065), as applied to Claim 14 above, and further in view of Dyer et al. (US 4639253) and Al-Omishy (“X-ray detectable thread for orientating […]”).
Regarding Claim 19, the modified marker of Jackson teaches all limitations of Claim 14, as discussed above. However, the modified marker of Jackson does not explicitly teach wherein the radiopaque material comprises barium sulfate.
In an analogous x-ray detectable element field of endeavor, Dyer teaches a radiopaque marker, (Abstract “A surgical sponge constructed of a nonwoven fabric is provided with an integral x-ray detectable element”), wherein the radiopaque material comprises barium sulfate (Claim 4 “said X-ray detectable element is a monofilament comprising a thermoplastic polymeric material containing about 60% barium sulfate.” Where the monofilament may be removed and utilized to mark the tissue, see Al-Omishy.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Dyer because the combination ensures that the marker will be visible under the imaging modality.
Regarding Claim 20, the modified marker of Jackson teaches all limitations of Claim 19, as discussed above. Furthermore, Dyer teaches wherein the barium sulfate has a weight of 40% or more of a total weight of the radiopaque marker (Claim 4 “said X-ray detectable element is a monofilament comprising a thermoplastic polymeric material containing about 60% barium sulfate.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Dyer by including barium sulfate at a weight of 40% or more of total weight of the marker because the modification ensures that the marker will be visible under the imaging modality without noticeably affecting the physical structure of the marker.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al. (US 20150327861) in view of Corbitt (US 20120179251) and Garcia (US 20140180065), as applied to Claim 14 above, and further in view of Eidenschink et al. (US 20080021313).
Regarding Claim 21, the modified marker of Jackson teaches all limitations of Claim 14, as discussed above. However, the modified marker of Jackson does not explicitly teach wherein the non-biodegradable radiopaque marker has a tensile strength of greater than 20 N.
In an analogous radiopaque marker field of endeavor, Eidenschink teaches a radiopaque marker, ([0070] “radiopaque marker 10”), wherein the non-biodegradable radiopaque marker has a tensile strength of greater than 20 N ([0073] “Marker 10 may have tensile strength of between 20 MPa and 160 MPa.” Where 1 MPa is equal to 1x106 Newtons (per m2)).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Eidenschink by having the marker have a tensile strength greater than 20 N because having a high tensile strength ensures the marker will not break, snap, move, or become dislocated in a way not desired.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al. (US 20150327861) in view of Corbitt (US 20120179251) and Garcia (US 20140180065), as applied to Claim 14 above, and further in view of Russell (US 20060072706).
Regarding Claim 22, the modified marker of Jackson teaches all limitations of Claim 14, as discussed above. However, the modified marker of Jackson does not explicitly teach wherein the radiopaque marker is configured to be visible under radiographic imaging performed at 20 kV.
In an analogous marker for radiographic examination field of endeavor, Russell teaches a radiopaque marker, (Abstract “The present invention provides a partially radiolucent, partially radiopaque marker and a method for using such a marker for radiographic examination.”), wherein the radiopaque marker is configured to be visible under radiographic imaging performed at 20 kV ([0038] “Markers of this type are useful in imaging soft tissue at a radiation energy ranging from about 20 KV to about 40 KV,” where the claimed performance of radiographic imaging at 20 kV will fall between the range of Russell).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Russell because such an imaging range is typically used for imaging procedures around mammography, and used in less dense tissues of a patient, as taught by Russell in [0035] and [0038].
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al. (US 20150327861) in view of Corbitt (US 20120179251) and Garcia (US 20140180065), as applied to Claim 14 above, and further in view of Nath (WO 2017106474).
Regarding Claim 23, the modified marker of Jackson teaches all limitations of Claim 14, as discussed above. However, the modified marker of Jackson does not explicitly teach wherein a portion of the non-biodegradable elongate flexible polymer monofilament comprises a knot having a tensile strength of 20 N.
In an analogous flexible filament field of endeavor, Nath teaches wherein a portion of the non-biodegradable elongate flexible polymer monofilament, ([0006] “a synthetic suture is used, such as a monofilament polypropylene”), comprises a knot having a tensile strength of 20 N ([0006] “The knot-pull strength, in kilograms, of a suture string in this example may be from 0.09 kg to 5.23 kg,” which is between 0.88 N and 51.29 N, where the claimed tensile strength of 20 N will fall between the range of the knot pull strength of Nath).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Nath by having a knot having a tensile strength of 20 N because this ensures that the marker will not break or move undesirably under stress, which if such occurred would defeat the purpose of remaining as a permanent marker.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al. (US 20150327861) in view of Corbitt (US 20120179251) and Garcia (US 20140180065) and Nath (WO 2017106474), as applied to Claim 23 above, and further in view of Grinstaff et al. (US 20150297316).
Regarding Claim 24, the modified marker of Jackson teaches all limitations of Claim 23, as discussed above. Furthermore, Nath teaches a knot ([0006] “For example, a slack suture is preferred for tying knots, if knotting is required.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Nath because the knot allows for a secure placement for the marker on the tissue region of interest and prevents the suture or marker from migrating.
However, the modified marker of Jackson does not explicitly teach securing the radiopaque marker to the tissue to prevent movement thereof.
In an analogous tissue marker field of endeavor, Grinstaff teaches securing the radiopaque marker to the tissue to prevent movement thereof ([0061] “the tissue marker is implanted into a tissue at a target tissue site without the use of an adhesive.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Grinstaff because securing the marker to one spot allows a clinician to return to the spot at a later point in time for re-examination or treatment planning, as taught by Grinstaff in [0003].
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al. (US 20150327861) in view of Corbitt (US 20120179251) and Garcia (US 20140180065) and, as applied to Claim 14 above, and further in view of Silver et al. (“Knot Security – How is […]”).
Regarding Claim 28, the modified marker of Jackson teaches all limitations of Claim 14, as discussed above. Furthermore, Jackson teaches wherein at least a portion of the radiopaque marker is configured to be knotted with multiple suture knot throws (It is understood by one of ordinary skill in the art that sutures, as taught by Jackson, are configured to be knotted, as in [0019] “Sutures require a unique combination of physical properties. They must be nonirritating, flexible and exhibit high tensile strength and knot strength.” Additionally, it is further understood by one of ordinary skill in the art that multiple suture knot throws are standard in the art for security of suture, see Silver NPL.).
Conclusion
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 MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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