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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/22/25 has been entered.
Response to Arguments
Applicant's arguments filed 10/22/25 have been fully considered but they are not persuasive. Applicant argues the arcuate support elements of Ketai do not curve outward away from the first plane in opposite directions. However, the examiner disagrees because the support elements on the planar hoop of Ketai originate from opposite sides of the hoop and extend in opposite directions to one another thus these extend in opposite directions. With respect to the Glicksman and Mongrain rejection, the arguments are not persuasive as the claims are ambiguous to what is required by the use of two opposite transition clauses, consisting and comprising. Therefore, Glickman is highly relevant to the claimed invention as it is an oncoplastic device with framework similar to the claims and Mongrain clearly teaches free end arcuate support structures. Applicant is reminded obviousness rejections are combinations of teachings and the prior art must be considered in its entirety. Further the prior art teaching of radiographic elements is well known and obvious over the numerous references cited and of record.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The new limitation of “the two arcuate support elements extending from opposite sides of the single ovoid base element…..in a direction transverse to the longitudinal axis of the single ovoid base element” recited in claim 2 is not supported by the written disclosure and is new matter. It is not understood how “arcuate support elements” can be transverse to the longitudinal axis of the single “ovoid base element” when an arc is curved and extends out or away from a line that would extend perpendicular to the axis of the base element. A portion of the arcuate support element may pass through a point to be transverse to the base element, but in no way can an arc be considered transverse to a base element. Also the new limitation of “the arcuate support elements lying in a second plane that is perpendicular to the first plane” recited in claim 14 is not supported by the written disclosure and is new matter. It is not seen how the “arcuate support elements” can lie in a plane perpendicular to the first plane of the “planar hoop” when an arc is curved and extends out the plane. A portion of the arcuate support element may pass through a plane perpendicular to the planar hoop, but in no way can an arc be perpendicular to another plane. Further Applicant fails to detail where this is explained. Dependent claims carry the indefinite issue of its independent claim.
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 2-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. In claim 2, the use of two different transitional clauses in the claim presents conflicting scope issues. For example in line 2 of the claim the term “comprising” is used which is an open ended recitation that suggests other elements, features and arrangements are permissible. However, then in line 3 of the claim it presents a narrow term “consisting” that suggests only features recited are defining an apparatus. Thus, the claim (2) and its dependents are indefinite because it is not clear what the boundaries of the claim are as to what is permitted to be part of the device and what cannot. In claim 14, the use of two different transitional clauses in the claim presents conflicting scope issues. For example in line 2 of the claim the term “consisting” is used which is a closed ended recitation that suggests the claim is limited to that which is recited. However, then in line 4 of the claim it presents an open-ended term “comprising” that suggests additional features not recited are not necessarily excluded from the scope of the claim. Thus, the claim (14) and its dependents are indefinite because it is not clear what the boundaries of the claim are as to what is permitted to be part of the device and what cannot.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 14,17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ketai et al. (2013/0282059). Please note the intended use of “placement within a surgically created cavity” carries no weight in the absence of any distinguishing structure. In this instance the limitation is essentially unlimited in scope as it sets forth no locations, dimensions or even how it is placed, but more importantly is a use or method type step not necessarily required in a product claim when the device is fully capable of performing the function. Fig. 10 shows an implantable device consisting of: an open framework body formed by a plurality of framework elements, the plurality of framework elements comprising: a planar hoop defining a base with an open center, and two arcuate support elements 910 (note this feature is broad and undefined as to what exactly defines a “support element’) extending respectively from opposite sides of the planar hoop, the arcuate support elements being cantilevered over the open center of the base to provide the open framework body with a three-dimensional profile. Please note as best understood the arcuate support elements extend from opposite sides and thus are curving out from the plane in opposite directions. It can be construed that the arcuate support elements have a portion that lie in a plane perpendicular to the plane of the planar hoop. Regarding claim 17, since the claimed device is disclosed by the prior art with the same structure, it can be construed it is capable of providing structural support to tissue forming the surgically- created cavity and to allow seroma fluid to pass through the open framework body so that, after placement of the oncoplastic device within the surgically -created cavity, the seroma fluid can promote tissue regrowth within the open framework body to at least partially reconstruct a breast. With respect to claim 18, Ketai et al. also disclose (paragraph 116) that the arcuate support elements are configured to provide compliance or compressibility to the open framework body to be supportive to tissue. Regarding claim 19, it can also be understood the open framework body has a flattened or low profile shape as seen in Fig. 10 and is fully capable of being with this configuration in placement of a surgically-created cavity, especially since “low-profile” is relative terminology. With respect to claim 20, as seen in Fig. 10 it can be understood that the device if placed in a surgically created cavity, a height of the open framework is less than a width and a length of the open framework body.
Claim(s) 2-9,11 are rejected under 35 U.S.C. 103 as being unpatentable over Glicksman (WO 2007/000756) in view of Mongrain et al. (2007/0276465) and Conklin (2013/0166022). Glicksman shows (Figs. 19A,B) an oncoplastic device 350 for placement within a surgically-created cavity, the oncoplastic device comprising: a three-dimensional support structure consisting of a single ovoid element 354 defining an open center and two arcuate support elements projecting from the single ovoid element. None of the other support features of the 3D support structure have this shape. Please note a change in shape only involves routine skill in the art and if one does not consider the surrounding band as not “ovoid” it would have been obvious to one of ordinary skill in the art to modify and form as an ovoid to provide a suitable non-penetrating form via an entire circumferential profile being arcuate in form. Thus, less trauma is provided as sharp corners or edges are removed via an “ovoid” profile. However, Glicksman did not disclose at least one of the two or more arcuate support elements has a free, unsupported end. Mongrain et al. teach (Figs. 2,3) that an open framework for surgical implantation utilizes arcuate support elements which are cantilevered (free ends) over the open center to define a three dimensional profile. Mongrain et al. further teach that the cantilevered construction allows for the implanted structure to be expandable or flexible to allow any adjustment needed to permit the body to integrate therewith and not require further surgery, paragraphs 12-14. Additionally, it can be said the free ends extend from opposite sides of a base portion. It would have been obvious to one of ordinary skill in the art to utilize cantilevered support elements to provide free ends as taught by Mongrain et al. with the oncoplastic device of Glicksman such that the implant is able to sufficiently remodel in the body if needed. Additionally Glicksman did not disclose a plurality of radiographically visible elements secured at various locations on the three-dimensional support structure. Conklin teaches (paragraph 59) a plurality of radiographically visible elements secured at various locations on the three-dimensional support structure or embedded therein. It would have been obvious to incorporate a plurality of radiographically visible elements secured at various locations on the three- dimensional support structure as taught by Conklin with the device of Glicksman as modified with Mongrain et al. such that the implanted structure is easily identified and its orientation. Regarding claim 3, since the claimed device is disclosed by the prior art (Glicksman’s 3D support structure) with the same structure (open and not covered), it can be construed it is capable of allowing seroma fluid to pass through the three-dimensional support structure so that, after placement of the implant device within a surgically-created cavity, the seroma fluid can promote tissue regrowth within the three-dimensional support structure to at least partially reconstruct a breast, see Figs. 17A,B. Regarding claim 4, it can be seen (Figs. 16A,B) the oncoplastic device of Glicksman includes illustrated ovoid element 354 a planar hoop since it has a flat surface. With respect to claim 5, per the modification with Mongrain it would be obvious to provide the two or more arcuate support elements extending from opposite sides of the single ovoid element over the open center of the single ovoid element as it would be stable and have the ovoid element as the central support as illustrated in how Mongrain has arcuate support members extending along its structure axis. Regarding claim 6, Glicksman discloses (page 4) that the structural support members that can be arcuate and per the teaching with Mongrain would be configured to provide compliance and compressibility to the three-dimensional support structure. Regarding claim 7, Glicksman also discloses (page 4) after placement of the oncoplastic device within the surgically-created cavity, the three-dimensional support structure has a flattened or low profile shape. With respect to claim 8, per the modification with Mongrain to provide flexibility or compressibility, it can be construed that after placement of the oncoplastic within the surgically-created cavity, a height of the three-dimensional support structure is less than a width and a length of the three-dimensional support structure. Regarding claim 9, Conklin teaches (paragraph 59) that the plurality of radiographically visible elements is formed from gold. Regarding claim 11, Conklin teaches the oncoplastic device can be provided with a plurality of radiographically visible elements embedded within the structural support and thus per the modification with Mongrain and Glicksman each of the single ovoid element and two arcuate support elements could be embedded.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 2,6-8,10 are rejected under 35 U.S.C. 103 as being unpatentable over Cionni (5843184) in view if Silvestrini et al. (5300118) and Pipenhagen (2013/0166023). Please note the recitation of “oncoplastic” is just a generic placeholder and note that the claim is a product claim and not limited to any specific use when the claim fails to provide no limitations that would specifically imply a particular field of use. Fig. 5 shows an “oncoplastic” or implant device 36 for placement within a surgically-created cavity, the oncoplastic device comprising: a three-dimensional support structure consisting of a device seen (Fig. 5) as a single element having a longitudinal axis and defining an open center, and two arcuate support elements 44 projecting from the single ovoid base element, the two arcuate support elements extending from opposite sides of the single ovoid base element across the open center, in a direction transverse to the longitudinal axis of the single ovoid base element, wherein at least one of the two or more arcuate support elements has a free, unsupported end. However, Cionni did not state the device to be ovoid in shape. Silvestrini et al. teach (col. 6, lines 48-50) that surgically implanted devices can be constructed with the shape such as an ovoid to conform to the cavity it is replacing. It would have been obvious to one of ordinary skill in the art to provide an alternative shape such as an ovoid as taught by Silvestrini et al. for the implant device of Cionni such that it appropriately matches the site of incision and insertion to stably fit and remain seated in the location of the body. However, Cionni did not disclose a plurality of radiographically visible elements secured at various locations on the three-dimensional support structure. 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. Thus, in giving the claims their broadest reasonable interpretation of the claimed radiographically visible elements secured at various locations one is able to essentially consider any location not a particular structure or configuration is required or limits where or how a radiographically visible element is secured to reasonably fall within the scope of the disclosure for teachings of a scaffold with a “radiographically visible element” at any location. Pipenhagen teaches (paragraph 23) a prosthetic implant provided with a scaffold is to include a positional marker that aids in positioning the implantable scaffold within the tissue site and it is noted that the positional marker may be placed anywhere such that it enables the user/surgeon to be better able to visibly see/visualize the placement of the implantable scaffold which is critical for proper functioning within the patient. Thus, one of ordinary skill in the art is fully capable of securing a plurality of radiographically visible elements on the three dimensional support structure as taught by Pipenhagen to the implantable structure of Cionni as modified by Silvestrini et al. such that the structure is enabled to be properly positioned in the patient for stability and securement appropriately. Regarding claim 6, Cionni shows structures as claimed, the “two arcuate support elements” and at the same level of scope of the claim, thus they are configured to provide compliance and compressibility to the three-dimensional support structure. Regarding claim 7, it can be understood that after placement of the oncoplastic or implant device within the surgically-created cavity, the three-dimensional support structure has a flattened or low-profile shape. With respect to claim 8, clearly the implant device of Cionni has after placement within the surgically-created cavity, a height of the three-dimensional support structure is less than a width and a length of the three-dimensional support structure. Regarding claim 10, Cionni as modified with Silvestrini et al. did not explicitly disclose the plurality of radiographically visible elements is spaced upon an outer surface of each of the ovoid element and the arcuate support elements. Pipenhagen teaches that a plurality of radiographically visible elements can be spaced any location of an outer surface of an implant support, paragraph 23. It would have been obvious to one of ordinary skill in the art to alternatively place the radiographically visible elements on each of the ovoid element and the arcuate support elements per the teaching of Pipenhagen to provide the implant of Cionni in view of Silvestrini et al. the ability to give the surgeon proper aligning capability.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Cionni (5843184) in view if Silvestrini et al. (5300118) and Pipenhagen (2013/0166023) as applied to claim 2, above, and further in view of Felix et al. (2015/01 12334). Cionni in view of Silvestrini et al. as modified by Pipenhagen is explained supra. However, Cionni as modified with Silvestrini et al. and also in view of Pipenhagen did not explicitly disclose there being a therapeutic drug for treatment of cancer, to improve tissue healing, to prevent infection and/or a combination thereof. Felix et al. teach (paragraphs 112, 113) a therapeutic drug for treatment of cancer, to improve tissue healing, to prevent infection and/or a combination thereof. It would have been obvious to one of ordinary skill in the art to incorporate a therapeutic drug for cancer, to improve tissue healing, to prevent infection, and/or a combination thereof as taught by Felix et al. with the oncoplastic or implant device of Cionni as modified with Silvestrini and Pipenhagen in order to enhance the integration of the implant placed in the body and deliver therapeutic material to the site.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Cionni (5843184) in view if Silvestrini et al. (5300118) and Pipenhagen (2013/0166023) and Felix et al. (2015/0112434) as applied to claim 12, above, and further in view of Alejandro (2012/0123535). Cionni as modified by Silvestrini et al. and Pipenhagen and Felix et al. is explained above. However, Cionni in view of Silvestrini et al. and Pipenhagen and Felix et al. did not disclose the therapeutic drug is contained within a plurality of discrete elements spaced about the three-dimensional support structure. Alejandro teaches Fig. 3B that an oncoplastic implant can be provided with a plurality of discrete elements 4 spaced about the three- dimensional support structure to deliver a therapeutic drug. It would have been obvious to one of ordinary skill in the art to incorporate discrete elements as taught by Alejandro with the oncoplastic or implant device of Cionni as modified with Silvestrini et al. and Pipenhagen and Felix et al. such that a chemotherapeutic agent can be effectively delivered, abstract of Alejandro.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ketai et al. (2013/0282059) in view if O’Connell et al. (2015/0018944). Ketai et al. is explained supra. However, Ketai et al. did not disclose a plurality of radiographically visible elements secured at various locations along the open framework body. O’Connell et al. show (Fig. 4) a plurality of radiographically (paragraphs 3,14,42) visible elements 132 secured at various locations along the open framework body. It would have been obvious to incorporate a plurality of radiographically visible elements secured at various locations along the open framework body as taught by O’Connell et al. with the device of Ketai et al. such that the implanted structure is easily identified and its orientation, paragraph 64.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Ketai et al. (2013/0282059) in view of O’Connell et al. (2015/0018944) as applied to claim 15 above, and further in view of Pipenhagen (2013/0166023). Ketai et al. as modified by O’Connell et al. is explained supra. However, Ketai in view of O’Connell did not explicitly disclose the plurality of radiographically visible elements is spaced upon an outer surface of each of the ovoid element or planar hoop and the arcuate support elements and/or embedded within each of the planar hoop and the arcuate support elements. Pipenhagen teaches that a plurality of radiographically visible elements can be spaced any location of an outer surface of an implant support, paragraph 23. It would have been obvious to one of ordinary skill in the art to alternatively place the radiographically visible elements on each of the ovoid element or planar hoop and the arcuate support elements and/or embedded within each of the ovoid element or planar hoop and the arcuate support elements per the teaching of Pipenhagen to provide the implant of Ketai as modified with O’Connell the ability to give the surgeon proper aligning capability.
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Ketai et al. (2013/0282059). Ketai et al. is explained supra. However, Ketai et al. does not explicitly detail the open framework body has an oblate ellipsoid profile. Please note a change in shape involves routine skill in the art and absent any criticality one of ordinary skill is fully capable of making a change in shape to be “oblate ellipsoid” in configuration. Thus it would have been obvious to one of ordinary skill in the art to modify the open framework body of Ketai et al. to be oblate ellipsoid to match or best suit the anatomy site and provide sufficient support across and around the perimeter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799