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's arguments below filed 8/7/2025 have been fully considered but they are not persuasive | moot in view of the new grounds of rejection.
The Applicant asserts on page 7 of the Response:
“Based on the cited references, one of ordinary skill in the art could have arrived at amended claim 1 only by combining unrelated pieces of the cited references.
The only one of the cited references that teaches breast cancer is Carr. However, Carr uses pads that are much thicker (0.12 cm) than the thin film in claimed markers (5 to 15 microns). Carr's thick pads cannot be attached to the entire breast without wrinkling. One of ordinary skill in the art would not have any reason or motivation to modify Carr's thick pads so that they could be attached to the entire breast without wrinkling. Furthermore, one of ordinary skill in the art would have no expectation that Carr's thick pads could be modified so that they could be attached to the entire breast without wrinkling.
For arriving at the examined claims, the Office combines unrelated pieces of unrelated references, which have nothing to do with markers for mammography at all.
For the support recited in the examined claims, the Office cites Davis. For the thickness of the thin film, the Office cites Fabo. For the weakened portion, the Office cites Heicnecke and Nemoto.
Thus, the rejections are based on impermissible hindsight based on the Office's knowledge of Applicant's claims.
Based on the cited references, one of ordinary skill in the art would not have expected that the markers of Examples 3-5 (or Figures 2, 8 and 10) could be attached to the entire breast without wrinkling and when the support of the adhesive examination marker is removed the attachment of the marker to the breast would be maintained.”
In response the examiner respectfully asserts that the claims do not require the adhesive marker to be attached to the entire breast without wrinkling. The claim only requires a thickness of 5 µm or more and 15 µm or less which is taught by Fabo. The office action recites that the motivation to combine is that a thinner film would provide more flexibility to stretch over uneven surfaces such as a breast. Each of the cited references are directed to an adhesive film/pad applied to the skin therefore the references are related. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Claim Objections
Claim 5 is objected to because of the following informalities: claim 5 recites “the portions of the support other than the weakened portion has a breaking strength”. However this should be read as “the portions of the support other than the weakened portion have a breaking strength”.
Claim 5 recites “between the pressure-sensitive adhesive layer and an examination target”. However this should be read as “between the pressure-sensitive adhesive layer and the examination target”.
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 7, 8, and 14-20 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.
Regarding claims 7 and 14, claims 7 and 14 both recite “wherein the support has a polygonal shape”. Claims 7 and 14 are both dependent on claim 1 which recites “the support has a polygonal shape”. Therefore it is unclear if claims 7 and 14 are claiming the same polygonal shape as claim 1 or a different polygonal shape. For examination purposes claims 7 and 14 will be interpreted as “wherein the support has the polygonal shape”.
Claims 8 and 15-20 are also rejected due to their dependency.
Regarding claim 16, claim 16 recites “wherein the support has a perforation in each of the at least two adjacent corners of the polygonal shape of the support”. Claim 16 is dependent on claim 15 which recites “wherein the support has a weakened portion in each of at least two adjacent corners of the polygonal shape of the support”. Claim 16 is also dependent on claim 1 which recites “the weakened portion comprises a perforation or a notch”. Therefore, it’s unclear if the perforation is the weakened portion or if each of the two adjacent corners have a weakened portion and a perforation. For examination purposes claim 16 will be interpreted as “wherein the weakened portion in each of at least two adjacent corners of the polygonal shape of the support comprises a perforation”.
Regarding claim 17, claim 17 recites “wherein the support has a notch in each of the at least two adjacent corners of the polygonal shape of the support”. Claim 17 is dependent on claim 15 which recites “wherein the support has a weakened portion in each of at least two adjacent corners of the polygonal shape of the support”. Claim 17 is also dependent on claim 1 which recites “the weakened portion comprises a perforation or a notch”. Therefore, it’s unclear if the notch is the weakened portion or if the each of two adjacent corners have a weakened portion and a notch. For examination purposes claim 17 will be interpreted as “wherein the weakened portion in each of at least two adjacent corners of the polygonal shape of the support comprises a notch”.
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.
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, 14, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Carr (US 5983124) and further in view of Davis (US 5372589), Fabo (US 20080114278), Heinecke (US 20010027285), and Levitt (US 20020000232).
Regarding Claim 1, Carr discloses an adhesive examination marker (Col.9 lines 33-34 – “the pads may be mildly adhered to a patient's chest”, Col. 9 lines 43-44 – “the pads 30r, and 30l, carry grids 70r, and 70l, respectively, to facilitate targeting Selected areas”), comprising:
a base film having a front surface and a rear surface facing away from the front surface (Fig. 6, Col. 9 lines 25-35 disclose that the pads are made of a thermally insulating material which has an underside adhered to the patient’s chest, Col. 9 lines 43-45 disclose that the pads carry grids to facilitate targeting selected areas therefore there is a front surface);
a pressure-sensitive adhesive layer disposed on the rear surface of the base film (Fig. 6, Col. 9 lines 30-34 – “The pads 30r, 30l…preferably their undersides are covered with a release adhesive so that the pads may be mildly adhered to a patient's chest”); and
wherein the base film has a coordinate grid configured to guide a scanning portion in an examination target, wherein the coordinate grid is disposed within a region surrounded by [… a border] (Fig. 6, Col. 9 lines 43-45 – “the pads 30r and 30l carry grids 70r and 70l, respectively, to facilitate targeting selected areas of the underlying breasts”),
the adhesive examination marker is configured to adhere to a human breast and that an area of the adhesive examination marker covers the human breast entirely (Fig. 6, Col.9 lines 28-34 – “The pads are sized to cover the breasts Br and Bl and the areas around the breasts…preferably their undersides are covered with a release adhesive so that the pads may be mildly adhered to a patient's chest”).
Conversely Carr does not teach a support attached to the front surface of the base film and having a shape along the whole of a periphery of the base film as viewed perpendicular to the front surface of the base film, the support including a portion that connects a first point and a second point on the periphery of the base film, the first and second points facing each other across a central portion of the base film,
wherein the base film has a uniform thickness of 5 µm or more and 15 µm or less over the entirety of the base film, wherein:
the support includes a weakened portion that is more easily broken than portions of the support other than the weakened portion,
the weakened portion comprises a perforation or a notch,
the support has a polygonal shape entirely surrounding the central portion of the base film or a closed annular shape entirely surrounding the central portion of the base film.
However Davis discloses a support attached to the front surface of the base film and having a shape along the whole of a periphery of the base film as viewed perpendicular to the front surface of the base film (Figs. 1 and 1A protective cover 18 is attached to the front surface of the film 12, as seen in Fig. 1 the protective cover 18 has a shape along the whole of a periphery of the film 12), the support including a portion that connects a first point and a second point on the periphery of the base film, the first and second points facing each other across a central portion of the base film (one with ordinary skill in the art would recognize the polygonal shape of the protective cover 18 [support] would have a side that includes two points at two of the corners of the polygon and the two points [corners] face each other across a central portion of the base film),
As cited above Carr discloses a base film that has a coordinate grid that is disposed in a region that is surrounded by a perimeter and Davis discloses a base film and a support surrounding the base film therefore it would be obvious to one with ordinary skill in the art to combine the teachings of Carr and Davis to surround the coordinate grid of Carr with the support of Davis.
the support has a polygonal shape entirely surrounding the central portion of the base film or a closed annular shape entirely surrounding the central portion of the base film (As seen in Fig. 1 the protective cover 18 [support] is a polygonal shape entirely surrounding the central portion of the base film once the protective door is removed).
Davis is an analogous art considering it is in the field of an adhesive film placed on the body.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr to incorporate the support frame of Davis to achieve the same results. One would have motivation to combine because it “provides an efficient method of handling” (Davis – Col. 6 lines 46-47).
Conversely Carr and Davis do not teach wherein the base film has a uniform thickness of 5 µm or more and 15 µm or less over the entirety of the base film, wherein:
the support includes a weakened portion that is more easily broken than portions of the support other than the weakened portion,
the weakened portion comprises a perforation or a notch,
However Fabo discloses wherein the base film has a uniform thickness of 5 µm or more and 15 µm or less over the entirety of the base film ([0025] – “The thickness of the plastic film preferably lies between 12 and 25 micrometres”, MPEP 2144.05 (I) – “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists”).
Fabo is an analogous art considering it is in the field of an adhesive film placed on the body.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr to incorporate the thickness of the film of Fabo to achieve the same results. One would have motivation to combine because a thinner film would provide more flexibility to follow unevenness of the skin and allow more flexibility to stretch over any unevenness.
Conversely Carr, Davis, and Fabo do not teach the support includes a weakened portion that is more easily broken than portions of the support other than the weakened portion,
the weakened portion comprises a perforation or a notch,
However Heinecke discloses the support includes a weakened portion that is more easily broken than portions of the support other than the weakened portion ([0032] – “the carrier frame 26 has several nonlinear cuts or slits 30, 32, 34 and 36… slits 30, 32, 34 or 36 provides a beginning point at which the carrier frame 26 may be lifted from backing 14 and peeled away”).
Heinecke is an analogous art considering it is in the field of an adhesive placed on the body.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr and Davis to incorporate the weakened portion of the support of Heinecke to achieve the same results. One would have motivation to combine because it allows one to more easily remove the protective cover [support] after the adhesive has been placed on the body and therefore provide more flexibility.
Conversely Carr, Davis, Fabo, and Heinecke do not teach the weakened portion comprises a perforation or a notch.
However Levitt discloses the weakened portion comprises a perforation or a notch ([0010] – “The tear lines may conveniently be a line of perforations in the sheet of material”).
Levitt is an analogous art considering it is in the field of an adhesive film placed on the body.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr, Davis, and Heinecke to incorporate the weekended portion of the support of Levitt to achieve the same results. One would have motivation to combine because it would allow the support to more easily conform to the desired part of the body with portions that can be easily torn.
Regarding claim 6, Carr, Davis, Fabo, Heinecke, and Levitt disclose all the elements of the claimed invention as cited in claim 1.
Conversely Carr does not teach wherein as viewed perpendicular to the front surface of the base film, the weakened portion is disposed in an area of the support including a point with the largest distance from the center of gravity of the base film.
However Heinecke discloses wherein as viewed perpendicular to the front surface of the base film, the weakened portion is disposed in an area of the support including a point with the largest distance from the center of gravity of the base film (As seen in Fig. 1 slits 30 and 32 are points with the largest distance from the center of gravity of the base film).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr and Davis to incorporate the area of the weakened portion of the support of Heinecke to achieve the same results. One would have motivation to combine because “slits 30, 32, 34 and 36 strategically positioned around the frame 26 allow for distinct sections of the carrier frame 26 to be removed without removing the other sections to aid in the delivery over body contours” (Heinecke [0032]).
Regarding claim 7, Carr, Davis, Fabo, Heinecke, and Levitt disclose all the elements of the claimed invention as cited in claim 1.
Conversely Carr does not teach the support has a polygonal shape with a first side including the first point, a second side including the second point, and a connection side connecting the first side and the second side;
the support has a first corner portion formed by the first side and the connection side, and a second corner portion formed by the second side and the connection side; and
an inner periphery of the first corner portion and the second corner portion has an arc shape with a center of curvature on the base film.
However Davis discloses wherein the support has a polygonal shape with a first side including the first point, a second side including the second point, and a connection side connecting the first side and the second side (one with ordinary skill in the art would recognize the polygonal shape of the protective cover 18 [support] would have a first side including two points at two of the corners of the polygon and a second side including two different points at two of the corners on the opposite side of the polygon [the longer sides of the polygon], and two sides [shorter sides of the polygon] of the polygon that connect the first side and second side therefor the protective cover 18 [support] reads on the limitation);
the support has a first corner portion formed by the first side and the connection side, and a second corner portion formed by the second side and the connection side (as recited above the longer sides of the polygon each include two points at two of the corners and the shorter sides of the polygon connect the first longer side to the second longer side at the corners to form a polygon therefore the protective cover 18 [support] reads on the limitation); and
an inner periphery of the first corner portion and the second corner portion has an arc shape with a center of curvature on the base film (Fig. 1 of the protective cover 18 [support] shows an inner periphery of the corners having an arc shape with a center of curvature on the base film).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr to incorporate the support frame of Davis to achieve the same results. One would have motivation to combine because it “provides an efficient method of handling” (Davis – Col. 6 lines 46-47).
Regarding claim 8, Carr, Davis, Fabo, Heinecke, and Levitt disclose all the elements of the claimed invention as cited in claims 1 and 7.
Conversely Carr does not teach wherein the support includes, in at least one of the first corner portion and the second corner portion, a weakened portion that is more easily broken than portions of the support other than the weakened portion.
As cited above Davis discloses the first corner portion and the second corner portion (one with ordinary skill in the art would recognize the polygonal shape of the protective cover 18 [support] would have a side that includes two points at two of the corners of the polygon),
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr to incorporate the support frame and protective layer of Davis to achieve the same results. One would have motivation to combine because it “provides an efficient method of handling” (Davis – Col. 6 lines 46-47).
Conversely Carr and Davis do not teach wherein the support includes, in at least one of the first corner portion and the second corner portion, a weakened portion that is more easily broken than portions of the support other than the weakened portion.
However Heinecke discloses wherein the support includes, in at least one of the first corner portion and the second corner portion, a weakened portion that is more easily broken than portions of the support other than the weakened portion ([0032] – “the carrier frame 26 has several nonlinear cuts or slits 30, 32, 34 and 36”, as seen slits 30, 32, and 34 are placed in regions with sharper curves therefore it would be obvious to one with ordinary to place the slits [weakened portion] into corner portions of Kusama where there is more curvature).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr and Davis to incorporate the area of the weakened portion of the support of Heinecke to achieve the same results. One would have motivation to combine because “slits 30, 32, 34 and 36 strategically positioned around the frame 26 allow for distinct sections of the carrier frame 26 to be removed without removing the other sections to aid in the delivery over body contours” (Heinecke [0032]).
Regarding claim 9, Carr, Davis, Fabo, Heinecke, and Levitt disclose all the elements of the claimed invention as cited in claims 1.
Conversely Carr does not teach wherein the support has a rear surface facing the base film, and a front surface facing away from the rear surface; and the rear surface of the support has a surface roughness greater than that of the front surface of the support.
However Davis discloses wherein the support has a rear surface facing the base film, and a front surface facing away from the rear surface (It can be seen in Fig. 1A that the protective cover 18 has a rear surface facing the film 12 and a front surface faces away from the rear surface);
Davis does not explicitly disclose the rear surface of the support has a surface roughness greater than that of the front surface of the support.
However it would be obvious to one of ordinary skill in the art for the rear surface of the support has a surface roughness greater than that of the front surface of the support. One with ordinary skill in the art would recognize a surface with a greater roughness would create more friction between two surfaces therefore it would create a better adhesion between the tab and the base layer. The protective layer 18 is used as a stiff edge to apply pressure so that the film adheres to the site therefore one would want a good adhesion between the protective layer 18 and the film 12 so that the support provided by the protective layer 18 does not move while the adhesive film is being placed on a desired spot on the body.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr to incorporate the support frame of Davis to achieve the same results. One would have motivation to combine because it “provides an efficient method of handling” (Davis – Col. 6 lines 46-47).
Regarding claim 10, Carr, Davis, Fabo, Heinecke, and Levitt disclose all the elements of the claimed invention as cited in claim 1.
Conversely Carr does not teach further comprising a protective layer covering a portion of the front surface of the base film on an inner side of the support as viewed perpendicular to the front surface of the base film.
However Davis discloses further comprising a protective layer covering a portion of the front surface of the base film on an inner side of the support as viewed perpendicular to the front surface of the base film (Figs. 1 and 1A protective door 18a, Col. 7 lines 12-14 – “showing layered disposition of the film 12, with open fenestra 20, as protected by peel-away protective cover 18, with peel-away protective door 18A).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr to incorporate the support frame and protective layer of Davis to achieve the same results. One would have motivation to combine because it “provides an efficient method of handling” (Davis – Col. 6 lines 46-47).
Regarding claim 14, Carr, Davis, Fabo, Heinecke, and Levitt disclose all the elements of the claimed invention as cited in claim 1.
Conversely Carr does not teach wherein the support has a polygonal shape entirely surrounding the central portion of the base film.
However Davis discloses wherein the support has a polygonal shape entirely surrounding the central portion of the base film (As seen in Fig. 1 the protective cover 18 [support] is a polygonal shape entirely surrounding the central portion of the base film once the protective door is removed).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr to incorporate the support frame of Davis to achieve the same results. One would have motivation to combine because it “provides an efficient method of handling” (Davis – Col. 6 lines 46-47) and a polygon provides a shape that can entirely cover the breast with the adhesive marker of Carr.
Regarding claim 21, Carr, Davis, Fabo, Heinecke, and Levitt disclose all the elements of the claimed invention as cited in claim 1.
Conversely Carr does not teach wherein the support has the closed annular shape entirely surrounding the central portion and wherein the support includes at least one perforation.
However Davis discloses wherein the support has the closed annular shape entirely surrounding the central portion (As seen in Fig. 1 the frame of the protective cover 18 [support] surrounds a central portion, Col. 7 lines 30-33 – “The device 10 consists of a sheet of transparent film 12, which may be rectangular in shape, and equivalently may be circular, oval”, one with ordinary skill in the art would find it obvious to use a circular or oval shaped handling frame when the film is circular or oval shaped).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr to incorporate the support frame of Davis to achieve the same results. One would have motivation to combine because it “provides an efficient method of handling” (Davis – Col. 6 lines 46-47) and an annular shape provides a shape that can entirely cover the breast with the adhesive marker of Carr.
Conversely Carr and Davis do not teach […] wherein the support includes at least one perforation.
However Heinecke discloses wherein the support includes a […weakened portion] ([0032] – “the carrier frame 26 has several nonlinear cuts or slits 30, 32, 34 and 36… slits 30, 32, 34 or 36 provides a beginning point at which the carrier frame 26 may be lifted from backing 14 and peeled away”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr and Davis to incorporate a weakened portion of the support of Heinecke to achieve the same results. One would have motivation to combine because it allows one to more easily remove the protective cover [support] after the adhesive has been placed on the body and therefore provide more flexibility.
Conversely Carr, Davis, and Heinecke do not teach […] wherein the support includes at least one perforation.
However Levitt discloses wherein the support includes at least one perforation ([0010] – “The tear lines may conveniently be a line of perforations in the sheet of material”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr, Davis, and Heinecke to incorporate the weekended portion of the support of Levitt to achieve the same results. One would have motivation to combine because it would allow the support to more easily conform to the desired part of the body with portions that can be easily torn.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Carr (US 5983124), Davis (US 5372589), Fabo (US 20080114278), Heinecke (US 20010027285), and Levitt (US 20020000232) as applied to claim 1 above, and further in view of Nemoto (JP2007291154A).
Regarding claim 5, Carr, Davis, Fabo, Heinecke, and Levitt disclose all the elements of the claimed invention as cited in claim 1.
Conversely Carr does not teach wherein the portions of the support other than the weakened portion has a breaking strength higher than that of the base film; and
an adhesion strength between the support and the front surface of the base film is higher than that between the pressure-sensitive adhesive layer and an examination target.
As cited above Heinecke discloses the weakened portions.
Davis discloses wherein the portions of the support other than the weakened portion has a breaking strength higher than that of the base film (Col. 8 lines 10-11 – “Use the stiff edged 18 to apply pressure so the film will adhere to the site” therefore portions of the protective cover 18 that would not be weakened by the weakened portions of Heinecke would have a higher breaking strength than the base film); and
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr to incorporate the support frame and protective layer of Davis to achieve the same results. One would have motivation to combine because it “provides an efficient method of handling” (Davis – Col. 6 lines 46-47).
Conversely Carr and Davis do not teach an adhesion strength between the support and the front surface of the base film is higher than that between the pressure-sensitive adhesive layer and an examination target
However Nemoto discloses an adhesion strength between the support and the front surface of the base film is higher than that between the pressure-sensitive adhesive layer and an examination target ([0018] – “the base sheet 510 and the tab sheet 540 may be fixed by heat fusion”).
Nemoto is an analogous art considering it is in the field of an adhesive placed on the body.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr and Davis to incorporate the adhesion strength between the support and the base film of Nemoto to achieve the same results. One would have motivation to combine because the protective layer 18 of Davis is used as a stiff edge to apply pressure so that the film adheres to the site therefore one would want a stronger adhesion between the protective layer 18 and the film 12 so that the support provided by the protective layer 18 does not move while the adhesive film is being placed on a desired spot on the body.
Claims 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Carr (US 5983124), Davis (US 5372589), Fabo (US 20080114278), Heinecke (US 20010027285), and Levitt (US 20020000232) as applied to claim 14 above, and further in view of Alley (US 20130331707).
Regarding claim 15, Carr, Davis, Fabo, Heinecke, and Levitt disclose all the elements of the claimed invention as cited in claims 1 and 14.
Conversely Carr does not teach wherein the support has a weakened portion in each of at least two adjacent corners of the polygonal shape of the support.
However Alley discloses wherein the support has a weakened portion in each of at least two adjacent corners of the polygonal shape of the support ([0136] – “frame 1520 includes one or more lines of weakness 1544 disposed about frame 1520 at various positions including, for example, in the general vicinity of corners”).
Alley is an analogous art considering it is in the field of an adhesive film placed on the body.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr and Davis to incorporate the weekended portion in the corners of Alley to achieve the same results. One would have motivation to combine because it would allow “increasing the flexibility of frame” (Alley [0136]).
Regarding claim 16, Carr, Davis, Fabo, Heinecke, Levitt, and Alley disclose all the elements of the claimed invention as cited in claims 1, 14, and 15.
Conversely Carr does not teach wherein the support has a perforation in each of the at least two adjacent corners of the polygonal shape of the support.
However Alley discloses wherein the support has a […weakened portion] in each of at least two adjacent corners of the polygonal shape of the support ([0136] – “frame 1520 includes one or more lines of weakness 1544 disposed about frame 1520 at various positions including, for example, in the general vicinity of corners”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr and Davis to incorporate the weekended portion in the corners of Alley to achieve the same results. One would have motivation to combine because it would allow “increasing the flexibility of frame” (Alley [0136]).
Conversely Carr and Alley do not teach wherein the support has a perforation […].
However Levitt discloses wherein the support has a perforation ([0010] – “The tear lines may conveniently be a line of perforations in the sheet of material”).
One with ordinary skill in the art would find it obvious to use the perforations of Levitt in the weakened portions of Alley to provide areas to be easily torn to more easily remove the handling frame of Davis.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr, Davis, Heinecke, and Alley to incorporate the weekended portion of the support of Levitt to achieve the same results. One would have motivation to combine because it would allow the support to more easily conform to the desired part of the body with portions that can be easily torn.
Regarding claim 17, Carr, Davis, Fabo, Heinecke, Levitt, and Alley disclose all the elements of the claimed invention as cited in claims 1, 14, and 15.
Conversely Carr does not teach wherein the support has a notch in each of the at least two adjacent corners of the polygonal shape of the support.
However Alley discloses wherein the support has a notch in each of the at least two adjacent corners of the polygonal shape of the support (Fig. 5 shows the support 1260 with a notch 1266 in one of the corners, [0157] – “individual guides 1814 a and 1814 b preferably include a notch or some other feature”, Fig. 16D shows notches 1814 in areas that can be considered as two adjacent corners).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr and Davis to incorporate the notches of Alley to achieve the same results. One would have motivation to combine because it would allow “increasing the flexibility of frame” (Alley [0136]).
Regarding claims 18, 19 and 20, Carr, Davis, Fabo, Heinecke, Levitt, and Alley disclose all the elements of the claimed invention as cited in claims 1, 14, 15, 16, and 17.
Conversely Carr does not teach wherein the support has a rectangular shape.
However Davis discloses wherein the support has a rectangular shape (As seen in Fig. 1 the protective cover 18 [support] is a rectangular shape entirely surrounding the central portion of the base film once the protective door is removed, Col. 7 lines 30-32 – “The device 10 consists of a sheet of transparent film 12, which may be rectangular in shape”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carr to incorporate the support frame of Davis to achieve the same results. One would have motivation to combine because it “provides an efficient method of handling” (Davis – Col. 6 lines 46-47) and a rectangular shape provides a shape that can entirely cover the breast with the adhesive marker of Carr.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20160278865 (Capote) – discloses a surgical drape with a base layer, an adhesive layer, and a plurality of tracking elements.
US 5820877 (Yamaguchi) – discloses an adhesive patch with notches in areas to be torn.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/R.C.L./Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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