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 .
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.
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.
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 3/16/26. The claims 1-5, 7-10, 20, 22-34 are pending. Claims 6, 11-19, and 21 are cancelled. Claim 1 has been amended.
Response to Arguments
Applicant’s arguments, filed 3/16/26 with respect to the rejections of claims 1, 7-10, 20, 21, and 34 under 35 U.S.C. 103 as being unpatentable over McClellan (US2011/0153017) in view of Gerow (US4795463) have been fully considered but they are not persuasive. Applicant has amended claim 1 to include the limitations of canceled claim 21.
Applicant argues with regard to claim 1, the combination of McClellan with Gerow does not teach “the orientation indicator visible along an anterior portion of the expandable shell”. Applicant argues, the orientation indicator of Gerow is a pattern or configuration of radiopaque label strips applied to an external surface of a prosthesis. And further argues, the strips are identified on a mammogram and would therefore not be visible as claimed. Examiner disagrees, there is no recitation of the orientation indicator being visible to the human eye or the orientation visible only in the visible light spectrum. The claim merely recites the orientation indicator is visible; therefore, the orientation indicator is visible when viewed under radiographic imaging. Where a practitioner could view the orientation indicator under radiographic imaging in the same manner as claimed.
Applicant further argues, Gerow is not a tissue expansion device, and therefore would not have included an injection port as claimed. Examiner makes notice, Gerow is not modified to include an injection port. Gerow is relied upon for a teaching of an orientation indicator that is along the major axis of a breast implantation device. As stated in the rejection, Gerow does not explicitly teach the line extending from an injection port to a first tab. However, the reference line (orientation indicator) of Gerow is along the major axis (Y axis) on the outer surface. Therefore, when the reference line is applied to the implant of McClellan, the vertical line would extend from the first tab to the injection port, since a line between the first tab and the injection port of McClellan (see Fig. 14B of McClellan) would be along the major axis (Y axis) and because Gerow teaches the vertical line extends along the major axis (Y axis, C7:L10-20). Applicant argues, the device of Gerow is symmetrical and there is no indication that the line needs to be in any particular orientation. Examiner disagrees as stated in C7:L10-20 of Gerow “label strips intersect on the top and bottom surfaces of the prosthesis when viewed form above”. Therefore, the orientation indicators of Gerow are used for the same purpose as the claimed invention to indicate the orientation of the implant as described in C8:L60-65.
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). Furthermore, the orientation indicator as taught by Gerow is for determining whether the implant is properly implanted within the body in the same manner as the claimed invention.
Applicant’s arguments, filed 3/16/26 with respect to the rejections of claims 22-29 under 35 U.S.C. 103 as being unpatentable over McClellan (US2011/0153017) in view of Albrecht (US2017/0304038) have been fully considered but they are not persuasive. Applicant argues, Albrecht does not teach, disclose, or discuss “the first tab comprises an attribute different from an attribute of the remainder of the plurality of tabs”. Stating that the reinforcements 12 of Albrecht are not tabs. Examiner disagrees, as stated in paragraph [0032] the reinforcements can act as a tab by being selectively released and cooperating with portions of the implant. Furthermore, as discussed in paragraph [0035], the reinforcement is described as being “diminished” or having a portion removed that would have the same structure as the claimed tab. Therefore, the rejection has been maintained.
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 20filing 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.
Claims 1, 7-10, 20, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over McClellan (US2011/0153017) in view of Gerow (US4795463).
Regarding claim 1, McClellan discloses a tissue expansion device (Figs. 14A-14B) for temporary surgical implantation beneath skin of a patient and for removal upon expansion of overlying tissue, the device comprising: an expandable shell (Fig. 14A – implant shell 1410) having an expandable chamber (Paragraph 0130), an anterior portion (Fig. 14A – located near the top of the figure), and a posterior portion (Fig. 14A – located near the bottom of the figure); a plurality of tabs coupled to the posterior portion of the expandable shell (Fig. 14B – tabs 1450, Paragraph 0136), wherein a first tab of the plurality of tabs is positioned at a bottom portion of the expandable shell (See Fig. 14B below); an injection port configured to permit injection of fluid into the expandable chamber (Fig. 14B – pocket port 1400).
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McClellan does not disclose an orientation indicator comprising a vertical line extending from the injection port to the first tab.
Gerow teaches a prosthesis for implantation into a breast that is labeled (see Abstract). The label strips (a) as shown in Fig. 1 are applied to the external surface of the envelope of the spheroid prosthesis along the direction of its X and Y axis (see Fig. 1, C7:L10-20; the label strips are interpreted as the claimed orientation indicator comprising a vertical line).
Although Gerow does not explicitly teach the line extending from an injection port to a first tab, the reference line of Gerow is along the major axis (Y axis) on the outer surface. Therefore, when the reference line is applied to the implant of McClellan, the vertical line would extend from the first tab to the injection port, since a line between the first tab and the injection port of McClellan (see Fig. 14B of McClellan) would be along the major axis (Y axis) and because Gerow teaches the vertical line extends along the major axis (Y axis, C7:L10-20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of McClellan to include an orientation indicator comprising a vertical line extending from the injection port to the first tab, as taught by Gerow, for the purpose of allowing a surgeon to align the reference line with a vertical orientation during use to ensure proper orientation of the implant during and/or after implantation (C7:45-50 of Gerow).
The modified invention of McClellan/Gerow further teaches wherein the orientation indicator is visible along an anterior portion of the expandable shell (the reference line of Gerow is along the Y-axis and therefore indicates top and bottom portions and the label is on the outer surface thereof, C5:L50-54 of Gerow; therefore, would be added to the anterior surface of the implant shell 1410 of McClellan; the reference line as taught by Gerow would be visible under radiographic imaging).
Regarding claim 7, McClellan/Gerow makes obvious the device of Claim 1. McClellan (Fig. 14B) further discloses wherein each of the plurality of tabs extends in a radially outward direction relative to a center position of the device (Fig. 14B depicts the tabs 1450 extending in a radially outward direction relative to the center).
Regarding claim 8, McClellan/Gerow makes obvious the device of Claim 7. McClellan (Fig. 14B) further discloses wherein the plurality of tabs are positioned circumferentially about the posterior portion (Fig. 14A – located near the bottom of the figure) of the expandable shell (Fig. 14B depicts the tabs 1450 positioned circumferentially around the shell).
In another embodiment, McClellan teaches that there can be anywhere from 1-10 or greater amounts of tabs and the tabs are evenly spaced about the circumference (Paragraph 0092). If six tabs were used (Paragraph 0092 expressly states six) and placed evenly around the circumference as taught by McClellan, each tab would be approximately 60 degrees apart.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the number of tabs of McClellan in the embodiment of Figs. 14A-14B in view of Gerow to comprise six tabs which are spaced 60 degrees apart, as suggested by another embodiment of McClellan, in order for the device to be effectively sewn into a chest wall to prevent the implant from being turned over (Paragraph 0093).
Regarding claim 9, McClellan/Gerow makes obvious the device of Claim 1.
In another embodiment, McClellan teaches that there can be anywhere from 1-10 or greater amounts of tabs and the tabs are evenly spaced about the circumference (Paragraph 0092). If six tabs were used and placed evenly around the circumference as taught by McClellan (Paragraph 0092 expressly states six tabs and that they can be evenly spaced) the first tab would be located at the 6 o’clock position as shown in Fig. 14B, the other tabs would then be located at the 2 o’clock, 4 o’clock, 8 o’clock, 10 o’clock, and 12 o’clock position.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the number and spacing of tabs of McClellan (Figs. 14A-14B) in view of Gerow to comprise six tabs which are located at the 12 o’clock, 2 o’clock, 4 o’clock, 6 o’clock, 8 o’clock, and 10 o’clock position, as taught by the other embodiment of McClellan, in order for the device to be sewn into a chest wall to prevent the implant from being turned over (Paragraph 0093).
Regarding claim 10, McClellan/Gerow makes obvious the device of Claim 9. McClellan further discloses wherein the first tab is positioned at the 6 o'clock position (Fig. 14B depicts one of the tabs 1450 is located in the 6 o’clock position).
Regarding claim 20, McClellan/Gerow makes obvious the device of Claim 1, the modified invention further discloses wherein the orientation indicator is visible during an implantation procedure (the modified implant shell 1410 of McClellan with the reference line of Gerow is intended to be visible by the surgeon for proper orientation during implantation, C7:L45-50 of Gerow).
Regarding claim 34, McClellan/Gerow makes obvious the device of Claim 1; yet, does not explicitly disclose wherein the orientation indicator is formed along an interior surface of the expandable shell. However, it would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to have the orientation indicator of the implant of McClellan/Gerow to be formed on an interior surface of the expandable shell, since Applicant has not disclosed that having the orientation indicator formed along an interior of the expandable shell is used for a particular purpose or solves a stated problem. Gerow teaches the labels being radiopaque strips that would be visualized whether external or internal of the implant (C9:L31-34). One of ordinary skill in the art, would have expected the implant of McClellan/Gerow and the claimed invention to perform the same function of orienting the implant with the guidance of the orientation indicator equally well. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant of McClellan/Gerow to have the orientation indicator formed along an interior surface of the expandable shell as a matter of obvious design choice within the level of skill in the art.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over McClellan in view of Gerow, as applied to claim 1 above, and in further view of Albrecht et al. (US2017/0304038) and Gramalla (EP1600118).
Regarding claim 2, McClellan/Gerow makes obvious the device of Claim 1, but does not disclose wherein the first tab is any of white or transparent, and the other of the plurality of tabs are non-white or transparent.
Albrecht discloses a soft surgical implant and teaches wherein a first tab of the plurality of tabs comprises a first color different from a second color of a remainder of the plurality of tabs (Paragraph 0045 – reinforcements (tabs) can be differently colored meaning the first reinforcement (tab) would be a different color than the other reinforcements (tabs)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the color of the first tab of McClellan in view of Gerow to be a different color than the other tabs, as taught by Albrecht, for the purpose of differentiating between different implant portions (Albrecht: Paragraph 0045), which would aid in determining proper orientation of the implant and distinguish between the different tabs.
Neither McClellan, Gerow, nor Albrecht discloses wherein the first tab is white or transparent and the other tabs are non-white or transparent.
Gramalla discloses a soft surgical implant and teaches white threads can be used to distinguish the extensions (tabs) from the implant (Paragraph 0028). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the color of some of the tabs of the implant of McClellan in view of Gerow and Albrecht to be white, as taught by Gramalla.
One of ordinary skill in the art before the effective filing date of the claimed invention would understand that the combination of the different colored tabs of McClellan in view of Albrecht with the white identifier of Gramalla would teach that one tab would be white while the rest of the tabs would be a different color, which is used to simplify the symmetrical fixation of the implant in the body (Paragraph 0028 of Gramalla).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over McClellan in view of Gerow, as applied to claim 1 above, and in further view of Albrecht et al. (US2017/0304038) and Chu et al. (US2013/0282034).
Regarding claim 3, McClellan/Gerow makes obvious the device of Claim 1, but does not disclose wherein, except for the first tab, the plurality of tabs are blue.
Albrecht discloses a soft surgical implant and teaches wherein a first tab of the plurality of tabs comprises a first color different from a second color of a remainder of the plurality of tabs (Paragraph 0045 – reinforcements (tabs) can be differently colored meaning the first reinforcement (tab) would be a different color than the other reinforcements (tabs)).
Chu also discloses a surgical implant and teaches blue is a known tab color in the art (Paragraph 0053).
Given the teachings of Albrecht and Chu, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the colors of the tabs of the implant of McClellan in view of Gerow such that with the exception of the first tab, the plurality of tabs are blue. Doing so would enable the user to distinguish the first tab from the remainder of the plurality of tabs.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over McClellan in view of Gerow, as applied to claim 1 above, and in further view of Davila et al. (US2016/0262835).
Regarding claims 4 and 5, McClellan/Gerow makes obvious the device of claim 1, but does not disclose wherein the first tab comprises an attribute different from the other of the plurality of tabs, wherein the attribute consists of at least of one a size of the tab, a shape of the tab, or a material of the tab.
Davila discloses a tissue expander and teaches wherein the first tab comprises an attribute different from the other of the plurality of tabs, wherein the attribute is at least a size of the tab (Fig. 5 – one of the fixation tabs is larger than the other two).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the attribute of the first tab of McClellan in view of Gerow to be different than an attribute of the other tabs, wherein the attribute is at least a size of the tab, as taught by Davila, for the purpose of aiding the surgeon in securing the expander to maintain its position during expansion (Paragraph 0023 of Davila).
Claim 22-29 are rejected under 35 U.S.C. 103 as being unpatentable over McClellan in view of Albrecht et al. (US Pub. No 2017/0304038 A1).
Regarding claim 22, McClellan discloses a tissue expansion device (Figs. 14A-14B) for temporary surgical implantation beneath skin of a patient and for removal upon predetermined expansion of overlying tissue, the device comprising:
an expandable shell (Fig. 14A – implant shell 1410) forming an expandable chamber (Paragraph 0130), the shell having an anterior portion (Fig. 14A – located near the top of the figure) and a posterior portion (Fig. 14A – located near the bottom of the figure);
a plurality of tabs coupled to the posterior portion of the expandable shell (Fig. 14B – tabs 1450, Paragraph 0136), wherein a first tab of the plurality of tabs is positioned at a bottom portion of the expandable shell (see Fig. 14B from the rejection of claim 1); and
an injection port configured to permit injection of fluid into the expandable chamber (Fig. 14B – pocket port 1400).
McClellan does not explicitly disclose the first tab comprises an attribute different form an attribute of the remainder of the plurality of tabs. Albrecht discloses a soft surgical implant and teaches wherein a first tab of the plurality of tabs comprises a first color different from a second color of a remainder of the plurality of tabs (Paragraph 0045 – reinforcements (tabs) can be differently colored meaning the first reinforcement (tab) would be a different color than the other reinforcements (tabs)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the color of the first tab of McClellan to be a different color than the other tabs, as taught by Albrecht, for the purpose of differentiating between different implant portions (Albrecht: Paragraph 0045), which would aid in determining proper orientation of the implant and distinguish between the different tabs.
Regarding claim 23, McClellan in view of Albrecht makes obvious the device of claim 22, Albrecht further teaches wherein the attribute comprises at least one of a color of the tab, a size of the tab, a shape of the tab, or a material of the tab (see Paragraph 0045).
Regarding claim 24, McClellan in view of Albrecht makes obvious the device of claim 22; yet, does not explicitly disclose wherein the first tab is any of white or transparent, and the other of the plurality of tabs are non-white or transparent. Albrecht teaches the tab can be any color different from the other tabs (Paragraph 0045). It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to have the first tab be white and the other tabs non-white because Applicant has not disclosed having the first tab be white and the other tabs be non-white provides an advantage, is used for a particular purpose, or solves a stated problem. Further, the instant specification paragraph 0039 recites a variety of colors for the tabs. One of ordinary skill in the art, furthermore, would have the colors as provided by McCllelan in view of Albrecht, and applicant’s invention, to perform equally well with the colors taught by Albrecht or white colored first tab and other colors for the tabs because both color coded tabs would perform the same function of differentiating the tabs to aid in proper orientation of the implant equally well.
Regarding claim 25, McClellan in view of Albrecht makes obvious the device of claim 22; yet, does not explicitly disclose wherein, except for the first tab, the plurality of tabs are blue. Albrecht teaches the tab can be any color different from the other tabs (Paragraph 0045). It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to have the plurality of tabs be blue because Applicant has not disclosed having the plurality of tabs be blue provides an advantage, is used for a particular purpose, or solves a stated problem. Further, the instant specification paragraph 0039 recites a variety of colors for the tabs. One of ordinary skill in the art, furthermore, would have the colors as provided by McCllelan in view of Albrecht, and applicant’s invention, to perform equally well with the colors taught by Albrecht or blue colored plurality of tabs because both color coded tabs would perform the same function of differentiating the tabs to aid in proper orientation of the implant equally well.
Regarding claim 26, McClellan in view of Albrecht makes obvious the device of claim 22, McClellan further discloses wherein each of the plurality of tabs extends in a radially outward direction relative to a center position of the device (see Fig. 14B).
Regarding claim 27, McClellan in view of Albrecht makes obvious the device of claim 26, McClellan further discloses wherein the plurality of tabs are positioned circumferentially about the posterior portion of the expandable shell (Paragraph 0092); yet, does not explicitly disclose each of the plurality of tabs are spaced apart from an adjacent tab of the plurality of tabs by approximately 60 degrees. In another embodiment, McClellan teaches that there can be anywhere from 1-10 or greater amounts of tabs and the tabs are evenly spaced about the circumference (Paragraph 0092). If six tabs were used and placed evenly around the circumference as taught by McClellan (Paragraph 0092 expressly states six tabs and that they can be evenly spaced) the tabs would be spaced apparat approximately 60 degrees.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the number and spacing of tabs of McClellan (Figs. 14A-14B) to comprise tabs spaced apart 60 degrees, as taught by the other embodiment of McClellan, in order for the device to be sewn into a chest wall to prevent the implant from being turned over (Paragraph 0093).
Regarding claim 28, McCllelan in view of Albrecht makes obvious the device of claim 27; yet, does not explicitly disclose wherein the plurality of tabs comprises six tabs, and wherein the six tabs are positioned circumferentially about the posterior portion of the shell at a 12 o'clock position, a 2 o'clock position, a 4 o'clock position, a 6 o'clock position, an 8 o'clock position, and a 10 o'clock position, respectively.
In another embodiment, McClellan teaches that there can be anywhere from 1-10 or greater amounts of tabs and the tabs are evenly spaced about the circumference (Paragraph 0092). If six tabs were used and placed evenly around the circumference as taught by McClellan (Paragraph 0092 expressly states six tabs and that they can be evenly spaced) the first tab would be located at the 6 o’clock position as shown in Fig. 14B, the other tabs would then be located at the 2 o’clock, 4 o’clock, 8 o’clock, 10 o’clock, and 12 o’clock position.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the number and spacing of tabs of McClellan (Figs. 14A-14B) to comprise six tabs which are located at the 12 o’clock, 2 o’clock, 4 o’clock, 6 o’clock, 8 o’clock, and 10 o’clock position, as taught by the other embodiment of McClellan, in order for the device to be sewn into a chest wall to prevent the implant from being turned over (Paragraph 0093).
Regarding claim 29, McCllelan in view of Albrecht makes obvious the device of claim 28, McClellan further discloses wherein the first tab is positioned at the 6 o'clock position (the first tab is positioned at the 6 o’clock position as shown in Fig. 14B).
Claim 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over McClellan in view of Albrecht as applied to claim 22, and further in view of Gerow (US4795463).
Regarding claims 30 and 31, McClellan in view of Albrecht makes obvious the device of claim 22; yet, does not explicitly disclose further comprising an orientation indicator formed along an interior surface of the expandable shell, the orientation indicator comprising a vertical line extending from the injection port, wherein the vertical line extends from the injection port to the first tab.
Gerow teaches a prosthesis for implantation into a breast that is labeled (see Abstract). The label strips (a) as shown in Fig. 1 are applied to the external surface of the envelope of the spheroid prosthesis along the direction of its X and Y axis (see Fig. 1, C7:L10-20; the label strips are interpreted as the claimed orientation indicator comprising a vertical line).
Although Gerow does not explicitly teach the line extending from an injection port to a first tab, the reference line of Gerow is along the major axis (Y axis) on the outer surface. Therefore, when the reference line is applied to the implant of McClellan, the vertical line would extend from the first tab to the injection port, since a line between the first tab and the injection port of McClellan (see Fig. 14B of McClellan) would be along the major axis (Y axis) and because Gerow teaches the vertical line extends along the major axis (Y axis, C7:L10-20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of McClellan/Albrecht to include an orientation indicator comprising a vertical line extending from the injection port to the first tab, as taught by Gerow, for the purpose of allowing a surgeon to align the reference line with a vertical orientation during use to ensure proper orientation of the implant during and/or after implantation (C7:45-50 of Gerow).
The modified invention does not explicitly disclose the orientation indicator formed along an interior surface. However, it would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to have the orientation indicator of the implant of McClellan/Albrecht/Gerow to be formed on an interior surface of the expandable shell, since Applicant has not disclosed that having the orientation indicator formed along an interior of the expandable shell is used for a particular purpose or solves a stated problem. Gerow teaches the labels being radiopaque strips that would be visualized whether external or internal of the implant (C9:L31-34). One of ordinary skill in the art, would have expected the implant of McClellan/Gerow and the claimed invention to perform the same function of orienting the implant with the guidance of the orientation indicator equally well. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant of McClellan/Gerow to have the orientation indicator formed along an interior surface of the expandable shell as a matter of obvious design choice within the level of skill in the art.
Regarding claim 32, McClellan in view of Albrecht and Gerow makes obvious the device of claim 30; yet, does not explicitly disclose wherein, when the expandable shell is viewed from the front, the orientation indicator extends across at least 50% of a vertical dimension of the expandable shell. Gerow further teaches indicator extends across an entirety of a major axis or Y axis (Y axis, C7:L10-20). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified McClellan/Albrecht/Gerow further with Gerow to teach the indicator extending across an entirety of a major axis in order to ensure proper orientation when visualizing the implant (C7:45-50 of Gerow).
Regarding claim 33, McClellan in view of Albrecht and Gerow makes obvious the device of claim 30; yet, does not explicitly disclose wherein the orientation indicator extends across a center position of the expandable shell. Gerow further teaches indicator extends across an entirety of a major axis or Y axis (Y axis, C7:L10-20). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified McClellan/Albrecht/Gerow further with Gerow to teach the indicator extending across an entirety of a major axis in order to ensure proper orientation when visualizing the implant (C7:45-50 of Gerow).
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 MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached on (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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