DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant argues in the response filed 01/28/2026 that the amendments would overcome the claim objections and 112 rejections. The objections and 112 rejections have been withdrawn.
The applicant argues they traverse the double patenting rejections however would consider filing a terminal disclaimer to obviate the rejections once the claims are otherwise in condition for allowance. It is to be noted there as no specific arguments with respect to the double patenting rejections. The examiner knowledges the statement, but the rejections are maintained below.
The applicant argues figure 3c of Maiorino appears to show a through hole of the suture and not a flat cross cross-section. Therefore the prior art wouldn’t be able to read on the claims of record. The examiner disagrees. Maiorino discloses in paragraph 17 that figures 3a-I are the cross-sectional geometry of the elongated flexible member 20, which reads on the suture. Further the surface features 14 are a part of the cross-section. The surface features can fold/flex as the suture is drawn into tissue, which can read on the claim limitations. It is to be noted that claims were amended with respect the folding a portion of the cross section over on itself “as it is drawn into” ophthalmic tissue. Alcamo and Morency can further teach/provide evidence that barbs will flex/fold on itself as the suture is drawn into tissue. Further limitations with respect to how the portion will fold on itself, with support, is needed to overcome the prior art of record. Alternatively, further limitations with respect to the transparent portion can help to overcome the prior art of record.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Publication 2008/0132943 to Maiorino in view of U.S. Patent 4,327,450 to Girard and in view of or as evidenced by U.S. Patent 3,123,077 to Alcamo.
As to claim 2, Maiorino discloses a method comprising inserting a suture through opposing sides of a wound (figure 5-7, paragraph 19, 22), the suture includes a flat cross section (figure 3c), folding a portion (14, or the general section of the suture as it enters the wound and makes it way around the wound) of the flat cross section (figure 3c) over on itself as it is drawn into ophthalmic tissue (figure 4-6, paragraph 22, the surface feature will fold/flex down as it is drawn in to tissue), tightening the suture within the tissue to close the wound (paragraph 19,22, figure 5-7), wherein the folding and the flat cross section provide increased friction to the suture to increase pull out resistance (paragraph 17, 19, 22). Maiorino discloses the suture can have a flat cross section (figure 3c) that includes the barbs (the barbs can fold down). The barbs can fold down, which will mean the barbs fold down on the (flat cross section) suture itself. The barbs increase friction since the surface of the suture is not smooth. The fact that the suture can flex to read on a fold, lock itself, has barbs, the barbs can fold down, the suture has a flat cross section, the suture can have the function of having increased friction to increase pull out resistance.
If it would not be known that the barbs, which a portion of the flat cross section since the barbs on the flat suture of figure 3c, will fold on itself as it is drawn into tissue, Alcamo teaches a similar device (suture) that teaches barbs which fold on itself as it drawn into tissue (figure 3-7, col. 2 ll. 2-24) for the purpose of flexing as it passed through tissue but preventing slippage in the other direction. Alcamo provides evidence, or teaches, that flexible barbs will flex, or fold, on itself as it is drawn into tissue, and the barbs do increase friction. It would have been obvious to one of ordinary skill in the art before the effective filing date to have a portion of the flat cross section of the suture of Maiorino, specifically the barbs, fold over on itself as it is drawn into tissue in order for flexing as it passed through tissue but preventing slippage in the other direction.
Maiorino discloses the wound closure device can be used for all wound closure techniques (paragraph 36) however is specifically silent about the wound is an ophthalmic wound.
Girard teaches a similar method (ophthalmic methods, abstract) comprising inserting a suture (18) through opposing sides of an ophthalmic wound (figure 4, col. 2 ll. 25-48), tightening the suture within the ophthalmic tissue to close the ophthalmic wound (col. 2 ll. 25-48) for the purpose of using sutures to close a wound in the eye. Maiorino discloses the method can be used for all wound closure techniques. Girard teaches that it is known that sutures can be used to close ophthalmic wounds. Therefore the suture method of Maiorino can be used on the eye. Further, Girard can teach an alternative interpretation that when a suture is inserted into tissue, it will fold over a portion of the suture as seen in figure 4, in order to loop around the wound, to close the incision. The portion of the suture that is drawn into tissue will fold over the portion of the suture that is above the wound. The suture of Maiorino used in the ophthalmic wound closure method of Girard will fold over a portion of the suture since it is drawn into the tissue. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the method of Maiorino to close an ophthalmic wound as taught by Girard in order to close a wound in the eye.
Claims 2, 5, 6, 8-10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent 5,021,057 to Byrne in view of U.S. Patent Publication 2008/0132943 to Maiorino and/or U.S. Patent 2003/0149447 to Morency.
As to claim 2, Byrne discloses a method inserting a suture ophthalmic wound (col. 2 ll. 35-39, col. 5 ll. 10-23), but is silent about the suture includes a flat cross section, inserting a suture through opposing sides of the wound, the suture includes a flat cross section, folding a portion of the flat cross section over on itself as it is drawn into ophthalmic tissue, tightening the suture within the ophthalmic tissue to close the ophthalmic wound, wherein the folding and the flat cross section provide increased friction to the suture to increase pull out resistance.
Maiorino teaches a similar method (wound closure) including using a suture with a flat cross section (figure 3c), folding a portion (14) of the flat cross section (figure 3c) over on itself as it is drawn into ophthalmic tissue (figure 4-6, paragraph 22, the barbs will flex, or fold down on the suture as it is drawn into tissue), wherein the folding and the flat cross section provide increased friction to the suture to increase pull out resistance (paragraph 17, 19, 22) for the purpose of securing the device in place as the wound is closed. Maiorino teaches the suture can have a flat cross section (figure 3c) that includes the barbs (the barbs can fold fold). The barbs can fold down, which will mean the barbs fold down on the (flat cross section) suture itself. The fact that the suture can flex to read on a fold, lock itself, has barbs, the barbs can fold down, the suture has a flat cross section, the suture can have the function of having increased friction to increase pull out resistance.
Morency also teaches a similar method (suturing, abstract) including using a suture with a flat cross section (figure 1b, paragraph 33), folding a portion (24) of the flat cross section (figure 1b) over on itself as it is drawn into ophthalmic tissue (paragraph 38, the barbs will flex inward, or fold down as it is drawn into tissue), wherein the folding and the flat cross section provide increased friction to the suture to increase pull out resistance (paragraph 33, 38, having barbs will increase friction) for the purpose of making the suture easier to manufacture form a flat stock material and allowing the suture to resist rearward motion. Morency teaches suture can have a flat profile as shown in figure 1b and the barbs will flex or fold as it is drawn into tissue. The barbs increase friction since the suture isn’t smooth. Morency can provide evidence on Maiorino that the barbs will flex/fold as they are drawn into tissue.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have the suture used in the method of Byrne include a flat cross section, and the steps of folding a portion of the flat cross section over on itself within the ophthalmic tissue, wherein the folding and the flat cross section provide increased friction to the suture to increase pullout resistance in order for using an easy to manufacture suture that secure the suture in place by resisting rearward motion.
As to claim 5, with the method of Byrne and Maiorino/Morency above, Byrne discloses pressing a transparent portion (10, col. 4 ll. 36-38) of a visualization device in direct contact with an ophthalmic wound prior to inserting the suture (col. 4 ll. 31-35, col. 5 ll. 20-28). The device presses a wound, rotates, then apply more sutures. Therefore, the transparent portion presses the wound before at least the additional sutures are applied.
As to claim 6, with the method of Byrne and Maiorino/Morency above, Byrne discloses inserting the suture through opposing sides of the ophthalmic wound includes suturing the ophthalmic wound at an edge (23) of the transparent portion while maintaining pressure of the transparent portion against the ophthalmic wound (col. 4 ll. 31-35, col. 5 ll. 20-28).
As to claim 8, with the method of Byrne and Maiorino/Morency above, Byrne discloses, the transparent portion of the visualization device includes holding a handle (figure 9) attached to the transparent portion and applying pressure with the handle (col. 4 ll. 31-35, col. 5 ll. 20-28).
As to claims 9, 10, with the method of Byrne and Maiorino/Morency above, Byrne discloses suturing the suturing the ophthalmic wound at an edge (23) of the transparent portion includes suturing the wound at an access region in the transparent portion (region of opening of 23).
Claims 3, 4 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Publication 2008/0132943 to Maiorino in view of U.S. Patent 4,327,450 to Girard and in view of or as evidenced by U.S. Patent 3,123,077 to Alcamo as applied to claim 2 above, and further in view of U.S. Patent Publication 2008/0255612 to Hunter.
As to claim 3, Maiorino as modified by Girard, and Alcamo discloses the method above but is silent about flat cross section includes a pattern pressed into a side of the sutures.
Hunter teaches a similar method (suturing, abstract) including a pattern pressed into a side of the suture (paragraph 101) for the purpose of using a known way to manufacture the suture to enhance the suture qualities. Hunter discloses the suture can be shaped by stamping. The suture of Hunter has tissue retainers that can made by stamping which can read on pressing the suture. The surface features of Maiorino and/or of Hunter can be the pattern. It would have been obvious to one of ordinary skill in the art before the effective filing date for the method of Maiorino and Girard have the flat cross section including a pattern pressed into a side of the suture for the purpose of using a known way to manufacture the suture to enhance the suture qualities.
As to claim 4, with the method of Maiorino and Girard, Alcamo above, Maiorino discloses the flat cross section has knurls (paragraph 18). Maiorino does disclose that the surface features can be barbs, hooks, latches, protrusions, leaves, teeth and/or combinations thereof. If the surface features of Maiorino wouldn’t be able to read knurls, Hunter teaches a similar method (the suturing) having surface features that can encompass, without limitation, surfaces that are rippled, corrugated, rough, dimpled, serrated, knobby, ridged, filamented, concave, convex, and so forth for the purpose of using increased surface area shape to help retain the suture in place. The surface features of Hunter can render obvious the use of knurls. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the method of be Maiorino and Girard comprise a suture with flat section including knurls in order for using increased surface area shape to help retain the suture in place.
Claim 3, 4 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent 5,021,057 to Byrne in view of U.S. Patent Publication 2008/0132943 to Maiorino and/or U.S. Patent 2003/0149447 to Morency as applied to claims 2, 5, 6, 8-10 above, and further in view of U.S. Patent Publication 2008/0255612 to Hunter.
As to claim 3, Byrne as modified by Maiorino/Morency discloses the method above but is silent about flat cross section includes a pattern pressed into a side of the sutures.
Hunter teaches a similar method (suturing, abstract) including a pattern pressed into a side of the suture (paragraph 101) for the purpose of using a known way to manufacture the suture to enhance the suture qualities. Hunter discloses the suture can be shaped by stamping. The suture of Hunter has tissue retainers that can made by stamping which can read on pressing the suture. The surface features of Maiorino and/or of Hunter can be the pattern. It would have been obvious to one of ordinary skill in the art before the effective filing date for the method of Byrne and Maiorino have the flat cross section including a pattern pressed into a side of the suture for the purpose of using a known way to manufacture the suture to enhance the suture qualities.
As to claim 4, with the method of Byrne and Maiorino/Morency above, Maiorino further teaches the flat cross section has knurls (paragraph 18). Maiorino does teach that the surface features can be barbs, hooks, latches, protrusions, leaves, teeth and/or combinations thereof. If the surface features of Maiorino wouldn’t be able to read knurls, Hunter teaches a similar method (the suturing) having surface features that can encompass, without limitation, surfaces that are rippled, corrugated, rough, dimpled, serrated, knobby, ridged, filamented, concave, convex, and so forth for the purpose of using increased surface area shape to help retain the suture in place. The surface features of Hunter can render obvious the use of Knurls. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the method of be Byrne and Maiorino/Morency comprise a suture with flat section including knurls in order for using increased surface area shape to help retain the suture in place.
Claim 7 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent 5,021,057 to Byrne in view of U.S. Patent Publication 2008/0132943 to Maiorino and/or U.S. Patent 2003/049447 to Morency as applied to claims 2, 5, 6, 8-10 above, and further in view of U.S. Patent Publication 2008/0091224 to Griffis.
As to claim 7, Byrne as modified by Maiorino discloses the method above but is silent about engaging one or more frictional protrusions located on one side of the transparent portion with an eye to hold the transparent portion in place while suturing.
Griffis teaches a similar method including engaging one or more frictional protrusions (210) located on one side of the transparent portion with an eye to hold the transparent portion in place and engaging one or more teeth (paragraph 72) for the purpose allowing the device to be better attached to the eye. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the one or more frictional protrusions of Griffis with the device in the method of Byrne and Maiorino/Morency in order for allowing the device to be better attached to the eye.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 2, 3, 5-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,918,377 in view of U.S. Patent Publication 2008/0132943 to Maiorino and in view of or as evidenced by U.S. Patent 3,123,077 to Alcamo.
As to the application’s claim 2, the reference patent is directed to a method (claim 1,10), comprising; inserting a suture (claim 1,10) through wound, but is silent about the suture is inserted through opposing sides of the wound, wherein the suture includes a flat cross section; folding a portion of the flat cross section over on itself as it is drawn into ophthalmic tissue; tightening the suture within the ophthalmic tissue to close the ophthalmic wound, wherein the folding and the flat cross section provide increased friction to the suture to increase pullout resistance
Maiorino teaches a similar method (wound closure) including using inserting a suture (10) through opposing sides of a wound (figure 5-7), the suture with a flat cross section (figure 3c), folding a portion (14) of the flat cross section (figure 3c) over on itself as it is drawn into the ophthalmic tissue (figure 4-6, paragraph 22), wherein the folding and the flat cross section provide increased friction to the suture to increase pull out resistance (paragraph 17, 19, 22) for the purpose of securing the device in place as the wound is closed. Maiorino teaches the suture can have a flat cross section (figure 3c) that includes the barbs. The barbs can fold down, which will mean the barbs fold down on the (flat cross section) suture itself. Alcamo can provide evidence that the barbs will fold on itself when it is drawn into tissue (figure 3-7). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the suture used in the method of reference patent include a flat cross section, and the steps inserting the suture through opposing sides of the wound, folding a portion of the flat cross section over on itself within the ophthalmic tissue, wherein the folding and the flat cross section provide increased friction to the suture to increase pullout resistance in order for helping to securing the suture in place to close the wound.
As to the application’s claim 3, see reference patent claim 7.
As to the application’s claim 5, see reference patent claim 1, 10.
As to the application’s claim 6, see reference patent claim 1, 10.
As to the application’s claim 7, see reference patent claim 4.
As to the application’s claim 8, see reference patent claim 5.
As to the application’s claim 9, 10, see reference patent claim 1, 10
As to the application’s claim 11, see reference patent claim 1, 10 (the thinner middle region can read on the hourglass).
Claims 2, 3, 5-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,042,142 in view of U.S. Patent Publication 2008/0132943 to Maiorino and in view of or as evidenced by U.S. Patent 3,123,077 to Alcamo.
As to the application’s claim 2, the reference patent is directed to a method (claim 1), comprising; inserting a suture (claim 1) through wound, but is silent about the suture is inserted through opposing sides of the wound, wherein the suture includes a flat cross section; folding a portion of the flat cross section over on itself within the ophthalmic tissue; tightening the suture within the ophthalmic tissue to close the ophthalmic wound, wherein the folding and the flat cross section provide increased friction to the suture to increase pullout resistance
Maiorino teaches a similar method (wound closure) including using inserting a suture (10) through opposing sides of a wound (figure 5-7), the suture with a flat cross section (figure 3c), folding a portion (14) of the flat cross section (figure 3c) over on itself as it is drawn into ophthalmic tissue (figure 4-6, paragraph 22), wherein the folding and the flat cross section provide increased friction to the suture to increase pull out resistance (paragraph 17, 19, 22) for the purpose of securing the device in place as the wound is closed. Maiorino teaches the suture can have a flat cross section (figure 3c) that includes the barbs. Alcamo can provide evidence that the barbs will fold on itself when it is drawn into tissue (figure 3-7). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the suture used in the method of reference patent include a flat cross section, and the steps inserting the suture through opposing sides of the wound, folding a portion of the flat cross section over on itself within the ophthalmic tissue, wherein the folding and the flat cross section provide increased friction to the suture to increase pullout resistance in order for helping to securing the suture in place to close the wound.
As to the application’s claim 3, see reference patent claim 6, 7.
As to the application’s claim 5, see reference patent claim 1.
As to the application’s claim 6, see reference patent claim 1.
As to the application’s claim 7, see reference patent claim 2.
As to the application’s claim 8, see reference patent claim 4.
As to the application’s claim 9, 10, see reference patent claim 1.
As to the application’s claim 11, see reference patent claim 10.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,918,377 in view of U.S. Patent Publication 2008/0132943 to Maiorino and in view of or as evidenced by U.S. Patent 3,123,077 to Alcamo as applied to claims 2, 3, 5-11 above, and further in view of U.S. Patent Publication 2008/0255612 to Hunter.
As to the application’s claim 4, with the method of the reference patent as modified by Maiorino/Alcamo above, Maiorino further teaches the flat cross section has knurls (paragraph 18). Maiorino does teach that the surface features can be barbs, hooks, latches, protrusions, leaves, teeth and/or combinations thereof. If the surface features of Maiorino wouldn’t be able to read knurls, Hunter teaches a similar method (the suturing) having surface features that can encompass, without limitation, surfaces that are rippled, corrugated, rough, dimpled, serrated, knobby, ridged, filamented, concave, convex, and so forth for the purpose of using increased surface area shape to help retain the suture in place. The surface features of Hunter can render obvious the use of Knurls. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the method of be Byrne and Maiorino comprise a suture with flat section including knurls in order for using increased surface area shape to help retain the suture in place.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,042,142 in view of U.S. Patent Publication 2008/0132943 to Maiorino and in view of or as evidenced by U.S. Patent 3,123,077 to Alcamo as applied to claims 2, 3, 5-11 above, and further in view of U.S. Patent Publication 2008/0255612 to Hunter.
As to the application’s claim 4, with the method of the reference patent as modified by Maiorino/Alcamo above, Maiorino further teaches the flat cross section has knurls (paragraph 18). Maiorino does teach that the surface features can be barbs, hooks, latches, protrusions, leaves, teeth and/or combinations thereof. If the surface features of Maiorino wouldn’t be able to read knurls, Hunter teaches a similar method (the suturing) having surface features that can encompass, without limitation, surfaces that are rippled, corrugated, rough, dimpled, serrated, knobby, ridged, filamented, concave, convex, and so forth for the purpose of using increased surface area shape to help retain the suture in place. The surface features of Hunter can render obvious the use of Knurls. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the method of be Byrne and Maiorino comprise a suture with flat section including knurls in order for using increased surface area shape to help retain the suture in place.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Publication 2005/0277985 to Wert, U.S. Patent Publication 2007/0027475 to Pagedas, U.S. Patent Publication 2011/0276090 to Berndt, U.S. Patent Publication 2014/0213966 to Ostapoff, and U.S. Patent Publication 2018/0000480 all disclose similar devices and method pertinent to the scope of the claims.
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).
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 ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached on Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771