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 .
Claim Objections
Claim 20 is objected to because of the following informalities: in line 1: “less than basin thickness” should be “less than the basin thickness”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, and 6-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Faries JR et al (US 5879621).
With respect to claim 1, Faries, JR et al ‘621 discloses a drape for a surgical fluid thermal treatment system (Fig 5; drape 51 for the thermal treatment system shown in fig 3) comprising: a flexible sheet (drape 51 is formed of flexible material – col 8 line 66 – col 9 line 2) having a basin portion (Fig 4-5, portions 53 and 52 are adapted to be placed over basins 32 and 33) having a basin perimeter (perimeter defined by basins 32 and 33 as shown in fig 5) and fabricated from a basin polymer composition (the portions at 52 and 53 are part of drape 51 and thus are formed from the material described at col 8 line 66 – col 9 line 2);
a window portion (Fig 4-5, col 8 lines 48-56, the barcode tag 55 is interpreted as being the window portion), fabricated from a window polymer composition different than the basin polymer composition (the bar code tag is a separate material from drape 51 such as paper or cardboard – col 8 lines 5-10); and
a side sheet portion (Fig 4-5, the side sheet portion is interpreted as being the remaining regions of drape 51 that are not the basin portion) extending from the basin portion along at least a part of the basin perimeter (as shown in fig 5);
wherein the basin portion is configured to be positioned in an open basin of a surgical fluid thermal treatment system (as shown in fig 5, portions 53 and 52 are adapted to be placed over basins 32 and 33) and the side sheet portion is configured to cover at least a part of the surgical fluid thermal treatment system (shown in Fig 5).
With respect to claim 3, Faries, JR et al ‘621 discloses the drape as claimed (see rejection of claim 1) and also discloses that the side sheet portion is fabricated from a side sheet polymer composition (drape 51 is formed of flexible material – col 8 line 66 – col 9 line 2) different than the window polymer composition (the bar code tag is a separate material from drape 51 such as paper or cardboard – col 8 lines 5-10).
With respect to claim 6, Faries, JR et al ‘621 discloses the drape as claimed (see rejection of claim 1) and also discloses that the basin portion has a width and a length that is greater than the width (identified in annotated fig 5; the basin portion 53 is rectangularly shaped and thus has a length that is greater than the width), and the window portion (55) projects away from a lengthwise perimeter section of the basin portion (as identified in annotated fig 5).
ANNOTATED Fig 5 of Faries, JR et al:
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With respect to claim 7, Faries, JR et al ‘621 discloses the drape as claimed (see rejection of claim 1) and also discloses that the side sheet portion extends from the basin perimeter at a widthwise perimeter section of the basin portion and from an edge of the window portion in at least a part of the basin lengthwise perimeter section (as shown in fig 5, the drape 51 includes portions extending on all sides around the basin portions 52 and 53).
With respect to claim 8, Faries, JR et al ‘621 discloses the drape as claimed (see rejection of claim 1) and also discloses that the window portion (55) is positioned between the basin portion and the side sheet portion along at least a part of the basin perimeter (as shown in fig 5, the portion 55 is positioned between the basin portions 52 and 53 and the part of drape 51 that extends downwards therefrom over the sides of the system).
With respect to claims 9-11, Faries, JR et al ‘621 discloses the drape as claimed (see rejection of claim 1) and also discloses that the side sheet portion extends from the basin portion in a first basin perimeter section (as shown in the 2nd annotated fig 5); the window portion (55) extends from the basin perimeter in a second basin perimeter section (as shown in the 2nd annotated fig 5, the window 55 extends in a direction away from the part of the perimeter of basin portion 53 identified as the “second” basin perimeter section); and wherein a first edge of the window portion is connected with the basin portion and a second edge of the window portion is connected with the side sheet portion (as shown in the 2nd annotated fig 5, the first edge of window 55 is adjacent to and thus interpreted as being connected with the basin portions 52 and 53 while the second edge is adjacent to and thus interpreted as being connected to the remaining parts of drape 51 that extend downwardly to cover the sides of the system).
2nd ANNOTATED Fig 5 of Faries, JR et al:
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Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 2 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Faries JR et al (US 5879621) in view of Marshall (US 5435322).
With respect to claim 2, Faries, JR et al ‘621 discloses the drape as claimed (see rejection of claim 1) but does not explicitly disclose that the side sheet portion is fabricated from a side sheet polymer composition different than the basin polymer composition.
Marshall, however, teaches a drape comprising a basin portion (12) formed from a heavy gauge polyethylene/ionomer resin blend (col 2 lines 43-44) and a side sheet portion (14) made of a light gauge polyethylene (col 2 lines 55-57). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the drape of Faries having a side sheet portion fabricated from a side sheet polymer composition that is different than the basin polymer composition, as taught by Marshall, in order to provide an area having increased strength for supporting the basin portion of the system.
With respect to claim 4, Faries, JR et al ‘621 discloses the drape as claimed (see rejection of claim 1) and Faries also discloses that the window portion (barcode tag 55) is fabricated from a window polymer composition different than the basin polymer composition and the side sheet polymer composition (the bar code tag is a separate material from drape 51 such as paper or cardboard – col 8 lines 5-10 whereas the side sheet is formed from polyurethane – see col 9 lines 5-7). Faries does not, however, explicitly disclose that the side sheet portion is fabricated from a side sheet polymer composition different than the basin polymer composition.
Marshall, however, teaches a drape comprising a basin portion (12) formed from a heavy gauge polyethylene/ionomer resin blend (col 2 lines 43-44) and a side sheet portion (14) made of a light gauge polyethylene (col 2 lines 55-57). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the drape of Faries having a side sheet portion fabricated from a side sheet polymer composition that is different than the basin polymer composition, as taught by Marshall, in order to provide an area having increased strength for supporting the basin portion of the system.
With respect to claim 5, Faries, JR et al ‘621 in view of Marshall discloses the drape substantially as claimed (see rejection of claim 4) and Faries also discloses that the side sheet polymer composition comprises polyurethane (col 9 lines 5-7).
Claim(s) 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Faries JR et al (US 5879621) in view of Houde et al (US 2014/0041669).
With respect to claim 12, Faries, JR et al ‘621 discloses a drape for a surgical fluid thermal treatment system (Fig 5; drape 51 for the thermal treatment system shown in fig 3) comprising: a flexible sheet (drape 51 is formed of flexible material – col 8 line 66 – col 9 line 2) having a basin portion (Fig 4-5, portions 53 and 52 are adapted to be placed over basins 32 and 33) having a basin perimeter (perimeter defined by basins 32 and 33 as shown in fig 5) and fabricated from a basin polymer composition (the portions at 52 and 53 are part of drape 51 and thus are formed from the material described at col 8 line 66 – col 9 line 2);
a window portion (Fig 4-5, col 8 lines 48-56, the barcode tag 55 is interpreted as being the window portion), fabricated from a window polymer composition (the bar code tag is a separate material from drape 51 such as paper or cardboard – col 8 lines 5-10); and
a side sheet portion fabricated from a side sheet polymer composition (Fig 4-5, the side sheet portion is interpreted as being the remaining regions of drape 51 that are not the basin portion and thus is formed from the material of drape 51) extending from the basin portion along at least a part of the basin perimeter (as shown in fig 5);
wherein the basin portion is configured to be positioned in an open basin of a surgical fluid thermal treatment system (as shown in fig 5, portions 53 and 52 are adapted to be placed over basins 32 and 33) and the side sheet portion is configured to cover at least a part of the surgical fluid thermal treatment system (shown in Fig 5).
Faries does not, however, disclose that the window polymer composition comprises a tackifying agent.
Houde, however, teaches a medical drape formed from a polymer material that includes tackifying agents to provide a high coefficient of friction (para [0031]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used a polymer composition that comprises a tackifying agent, as taught by Houde, for the window polymer composition of the window portion in Faries, in order to provide a high coefficient of friction at the window portion.
With respect to claim 13, Faries, JR et al ‘621 in view of Houde discloses the drape substantially as claimed (see rejection of claim 12) and Faries further discloses that the window portion overlays a user interface of the surgical fluid thermal treatment system when the drape is positioned over the surgical fluid thermal treatment system (Bar code tag 55 is manipulated such that the bar code tag is positioned over bar code reader socket 39; see fig 3 and col 8 lines 62-65).
With respect to claims 14-15, Faries, JR et al ‘621 in view of Houde discloses the drape substantially as claimed (see rejection of claim 13) wherein the medical drape is formed from a polymer material that includes tackifying agents to provide a high coefficient of friction (Houde para [0031]; see rejection of claim 13). Additionally, modification of the device of Faries to form the window portion (bar code tag 55) from a polymer composition that comprises a tackifying agent to provide a high coefficient of friction, as taught by Houde (see rejection of claim 13), inherently will result in an increase in friction between the bar code tag 55 and the bar code reader socket 39 that it is positioned over during use (see col 8 lines 62-65) wherein the increased friction inherently will provide a resistance to movement of the bar code tag relative to the underlying bar code reader socket. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used a polymer composition that comprises a tackifying agent, as taught by Houde, for the window polymer composition of the window portion in Faries, in order to provide a high coefficient of friction at the window portion that inherently increases friction between the window portion and the user interface wherein the increased friction between the window portion and the user interface resists movement of the window portion relative to the user interface in order to maintain the drape in the proper position on the system during use.
With respect to claim 16, Faries, JR et al ‘621 in view of Houde discloses the drape substantially as claimed (see rejection of claim 12) and Faries further discloses that the window polymer composition differs from the basin polymer composition (the bar code tag is a separate material from drape 51 such as paper or cardboard – col 8 lines 5-10).
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Faries JR et al (US 5879621) in view of Giles et al (US 2012/0298117), Sklar (WO 01/97866 A2) and Marshall (US 5435322).
With respect to claims 17-20, Faries, JR et al ‘621 discloses a drape for a surgical fluid thermal treatment system (Fig 5; drape 51 for the thermal treatment system shown in fig 3) comprising: a flexible sheet (drape 51 is formed of flexible material – col 8 line 66 – col 9 line 2) having a basin portion (Fig 4-5, portions 53 and 52 are adapted to be placed over basins 32 and 33) having a basin perimeter (perimeter defined by basins 32 and 33 as shown in fig 5) and fabricated from a basin polymer composition (the portions at 52 and 53 are part of drape 51 and thus are formed from the material described at col 8 line 66 – col 9 line 2);
a window portion (Fig 4-5, col 8 lines 48-56, the barcode tag 55 is interpreted as being the window portion), fabricated from a window polymer composition different than the basin polymer composition (the bar code tag is a separate material from drape 51 such as paper or cardboard – col 8 lines 5-10); and
a side sheet portion (Fig 4-5, the side sheet portion is interpreted as being the remaining regions of drape 51 that are not the basin portion) extending from the basin portion along at least a part of the basin perimeter (as shown in fig 5);
wherein the basin portion is configured to be positioned in an open basin of a surgical fluid thermal treatment system (as shown in fig 5, portions 53 and 52 are adapted to be placed over basins 32 and 33) and the side sheet portion is configured to cover at least a part of the surgical fluid thermal treatment system (shown in Fig 5).
Faries also discloses that the basin material, window material, and side sheet material each have a thickness (inherent material property) but does not disclose that the window thickness is different from the basin thickness and the side sheet thickness is different from the window thickness such that, specifically, the window thickness is less than a thickness of the basin portion and less than the side sheet thickness.
Giles teaches a medical drape wherein, specifically, the drape has a thickness between 0.011 and 0.013 inches (converts to approx. 11-13 mils; see claim 20).
Sklar teaches a drape having a window formed of a high transparency polymer, and is preferably of a thickness that allows transmission of tactile pressure, enabling touch-screen data entry through the drape wherein a thickness of five mils is considered suitable to reliably transmit the monitor image with extreme clarity and permit touch screen use of the monitor while maintaining a sterile field for the surgeon (pg 2 lines 5-7 and pg 4 lines 8-15).
Marshall teaches a drape configured with a portion that has a thickness of between 10-16 mils to support a basin on a stand (see col 2 lines 40-54).
Modification of the drape of Faries to include a side sheet having a thickness of between 11-13 mils (as taught by Giles), a window having a thickness of 5 mils (as taught by Sklar) and a basin portion having a thickness of 10-16 mils (as taught by Marshall) would result in a structure wherein the window thickness (5mils) is different from the basin thickness (10-16mils), the side sheet thickness (11-13mils) is different from the window thickness (5mils), and, specifically, the window thickness (5mils) is less than a thickness of the basin portion (10-16mils) and less than the side sheet thickness (11-13mils). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the drape of Faries so that the side sheet portion has a thickness between 11-13 mils, like the drape of Giles, the window portion has a thickness of 5 mils, as taught by Sklar, and the basin portion has a thickness of 10-16 mils, as taught by Marshall, since each modification would have involved a mere change in the size of a component which is generally recognized as being within the level of ordinary skill in the art.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-5 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-8 of U.S. Patent No. 11,730,555 (“Hendrix”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are a broader recitation of the invention than that of the patented application. Specifically, although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 of the present application and claims 1 and 6 of Hendrix differ in that the patented claims include more elements than the claims in the present application and, therefore, are more narrow and specific. Thus, claims 1 and 6 of Hendrix are in effect a “species” of the broader, “generic” invention recited in claim 1 of the present application. It has been held that a generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Thus, claim 1 of the present application is anticipated by claims 1 and 6 of Hendrix and, therefore, is not patentably distinct from claims 1 and 6 of Hendrix.
Additionally, with respect to claim 12, although the conflicting claims are not identical, they are not patentably distinct from each other because claim 12 of the present application and claims 1 and 8 of Hendrix differ in that the patented claims include more elements than the claims in the present application and, therefore, are more narrow and specific. Thus, claims 1 and 8 of Hendrix are in effect a “species” of the broader, “generic” invention recited in claim 12 of the present application. It has been held that a generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Thus, claim 12 of the present application is anticipated by claims 1 and 8 of Hendrix and, therefore, is not patentably distinct from claims 1 and 8 of Hendrix.
All of the limitations of claims 2-5 can be found in claims 6-7 of Hendrix.
Claims 1, 6, 8, 12, 17 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-11, 14 and 17 of U.S. Patent No. 12310692 (“Hendrix ‘692”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are a broader recitation of the invention than that of the patented application.
Specifically, with respect to claim 1 of the present application, although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 of the present application and claim 1 of Hendrix ‘692 differ in that the patented claims include more elements than the claims in the present application and, therefore, are more narrow and specific. Thus, claim 1 of Hendrix ‘692 is in effect a “species” of the broader, “generic” invention recited in claim 1 of the present application. It has been held that a generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Thus, claim 1 of the present application is anticipated by claim 1 of Hendrix ‘692 and, therefore, is not patentably distinct from claim 1 of Hendrix ‘692.
All of the limitations of claims 6 and 8 can be found in claims 10 and 17 of Hendrix ‘692.
With respect to claim 12 of the present application, although the conflicting claims are not identical, they are not patentably distinct from each other because claim 12 of the present application and claims 1 and 14 of Hendrix ‘692 differ in that the patented claims include more elements than the claims in the present application and, therefore, are more narrow and specific. Thus, claims 1 and 14 of Hendrix ‘692 are in effect a “species” of the broader, “generic” invention recited in claim 12 of the present application. It has been held that a generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Thus, claim 12 of the present application is anticipated by claims 1 and 14 of Hendrix ‘692 and, therefore, is not patentably distinct from claims 1 and 14 of Hendrix ‘692.
With respect to claim 17 of the present application, although the conflicting claims are not identical, they are not patentably distinct from each other because claim 17 of the present application and claims 1 and 11 of Hendrix ‘692 differ in that the patented claims include more elements than the claims in the present application and, therefore, are more narrow and specific. Thus, claims 1 and 11 of Hendrix ‘692 are in effect a “species” of the broader, “generic” invention recited in claim 17 of the present application. It has been held that a generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Thus, claim 17 of the present application is anticipated by claims 1 and 11 of Hendrix ‘692 and, therefore, is not patentably distinct from claims 1 and 11 of Hendrix ‘692.
All of the limitations of claim 20 can be found in claim 11 of Hendrix ‘692.
Conclusion
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786
