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
Claims 1, 7 and 10 are objected to because of the following informalities which require appropriate correction:
In claim 1 line 4: “a user’s penis” should be amended to recite “a penis of a user”.
In claim 1 line 5: “with movable clamp arm” should be “with the movable clamp arm”.
In claim 7 line 1: “concaved” should be “concave”.
In claim 10 line 2: “a user’s penis” should be amended to recite “a penis of a user”.
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.
Claims 1 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bialick (US 3203421).
With respect to claim 1, Bialick discloses an incontinence clamp (clamp device 10) and a removable compression element (pressure exerting means such as element 23 which is interpreted as being “removable” because the element 23 is "adjustably" mounted by guide pins 25 which move through apertures 26 on arm 11 and thus are interpreted as being capable of permitting removal of the pressure exerting means – see col 2 lines 40-43) for the incontinence clamp (shown in fig 1 on the device 10) comprising: a guide (element 23) dimensioned to span a majority of an inner surface of a movable clamp arm of the incontinence clamp (as shown in fig 1, element 23 covers at least half of the inner surface of arm 11 and thus is interpreted as spanning a "majority" of the inner surface), the movable clamp arm (11) dimensioned to partially encircle a user's penis (as shown in fig 1), the guide (23) comprising a curved concave-inner surface (the surface that faces the user's body member within the clamp as shown in figure 1 is curved and is a concave face 24), a convex outer surface (the surface that faces element 31 in figure 1 has a convex shape), and a connector for coupling with movable clamp arm (element 23 is mounted on arm 11 by guide pins 25 – col 2 lines 41-43), and a padding attached to cover the guide (sheath portion 33 that is formed of rubber and encases element 23 – col 2 lines 52-69; fig 1; rubber material is interpreted as providing a padded surface), exclusive of the connector (the sheath portion 33 is structurally independent of the guide pins 25 as shown in fig 1).
With respect to claim 8, Bialick discloses the device as claimed (see rejection of claim 1) and Bialick also discloses that the connector (pins 25) comprises a plurality of connecting positions, wherein each of the connecting positions couples with the movable clamp arm (col 2 lines 40-51; element 23 is moved by jack screw 27 which is rotatably engaged in the body of element 23 and the element 23 is moved towards or away from arm 11 guided by pins 25 and thus includes multiple positions along each pin 25 where element 23 is connected during adjustment while remaining coupled to arm 11 via the pins 25 – see also figures 1, 3 and 5 which show the element 23 at various different positions along the pins 25 while the pins still couple the element 23 to the arm 11).
With respect to claim 9, Bialick discloses an incontinence clamp (clamp device 10) and a compression element (pressure exerting means such as element 23) for the incontinence clamp (shown in fig 1 on the device 10) comprising: a removable guide (element 23; interpreted as being “removable” because the element 23 is "adjustably" mounted by guide pins 25 which move through apertures 26 on arm 11 and thus are interpreted as being capable of permitting removal of the element – see col 2 lines 40-43) configured to releasably couple with an arcuate clamp arm of the incontinence clamp (element 23 is "adjustably" mounted by guide pins 25 which move through apertures 26 on arm 11 and thus is interpreted as being capable of permitting removal of the element 23 from arm 11 – see col 2 lines 40-43; as shown in fig 1, the arm 11 includes a bent or curved portion 11a thus giving it an “arcuate” shape), the removable guide having a convex outer face (the surface that faces element 31 in figure 1 has a convex shape) that underlies a majority of a concave inner surface of the arcuate clamp arm (as shown in fig 1, the surface of arm 11, including portion 11a, which faces the body member during use is curved inwardly and thus has a concave shape; also as shown in fig 1, the surface of element 23 that faces element 31 underlies at least half of the inner surface of arm 11 and thus is interpreted as underlying a "majority" of the inner surface), the removable guide (23) comprising a concave inner face (the surface that faces the user's body member within the clamp as shown in figure 1 is curved and is a concave face 24), and a padding that surrounds a majority of the removable guide between the convex outer face and the concave inner face (sheath portion 33 that is formed of rubber and encases element 23 – col 2 lines 52-69; fig 1; rubber material is interpreted as providing a padded surface).
With respect to claim 10, Bialick discloses the device as claimed (see rejection of claim 9) and Bialick also discloses that the removable guide is dimensioned to selectively adjust a size of the incontinence clamp to a user's penis (element 23 is moved by jack screw 27 which is rotatably engaged in the body of element 23 and functions such that the element 23 is moved towards or away from arm 11 guided by pins 25 to thereby adjust size – see col 1 lines 31-35, 45-48; col 2 lines 40-51; col 3 lines 47-54).
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.
Claims 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Bialick (US 3203421) in view of Rennich (US 2005/0085835).
With respect to claim 2, Bialick discloses the device as claimed (see rejection of claim 1) but does not explicitly disclose that the padding is releasably secured over the guide.
Rennich teaches an analogous clamp that includes a pad 40 for increasing wearing comfort and a removable sleeve 42 that is provided for covering the pad 40 to prevent soiling thereof (para [0034]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the sheath portion 33 of Bialick so that it is releasably secured over element 23, like the sleeve 42 that removably covers pad 40 in Rennich, is order to protect the element 23 and prevent soiling of the element.
With respect to claim 11, Bialick discloses the device as claimed (see rejection of claim 1) but does not explicitly disclose that the padding is releasably secured over the removable guide.
Rennich teaches an analogous clamp that includes a pad 40 for increasing wearing comfort and a removable sleeve 42 that is provided for covering the pad 40 to prevent soiling thereof (para [0034]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the sheath portion 33 of Bialick so that it is releasably secured over element 23, like the sleeve 42 that removably covers pad 40 in Rennich, is order to protect the element 23 and prevent soiling of the element.
Claims 3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Bialick (US 3203421) in view of Rennich (US 2005/0085835) and further in view of Garcia Berruezo (US 2014/0041672).
With respect to claims 3 and 12, Bialick in view of Rennich discloses the device substantially as claimed (see rejections of claims 2 and 11) and Bialick discloses that the sheath portion 33 is formed of rubber or any synthetic plastic material having moisture impervious and elastic characteristics (see col 2 lines 52-69) but does not explicitly disclose that the padding is formed of a thermoplastic elastomer.
Garcia Berruezo teaches a device for urinary incontinence which includes a flexible metal structure coated by injection of thermoplastic or silicone rubber (para [0014]; thermoplastic rubber is a thermoplastic elastomer). 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 thermoplastic rubber as taught by Garcia Berruezo as the rubber of the padding on the device of Bialick in view of Rennich in order to provide a soft, flexible material which is still durable and tough (as these are inherent characteristics of thermoplastic rubber) and, furthermore, because it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Claims 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Bialick (US 3203421) in view of Rennich (US 2005/0085835) and further in view of Johnson (US 5842968).
With respect to claim 4, Bialick in view of Rennich discloses the device substantially as claimed (see rejection of claim 2) but does not disclose that the padding comprises a plurality of ridges formed on an outer surface.
Johnson, however, teaches an analogous clamp device used for treating male urinary
incontinence (abstract; col 2 lines 24-30) wherein the device includes a cushion 12 having a
plurality of ridges formed on an outer surface (key ridge portion 1 attached to the inside
surface of straps 5 and 6 - shown in figures 1-2; and including high portions 2 through which
notches 3 are formed which notches close up when the device is wrapped around the penis - col 3 lines 3-6; key ridge portion 1 and high portions 2 are interpreted as providing a plurality of
ridges on the outer surface of the cushion 12) and wherein the ridges (key ridge 1) are adapted
to be in contact with a user's body during use (as shown in figure 5 - col 3 lines14-16) and are
compressed to close off the flow of urine from the bladder through the urethra (col 3 lines 35-
39). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the padding on the device of Bialick in view of Rennich to include a plurality of ridges on an outer surface of the padding as taught by Johnson in order to provide flexibility for wrapping the device around the penis and furthermore to provide areas configured to be compressed to close off the flow of urine from the bladder through the urethra as taught by Johnson.
With respect to claim 13, Bialick in view of Rennich discloses the device substantially as claimed (see rejection of claim 11) but does not disclose that the padding comprises a plurality of ridges protruding from an outer surface of the padding.
Johnson, however, teaches an analogous clamp device used for treating male urinary
incontinence (abstract; col 2 lines 24-30) wherein the device includes a cushion 12 having a
plurality of ridges protruding from an outer surface of the cushion (key ridge portion 1 attached to the inside surface of straps 5 and 6 - shown in figures 1-2; and including high portions 2 through which notches 3 are formed which notches close up when the device is wrapped around the penis - col 3 lines 3-6; key ridge portion 1 and high portions 2 are interpreted as providing a plurality of ridges that protrude from the outer surface of the cushion 12) and wherein the ridges (key ridge 1) are adapted to be in contact with a user's body during use (as shown in figure 5 - col 3 lines14-16) and are compressed to close off the flow of urine from the bladder through the urethra (col 3 lines 35-39). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the padding on the device of Bialick in view of Rennich to include a plurality of ridges protruding from an outer surface of the padding as taught by Johnson in order to provide flexibility for wrapping the device around the penis and furthermore to provide areas configured to be compressed to close off the flow of urine from the bladder through the urethra as taught by Johnson.
Claims 5-6 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bialick (US 3203421) in view of Chadwick (US 5571125).
With respect to claims 5-6, Bialick discloses the device as claimed (see rejection of claim 1) but does not explicitly disclose that the guide is formed of a rigid polymer, wherein the rigid polymer is acrylonitrile butadiene styrene.
Chadwick teaches a penile clamp device that includes a pad 13 which is analogous to the guide (element 23 of Bialick) which can be made from plastic (plastic is a rigid polymer) such as closed-cell polypropylene, styrene, abs cycolac, etc., so as to create lower manufacturing costs and facilitate cleaning (col 4 lines 29-32). Thus, 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 guide (element 23) of Bialick from a rigid polymer, wherein the rigid polymer is acrylonitrile butadiene styrene, as taught by Chadwick, in order to lower manufacturing costs and facilitate cleaning.
With respect to claims 14-15, Bialick discloses the device as claimed (see rejection of claim 9) but does not explicitly disclose that the removable guide is formed of a rigid polymer, wherein the rigid polymer is acrylonitrile butadiene styrene.
Chadwick teaches a penile clamp device that includes a pad 13 which is analogous to the guide (element 23 of Bialick) which can be made from plastic (plastic is a rigid polymer) such as closed-cell polypropylene, styrene, abs cycolac, etc., so as to create lower manufacturing costs and facilitate cleaning (col 4 lines 29-32). Thus, 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 removable guide (element 23) of Bialick from a rigid polymer, wherein the rigid polymer is acrylonitrile butadiene styrene, as taught by Chadwick, in order to lower manufacturing costs and facilitate cleaning.
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Bialick (US 3203421) in view of Krause et al (US 2002/0111640).
With respect to claim 7, Bialick discloses the device as claimed (see rejection of claim 1) but does not disclose that the curved concaved inner surface further comprises: a curved convex protrusion extending from a middle portion of the curved concave inner surface.
Krause teaches an incontinence clamp 10 (fig 2) that includes a body member 200 that has a curved concaved inner surface (surface that faces the body during use has a slightly curved, concave shape as shown in fig 2) with a raised portion or protrusion 215 configured as a curved convex protrusion as shown in figure 2 in the approximate center of the member such that when the device is clamped about the central body of the penis 250, the protrusion 215 applies increased pressure on the urethra 255, by squeezing it between the hump and the internal structures of the penis, to prevent the flow of urine (para [0030]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the guide of Bialick so that the curved concaved inner surface further comprises: a curved convex protrusion extending from a middle portion of the curved concave inner surface, like the protrusion 215 on body member 200 of Krause, in order to apply increased pressure on the urethra to prevent the flow of urine when the device is clamped about the central body of the penis.
With respect to claim 16, Bialick discloses the device as claimed (see rejection of claim 9) but does not disclose a protrusion extending from a medial position of the concave inner surface of the removable guide, the protrusion dimensioned to exert a pressure against a urethra of a user when the incontinence clamp is in a closed position.
Krause teaches an incontinence clamp 10 (fig 2) that includes a body member 200 that has a curved concaved inner surface (surface that faces the body during use has a slightly curved, concave shape as shown in fig 2) with a raised portion or protrusion 215 in the approximate center of the member such that when the device is clamped about the central body of the penis 250, the protrusion 215 applies increased pressure on the urethra 255, by squeezing it between the hump and the internal structures of the penis, to prevent the flow of urine (para [0030]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the removable guide of Bialick to include a protrusion extending from a medial position of the concave inner surface of the removable guide, the protrusion dimensioned to exert a pressure against a urethra of a user when the incontinence clamp is in a closed position, like the protrusion 215 on body member 200 of Krause, in order to apply increased pressure on the urethra to prevent the flow of urine when the device is clamped about the central body of the penis.
Double Patenting
NON-STATUTORY 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 1, 3-9 and 12-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9 of U.S. Patent No. 10624728 (the ‘728 Patent).
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 and because the application claims would have been obvious in view of the ‘728 patent to one having ordinary skill in the art.
Specifically, all the limitations of claim 1 of the present application can be found in claims 1-2 and 9 of the ‘728 patent, but the claims of the ‘728 patent differ in that the patented claims include more elements than the claims in the present application and, therefore, are more narrow and specific. Thus, the claims of the ‘728 Patent 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). Additionally, claim 1 of the ‘728 Patent does not recite that the guide is “dimensioned to span a majority of an inner surface” of the movable clamp or that the movable clamp arm is “dimensioned to partially encircle a user’s penis” as is recited in claim 1 of the present application. However, it would have been obvious to one having ordinary skill in the art to have modified the clamp of claim 1 of the ‘728 patent to have a guide and clamp arm that are dimensioned as recited in claim 1 of the present application since such modifications 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. Thus, the application claims would have been obvious in view of the ‘728 patent to one having ordinary skill in the art. For at least these reasons, claim 1 of the present application is not patentably distinct from claims 1-2 and 9 of the ‘728 patent.
All of the limitations of claim 3 can be found in claim 3 of the ‘728 Patent. All of the limitations of claim 4 can be found in claim 4 of the ‘728 Patent. All of the limitations of claim 5 can be found in claim 5 of the ‘728 Patent. All of the limitations of claim 6 can be found in claim 6 of the ‘728 Patent. All of the limitations of claim 7 can be found in claim 1 of the ‘728 Patent. All of the limitations of claim 8 can be found in claim 7 of the ‘728 Patent.
All the limitations of claim 9 of the present application can be found in claims 1-2 and 9 of the ‘728 patent, but the claims of the ‘728 patent differ in that the patented claims include more elements than the claims in the present application and, therefore, are more narrow and specific. Thus, the claims of the ‘728 Patent are in effect a “species” of the broader, “generic” invention recited in claim 9 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). Additionally, claim 1 of the ‘728 Patent does not recite that the guide “underlies a majority of a concave inner surface” of the clamp arm or that the clamp arm is “arcuate” as is recited in claim 9 of the present application. However, it would have been obvious to one having ordinary skill in the art to have modified the clamp of claim 1 of the ‘728 patent to have a guide that is dimensioned as recited in claim 9 of the present application since such modifications 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. Furthermore, it would have been obvious to form the clamp arm of claim 1 of the ‘728 patent having an arcuate shape as recited in claim 9 of the present application since such a modification would not involve anything more than choosing one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a clamp arm on an incontinence clamp. Thus, the application claims would have been obvious in view of the ‘728 patent to one having ordinary skill in the art. For at least these reasons, claim 9 of the present application is not patentably distinct from claims 1-2 and 9 of the ‘728 patent.
All of the limitations of claim 12 can be found in claim 3 of the ‘728 Patent. All of the limitations of claim 13 can be found in claim 4 of the ‘728 Patent. All of the limitations of claim 14 can be found in claim 5 of the ‘728 Patent. All of the limitations of claim 15 can be found in claim 6 of the ‘728 Patent.
All of the limitations of claim 16 can be found in claim 1 of the ‘728 Patent except that claim 1 of the ‘728 Patent does not recite that the protrusion is “dimensioned to exert a pressure against a urethra of a user when the incontinence clamp is in a closed position” as is recited in claim 16 of the present application. However, it would have been obvious to one having ordinary skill in the art to have modified the clamp of claim 1 of the ‘728 patent to have a guide that is dimensioned as recited in claim 16 of the present application since such a 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786