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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). Certified copies of the following parent applications, filed in Japan, have been received.
2023-013553, filed 31 January 2023
2023-075234, filed 28 April 2023
Claim Objections
The claims contain minor informalities.
In claim 1, the language “… wherein the receptacle portion has [[such]] a flat shape [[as to have]] and a bulge part in a lateral direction, and the check valve portion forms a valve opening having a slit shape [[such that substantially a]] in the lateral direction [[is a longitudinal direction]].” should be changed for clarity.
In claim 3, the language “… wherein: a minimum thickness dimension of the guide portion is [[configured to be]] smaller than a minimum thickness dimension of the introduction portion.” should be changed for clarity.
In claim 5, the language “… and a minimum thickness dimension of the receptacle portion is [[configured to be]] smaller than any of a minimum thickness dimension of the guide portion and …” should be changed for clarity.
In claim 6, the language “… and toward the receptacle portion at respective positions close to each other [[in a manner separate from each other]] and with a gap separating the valve membrane parts.” should be revised for clarity.
In claim 7, the language “… wherein the guide portion [[is configured to have]] has a length [[dimension]] larger than half an inner diameter [[dimension]] of …” should be changed for clarity.
Claim 8 calls for “… wherein: being configured by integrally forming from a flexible material: a front covering portion including a semi-cylindrical front outer surface part and a semi-cylindrical front inner surface part, the front covering portion having a semi-cylindrical shape having a fixed thickness; and a back covering portion including a flat back outer surface part and a back inner surface part having a substantially V-shaped cross-sectional shape, the back covering portion having such a shape that a thickness thereof decreases toward a center.” This language appears to describe more of the detachment prevention member’s features and should be revised for clarity. Examiner suggests to reformat this claim in terms of “… wherein the detachment prevention member comprises …” followed by its features. Note the format of the claims in the references cited in this office action.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson ‘729; David W. et al. (US 20090036729 A1) in view of Fader; Miranda et al. (WO 2019063994 A1).
Regarding claim 8, Anderson ‘729 discloses a detachment prevention member having a tubular shape (¶ [0002], [0010], [0051] One exemplary embodiment of a penile compression device 10 is provided in FIGS. 1A-2);
the detachment prevention member being configured to be used together with a biological fluid receptacle container (¶ [0067], As shown in FIGS. 4A-D, the absorbent attachment 20 is designed to contain the penis 3 in an opening 22 thereof);
including: a container body comprising at least a hollow receptacle portion configured to receive a biological fluid and a hollow introduction portion configured to communicate with one side of the receptacle portion and introduce the biological fluid (¶ [0073] The absorbent sleeve 20, 20a may be manufactured from polyurethane open celled foams or polyolefin open celled foams such as Willsorb.RTM. manufactured by Ilibruck, Inc. A water resistant barrier layer may be disposed and adherent to the outer surface of the foam that will prevent inadvertent leakage of any absorbed urine); and
a closure member, wherein: being configured by integrally forming from a flexible material (¶ [0059] The penile compression device 10 may be generally ovoid in shape; ¶ [0060] The penile compression device 10 may be manufactured from semi-rigid thermoplastic materials. Such materials may include, but are not limited to Delrin.RTM. (Dupont, Inc.) or a polycarbonate (Entec, Inc.) using standard thermoplastic extrusion or injection molding practices);
a front covering portion including a semi-cylindrical front outer surface part and a semi-cylindrical front inner surface part (¶ [0052] The penile compression device 10 includes a closed planar structure 14 defining oppositely disposed first and second support arms. The first and second arms define inner and outer side surfaces. As shown in FIGS. 1A-2, the first and second support arms resemble a top support arm proximate the dorsal penile neurovascular bundle 9 and a bottom support arm proximate urethra 5; ¶ [0053] As shown in FIG. 2, the inner side surfaces of the support arms of the planar structure 14 bias toward each other in a resting position);
the front covering portion having a semi-cylindrical shape having a fixed thickness (Figs. 2, 4B-4C, the top support arm has a semi-cylindrical shape and a fixed thickness); and
a back covering portion including a flat back outer surface part and a back inner surface part having a substantially V-shaped cross-sectional shape (¶ [0052] The penile compression device 10 includes a closed planar structure 14 … the first and second support arms resemble a top support arm proximate the dorsal penile neurovascular bundle 9 and a bottom support arm proximate urethra 5; ¶ [0056] An occlusive protrusion 12 may be disposed proximate the urethra 5 on one of the first or second support arms. Preferably, the occlusive protrusion 12 is disposed on the bottom support arm proximate the urethra 5).
Anderson ‘729 does not explicitly disclose that the back covering portion has a thickness that decreases toward its center. Fader discloses a penile compression device for managing urinary incontinence (p. 1, lines 1-10; p. 8, lines 15-25, penile compression device 100);
including a back covering portion having such a shape that a thickness thereof decreases toward a center (p. 15, lines 30-35, As shown in Fig. 1 , the first spring part 106 may include a recess 109 in its inner surface 182. The recess 109 may be located towards the centre along the length of the first spring part 106 and is configured to receive the urethral bulge of the penis).
Fader adjusts the shape of a detachment prevention member and also provides an alternative way to compress the wearer’s urethra (p. 16, lines 20-25, The recess 109 in the first spring part 106 may be located between the first 1 1 1 and the second 1 13 raised portions, which allows the raised 1 1 1 , 1 13 and recessed 109 portions to cooperate with each other to locate and compress the urethra). One would be motivated to modify Anderson ‘729 with Fader’s tapered back covering portion since Anderson ‘729 discloses at least seven other embodiments of the detachment prevention member which vary its shape and construction (¶ [0074], FIGS. 8A-9 illustrate another preferred embodiment for a penile compression device 40; ¶ [0083], FIGS. 10A and B show a penile clamp 60 that may be formed as a one-piece integral structure; ¶ [0086] FIGS. 11A-B show another clamp 80; ¶ [0088], FIGS. 12A-B show another clamp 100; ¶ [0090], FIGS. 13A-B show another clamp 120; ¶ [0092] FIGS. 14A-B show another embodiment of a clamp 140; ¶ [0094] FIGS. 15A-B show another embodiment of a clamp 160). Therefore, it would have been obvious to modify Anderson ‘729 with Fader’s tapered back covering portion in order to experiment with further shapes and designs of the detachment prevention member.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 4 and 6 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 of Imai; Shigeo et al. (US 12011385 B2) in view of Sharma; Amit Kumar et al. (US 20230020563 A1).
Regarding pending claim 1, Imai claims a container body configured by integrally forming from a material having a low hardness and a high elongation (claim 1, A collecting implement comprising: a cylindrical body portion having a softness and a stretchability; claim 4, wherein a fitting portion … is formed integrally with the body portion on the inlet portion side);
a hollow receptacle portion configured to receive a biological fluid (claim 1, a hollow portion formed in the body portion);
a hollow introduction portion configured to communicate with one side of the receptacle portion and including an introduction port part for introducing the biological fluid (claim 1, wherein the hollow portion comprises: an inlet portion which is formed such that one end side of the body portion is open and through which a material is introduced);
a hollow outlet portion configured to communicate with an other side of the receptacle portion and including an outlet port part for discharging the biological fluid (claim 3, wherein the hollow portion comprises: an outlet portion … so as to discharge the material through the outlet portion); and
a check valve portion formed at the guide portion and configured to prevent backflow of the biological fluid (claim 2, wherein a check valve for preventing the material contained in the collecting portion from flowing back to the inlet portion side is disposed between the collecting portion and the inlet portion);
wherein: the receptacle portion has a bulge part in a lateral direction (claim 1, a predetermined part is more stretchable than a part of the collecting portion other than the predetermined part so that the predetermined part can bulge toward an outer side of the body portion); and
the check valve portion forms a valve opening (claim 2, wherein a check valve for preventing the material contained in the collecting portion from flowing back to the inlet portion side is disposed between the collecting portion and the inlet portion).
Regarding the hollow guide portion, Imai claims an implement comprising a hollow receptacle portion, a hollow introduction portion, a hollow outlet portion and a check valve portion as discussed above. Imai further claims that the implement is configured to conduct fluid or material (claim 3, a discharge mechanism … so as to discharge the material through the outlet portion). This implies that the implement forms a continuous fluid path. Therefore, any region or portion between Imai’s receptacle and introduction portions constitutes a hollow guide portion.
Regarding the check valve portion’s valve opening, Imai claims that the check valve prevents material from flowing back (claim 1). This implies that the check valve has at least one opening which permits fluid to pass in one direction.
Imai does not explicitly claim that the receptacle portion has a flat shape or that the valve opening has a slit shape. Sharma discloses a urine removal device (¶ [0003], [0004], [0013], [0014], [0068], [0077] Referring to FIG. 1A-1F, a urine removal device 1);
comprising a receptacle portion having a flat shape (¶ [0077], In a first embodiment illustrated in FIG. 1A, urine removal device 1 comprises a pouch 2; ¶ [0079], each fluid compartment 102, 104 may be formed of a single continuous side wall having two opposite surfaces, where one of the two opposite surfaces forms an external sidewall and the other of the two opposite surfaces forms an internal sidewall); and
a check valve portion comprising a slit-shaped valve opening (¶ [0080] The pouch 2 additionally comprises a fluid transmission passageway 4 … the fluid transmission passageway 4 comprises a thin-film unidirectional fluid flow valve or a flutter valve configured to enable fluid flow from the first fluid compartment 102 to the second fluid compartment 104, and to prevent fluid flow from the second fluid compartment 104 to the first fluid compartment 102).
Sharma describes how to construct a container body from commercially available polymers and elastomers (¶ [0069], [0081], The flexible sheets may comprise one or more fluid-tight (liquid-impermeable) materials (for example, polyvinyl chloride … ethylene-vinyl acetate, polyvinylidene dichloride … ethylene vinyl alcohol, natural rubber latex, silicon rubber, polyurethane … etc.)). One would be motivated to modify Imai’s claims with Sharma’s flat receptacle portion and slit-shaped valve opening since Imai claims a soft and stretchable material a (claim 1, a cylindrical body portion having a softness and a stretchability). Therefore, it would have been obvious to modify Imai’s claims with Sharma’s flat receptacle portion and slit-shaped valve opening in order to construct Imai’s implement with easily obtained materials.
Regarding pending claim 4, Imai claims a container body wherein the receptacle portion includes a high elongation region having an elongation higher than an elongation of any region of the introduction portion and the outlet portion (claim 1, wherein the predetermined part is thinner than the part of the collecting portion other than the predetermined portion so as to be more stretchable than the part of the collecting portion other than the predetermined part).
Regarding pending claim 6, Imai does not explicitly claim that the check valve portion includes a pair of valve membrane parts. Sharma discloses a check valve portion including a pair of valve membrane parts arranged facing each other and toward the receptacle portion at respective positions close to each other in a manner separate from each other (¶ [0080], the fluid transmission passageway 4 comprises a thin-film unidirectional fluid flow valve or a flutter valve … a fluid inlet 42, a fluid outlet 44 and a lumen 46 that is formed from one or more collapsible flexible sheets; ¶ [0103], With reference to the cut-open illustration in FIG. 4A, an embodiment of a pouch 52 is shown comprising a first fluid compartment formed from walls 55 and 56, and each having inner surfaces 55b and 56b respectively … the inner surfaces of one or both of walls 55 and 56 may have flow directors which may, for example, be molded, hot-rolled, deposited, bonded, spray-coated, etched, formed or embossed on the inner surface or attached as a laminate on the inner surface).
Sharma explains how to construct a check valve from easily obtained materials, and which can also fold inside a receptacle portion. One would be motivated to modify Imai’s claims with Sharma’s membrane parts to construct a check valve from commercially available polymers and materials.
Claim 2 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 of Imai; Shigeo et al. (US 12011385 B2) in view of Anderson; Verne M. (US 6068618 A).
Regarding claim 2, Imai claims a container body as discussed above (claims 1-4). Imai does not explicitly claim that the support part includes large and small diameter regions and a receiving space. Anderson discloses an external male catheter (col. 2, lines 10-20; col. 5, lines 1-10, catheter 20);
comprising a receptacle portion (col. 5, lines 10-15, first tubular portion 24 that is of a greater diameter than the drain tube connection portion 22); and
an introduction portion (col. 5, lines 45-50, The cuff 38 of the illustrated embodiment ends in a roll 42 like a condom. Alternately, the cuff 42 may be completely unrolled);
wherein: a support part of a guide portion includes a large diameter region and a small diameter region formed at a position closer to the introduction portion than the large diameter region, and a receiving space bottom part of the receptacle portion is arranged at a position corresponding to the small diameter region (col. 5, lines 35-40, The reduced diameter portion 30 is connected to a cuff 38 by a third transition section 40. The cuff 38 is larger in diameter than the reduced diameter portion 30).
Anderson more securely anchors the container around a wearer’s penis (col. 5, lines 55-60, The reduced diameter portion 30 snugly engages the shaft of the penis 44 while the first tubular portion 24 encloses the glans of the penis 44). One would be motivated to modify Imai’s claims with Anderson’s large and small diameter regions and receiving space so that the container body can fit more reliably on a wearer’s penis. Therefore, it would have been obvious to modify Imai’s claims with Anderson’s large and small diameter regions and receiving space in order to retain the container body more securely.
Allowable Subject Matter
Claim 3 is allowable.
Claims 5, 7 and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter.
Imai; Shigeo et al. (US 12011385 B2) does not claim guide portion, wherein a minimum thickness dimension of the guide portion is smaller than a minimum thickness dimension of the introduction portion; or that the guide portion has a length larger than half an inner diameter of an introduction channel. At most, Imai claims a collecting implement and implies that it includes a guide portion, without claiming further details of the guide portion or its dimensions.
Imai also does not claim that a minimum thickness dimension of the receptacle portion is smaller than any of a minimum thickness dimension of the guide portion and a minimum thickness dimension of the introduction portion. At most, Imai claims an outlet portion which is thicker than a collecting portion (claim 3, an outlet portion which is formed to be thick in relation to the collecting portion).
Anderson ‘729; David W. et al. (US 20090036729 A1) and Fader; Miranda et al. (WO 2019063994 A1) do not teach or suggest a front covering portion having a foreskin accommodation window. Instead, Anderson ‘729 shows a front covering portion consisting of a monolithic band (Figs. 1A-4D; closed planar structure 14) or various embodiments comprising interlocking or assembled bands (Figs. 6A-15B). One of Anderson ‘729’s embodiments includes an adhesive patch, but does not include a foreskin accommodation window (¶ [0068] In this instance, the sleeve 20 may be attached to the outer surface of the penile compression device 10 through use of an adhesive surface or strip or use of a Velcro.RTM. closure (FIGS. 4A-B)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhang, Jun-Jian CN 102266256 A
Li, Yong-Tong CN 102871787 A
Ren, Li et al. CN 214805871 U
Yoshihiko; Hirao JP 6769939 B2
Moss; David H. US 3559651 A
Stein; David US 4022213 A
Schneider; Barry L. et al. US 4759753 A
Abe; Tomematsu US 5308163 A
Goulter; Victor H. US 5618277 A
Kubalak; Thomas P. et al. US 6039750 A
Bakane, Ramesh US 20040173219 A1
Timm, Gerald W. et al. US 20050256365 A1
Smith; Larry David US 20080250554 A1
Anderson; David W. et al. US 20090036729 A1
Velez Wiesner; Juan Felipe US 20180055617 A1
Acosta; Fred US 20190314189 A1
Nishiyama; Tetsuryuu US 20190321153 A1
Glisan; Duane L. et al. US 20200297470 A1
Nishiyama; Tetsuryuu US 20200397553 A1
Kim; Myung Sook US 20210290355 A1
Duval; Landon US 20210361463 A1
Jung; Min Ho US 20220346925 A1
Sharma; Amit Kumar et al. US 20230020563 A1
Buddharaju; Venkata US 20230079669 A1
Joh; William Kyungha US 20230270584 A1
Garric; Xavier et al. US 20250114233 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
Prosecution Insights