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 26 is objected to because of the following informalities: the limitations, “…The urethra condom of claim 21,wherein the body comprises a material chosen from the group consisting of latex, polyurethane, polyisoprene, polyvinyl alcohol, a solvent soluble polymer material and lamb intestine” should read, The urethra condom of claim 21,wherein the body comprises a material selected from the group consisting of latex, polyurethane, polyisoprene, polyvinyl alcohol, a solvent soluble polymer material and lamb intestine”. Appropriate correction is required.
Claim 42 is objected to because of the following informalities: the limitations, “…The method of claim 38, wherein the dissolvable material is chosen from the group consisting of polyvinyl alcohol and a solvent soluble polymer material” should read, “…The method of claim 38, wherein the dissolvable material is selected from the group consisting of polyvinyl alcohol and a solvent soluble polymer material”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 39-40 and 42 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 39 recites the limitation "the dissolvable agent" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 40 recites the limitation "the dissolvable agent" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 42 recites the limitation "the dissolvable agent" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
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) 21, 23-26 and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hardy U.S. Patent No. (6,145,507).
With respect to claim 21, Hardy discloses a urethra condom (abstract and 2, figs.1-8, figs.5-8 are the same embodiment as figs.1-4 and in addition to having an applicator); Note: (the condom is being utilized at the head or tip of the penis where the urethra is located at 11, see fig.4) and ([Col.2], lines 64-67) and ([Col.3], lines 1-2) comprising:
a body (where element 10 is located in fig.1) extending between a rim (at the ring of the condom located in figs. 3-4) at a proximal end or the top at the circumferential end and a reservoir tip (12) and ([Col.3], lines 8-13) at a distal end (as shown in figs.3-4), the body having an outer convex surface ([Col.4], lines 10-12) and ([Col.4], line 57) extending between the rim (where the ring is located or the top of the condom) and the reservoir tip (12) and an inner concave surface ([Col.4], lines 57-58) configured to contact at least a portion of a head of a human penis when the condom is applied thereto (as shown in figs.3-4), the body having a height between the proximal end and the distal end such that when the condom is disposed on the penis the rim at the proximal end of the body is disposed above a bottom edge of a head of the penis (as shown in figs.3-4),
wherein at least a portion of the inner concave surface has an adhesive (14) and ([Col.3], lines 14-18) disposed thereon configured to removably adhere the body to the head of the penis when the condom is disposed on the penis (as shown in figs.3-4 and 7-8).
With respect to claim 23, Hardy discloses the reservoir tip (12) has a generally cylindrical body (as shown in figs.3-4), the reservoir tip (12) configured to receive and collect bodily fluids from the penis following sexual intercourse; Note: the tip allows for collecting ejaculate during sexual intercourse.
With respect to claim 24, Hardy discloses the inner concave surface defines a circumferential gap between the reservoir tip and the at least a portion of the inner concave surface with an adhesive, the adhesive not being disposed on the circumferential gap (adhesive free center 13 of the inner surface of the condom 2, figs. 1-4) and ([Col.3], lines 17-18, base 4 is of substantially semi-spherical shape and is coated on its inner surface with a pressure sensitive adhesive 14, leaving the central area 13 free of adhesive) and ([Col.4], lines 4-5).
With respect to claim 25, Hardy discloses the inner concave surface defines a rim section at the proximal end of the body, the adhesive not disposed on the rim section (see adhesive 14 not on an outer circumferential area of the rim, as shown in figs.7-8).
With respect to claim 26, Hardy discloses the body comprises a material chosen from the group consisting of latex ([Col.2], lines 64-67).
With respect to claim 28, Hardy discloses a removable sheeting or protective strip (23) that covers the adhesive (14), the sheeting being removable to expose the adhesive prior to use of the urethra condom ([Col.4], lines 34-39).
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.
Claim(s) 22 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Hardy as applied to claim 21 above, and further in view of Sun (CN 108938176 A) and evidenced by Tam et al. U.S. (2004/0107969 A1).
With respect to claim 22, Hardy substantially discloses the invention as claimed except body is made of a dissolvable material.
Sun however, teaches a soluble condom form from polyvinyl alcohol (abstract); wherein the polyvinyl alcohol is dissolvable when in contact with female secretion [Page 3], 3rd paragraph]. Polyvinyl alcohol is known to dissolve in the presence of vaginal moisture as evidenced by Tam et al. in para [0052]. Note: (1) during sexual intercourse arousal and at climax/orgasm the body temperature increases above the normal body temperature (typically
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37∘C or 98.6 ∘F) and since the vaginal ejaculate/secretions contains water, the heat generated during sexual intercourse arousal and at climax/orgasm as a result of the physiological response resulting from increased metabolic activity and blood flow would result in the dissolving of the dissolvable material, in this instance, polyvinyl alcohol; and (2), furthermore, Applicant discloses in the original filed specification the use of polyvinyl alcohol for manufacturing the condom, see para [0069, “… In some embodiments, the condom 10 is manufactured or constructed from a material capable of dissolving (e.g., a dissolvable material, polyvinyl alcohol, solvent soluble polymer, etc. in such embodiments, the condom 10 may be capable of dissolving such that removing the condom 10 from the penis 90 may include dissolving the condom 10 (e.g., following use in sexual intercourse”).
In view of the teachings of Sun, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to form the condom of Hardy of a dissolvable material in order to safely and comfortably remove the condom from the penis of the user.
With respect to claim 43, the combination of Hardy/Sun substantially discloses the invention as claimed. Sun further teaches the dissolvable material or polyvinyl alcohol (see abstract) dissolves when exposed to a water above a predetermined temperature. Polyvinyl alcohol is known to dissolve in the presence of vaginal moisture as evidenced by Tam et al. in para [0052]; during sexual intercourse arousal and at climax/orgasm the body temperature increases above the normal body temperature (typically
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37∘C or 98.6 ∘F) and since the vaginal ejaculate/secretions contains water, the heat generated during sexual intercourse arousal and at climax/orgasm as a result of the physiological response resulting from increased metabolic activity and blood flow would result in the dissolving of the dissolvable material, in this instance, polyvinyl alcohol.
Claim(s) 27 is rejected under 35 U.S.C. 103 as being unpatentable over Hardy as applied to claim 21 above, and further in view of Winkler U.S. Patent No. (6,148,819).
With respect to claim 27, Hardy substantially discloses the invention as claimed except adhesive properties of the adhesive are configured to be deactivated when the adhesive comes in contact with an adhesive remover substance.
Winkler however, teaches a method and a kit for adhering a glans cap, or micro-condom, to the glans of the penis. The kit contains a liquid adhesive and an applicator, a liquid solvent and an applicator, and a glans cap having a minimum of a reservoir, a pre-applied adhesive coating on the proximal surface of the annular flange, and a through-passage from the proximal surface of the annular flange into the reservoir (abstract) and a pre-applied adhesive (4, such as a medical double-sided transfer tape [Col.3], lines 6-11] and (figs.1-5); wherein the method comprises pre-applying a fast-curing liquid adhesive to the surface of the glans before applying a high tack tape adhesive to the glans for the purpose of securing a glans cap to the glans. The coating cured over the surface of the glans serves as a stable bonding surface for adhesion of a glans cap. A hypo-allergenic solvent is used post coitus to dissolve the coating thereby removing the glans cap from the glans penis ([Col.1], lines 16-22); wherein the post coitus, the glans cap can be separated from the glans by dissolving the cured liquid adhesive with a medically-approved alcohol based solvent such as isopropyl alcohol, denatured alcohol, medically-approved petroleum distillates such as the product Detachol by Ferndale Laboratories, or soapy water or a combination thereof ([Col.2], lines 24-31] and ([Col.3], lines 24-31).
In view of the teachings of Winkler, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the condom of Hardy by incorporating a solvent for deactivating the adhesive post coitus to dissolve the adhesive thereby removing the condom from the glans penis.
Claim(s) 37-38 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Hardy U.S. Patent No. (6,145,507) in view of Sun (CN 108938176 A) and evidenced by Tam et al. U.S. 2004/0107969 A1).
With respect to claim 37, Hardy substantially and inherently discloses a method for removing a urethra condom (2, figs.1-8) from a human penis, Note: since Hardy discloses the condom being utilized on the glans penis of the user (as shown in figs.3-4); regarding the method step claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed, it will inherently perform the method steps as claimed. Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986);
the urethra condom (the condom is being utilized at the head or tip of the penis where the urethra is located at 11, see fig.4, as such, is a urethra condom) and ([Col.2], lines 64-67) and ([Col.3], lines 1-2) having a body (where element 10 is located in fig.1) extending between a rim (at the ring of the condom located in figs. 3-4) at a proximal end or the top and a reservoir tip (12) and ([Col.3], lines 8-13) at a distal end (as shown in figs.3-4), the body having an outer convex surface ([Col.4], lines 10-12) and ([Col.4], line 57) extending between the rim (where the ring is located or the top of the condom) and the reservoir tip (12) and an inner concave surface ([Col.4], lines 57-58) configured to contact at least a portion of a head of a human penis when the condom is applied thereto (as shown in figs.3-4), the body having a height between the proximal end and the distal end such that when the condom is disposed on the penis the rim at the proximal end of the body is disposed above a bottom edge of a head of the penis (as shown in figs.3-4), at least a portion of the inner concave surface has an adhesive (14) and ([Col.3], lines 14-18) disposed thereon configured to removably adhere the body to the head of the penis when the condom is disposed on the penis (as shown in figs.3-4).
Hardy substantially discloses the invention as claimed except the method comprising: applying an agent or water above a predetermined temperature to the body, and removing the body from on top of the head of the penis.
Sun however, teaches a soluble condom form from polyvinyl alcohol (abstract); wherein the polyvinyl alcohol is dissolvable when in contact with female secretion [Page 3], 3rd paragraph]. Polyvinyl alcohol is known to dissolve in the presence of vaginal moisture as evidenced by Tam et al. in para [0052]. Note: Applicant’s discloses in the instant invention, in the original filed specification the use of polyvinyl alcohol for manufacturing the condom, see para [0069, “… In some embodiments, the condom 10 is manufactured or constructed from a material capable of dissolving (e.g., a dissolvable material, polyvinyl alcohol, solvent soluble polymer, etc.], as such applying an agent would remove the body of the condom (a female ejaculate/secretion is considered a biological/physiological agent as it contains biochemical compounds.
In view of the teachings of Sun, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Hardy by applying an agent and removing the body from on top of the head of the penis in order to safely and comfortably remove the condom from the head of the penis.
With respect to claim 38, the combination of Hardy/Sun substantially discloses the invention as claimed. Sun further teaches the body is made of a dissolvable material [Abstract, polyvinyl alcohol] and evidenced by Tam et al.; Polyvinyl alcohol is known to dissolve in the presence of vaginal moisture as evidenced by Tam et al. in para [0052].
With respect to claim 42, the combination of Hardy/Sun substantially discloses the invention as claimed. Sun further discloses the dissolvable material is chosen from the group consisting of polyvinyl alcohol [Abstract].
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 21 and 27 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. (11,331, 212 B1). Although the conflicting claims 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.
Claim 21 of the instant application recites a urethra condom comprising: a body extending between a rim at a proximal end and a reservoir tip at a distal end, the body having an outer convex surface extending between the rim and the reservoir tip and an inner concave surface configured to contact at least a portion of a head of a human penis when the condom is applied thereto, the body having a height between the proximal end and the distal end such that when the condom is disposed on the penis the rim at the proximal end of the body is disposed above a bottom edge of a head of the penis, wherein at least a portion of the inner concave surface has an adhesive disposed thereon configured to removably adhere the body to the head of the penis when the condom is disposed on the penis.
Claim 1 of U.S. Patent No. (11,331,212 B1) recites a urethra condom kit comprising: one or more urethra condoms, each of the one or more urethra condoms comprising a body extending between a rim at a proximal end and a reservoir tip at a distal end, the body having an outer convex surface extending between the rim and the reservoir tip and an inner concave surface configured to contact at least a portion of a head of a human penis when the condom is applied thereto, the body having a height between the proximal end and the distal end such that when the condom is disposed on the penis the rim at the proximal end of the body is disposed above the bottom edge of a head of the penis, at least a portion of the inner concave surface having an adhesive disposed thereon configured to removably adhere the body to the head of the penis when the condom is disposed on the penis; an adhesive remover configured for application by the user to the concave inner surface of the body such that the adhesive remover contacts the adhesive on the concave inner surface to thereby deactivate the adhesive to allow the removal of the body from the head of the penis; and a package removably housing the one or more urethra condoms and the adhesive remover, wherein the package comprises a plurality of individual disposable condom packages, each of the disposable condom packages comprising a base having a bottom layer and a dome portion, the body disposed on the dome portion such that the concave inner surface of the body is disposed on the dome portion, a cover removably attached to the base to seal the body therebetween, the bottom layer and dome portion defining a cavity therebetween configured to releasably house the adhesive remover therein, the cavity being sealed with a removable seal.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 21 of the current application and claim 1 of patent (‘212) lies in the fact that the patented claims includes many more elements and is thus much more specific. Thus the invention of claim 1 of patent (‘212) is in effect a “species” of the “generic” invention of current application claim 21. It has been held that the generic invention is “anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 21 of the current application is anticipated by claim 1 of patent ('212), it is not patentably distinct from claim 1 of patent ('212).
All of the limitations of claim 27 can be found in claim 5 of U.S. Patent No. (11,331,212 B1).
Allowable Subject Matter
Claims 39-40 are would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 41 and 44 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.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
The prior art(s) of record fails to show or make obvious the claimed combinations of elements particularly the limitations as set forth in dependent claims 39-41 and 44 which recite features not taught or suggested by the prior art of record, in combination with the other elements (or steps) of the apparatus and method recited in the claims.
Conclusion
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/OPHELIA A HAWTHORNE/ Primary Examiner, Art Unit 3786