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 .
Application Status
Present office action is in response to application filed 06/14/2024. Claims 1-14 are currently pending in the application.
Rejections - 35 USC § 102/103
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 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.
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-3, 5-6, 8-9 and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Cohen (US 7080984 B1) cited by Applicant.
Re claims 1 and 12:
[Claim 1] Cohen discloses a circumcision training model for neonatal circumcision simulation (at least col 1, lines 45-47: use of a neonatal manikin having a generally anatomically correct simulated neonatal penis as a training tool), comprising a glans simulant configured to correspond to a neonatal glans; a shaft simulant configured to correspond to a neonatal penile shaft; a fascia-analog layer situated over the glans simulant; and a skin-analog layer situated over the fascia-analog layer, glans simulant, and shaft simulant (at least col 2, lines 38-46: An uncircumcised penis includes a shaft having a shaft skin 40, a prepuce (which folds back over itself to form an outer foreskin 41; an inner foreskin 42), a glans with a corona 43. The coronal sulcus 44 separates the glans from the shaft …); wherein the fascia-analog layer and the skin-analog layer are separate structures, wherein the skin-analog layer has a larger maximum outer diameter over the glans simulant than over the shaft simulant (at least FIG. 3 and associated text; col 3, lines 20-33: in FIG. 4, the uppermost portion of simulated prepuce 11 is then pulled up and stretched laterally over the corona and glans to form an outer layer of simulated foreskin 31 and an inner layer of simulated foreskin 32 between which is a bend in the uppermost portion, creating a preputial opening 33 neighboring the bend and formed by the contraction of the laterally stretched elastomer foreskin … the neonatal manikin is prepared for practice circumcision. The simulated disposable foreskin (SDF) 10 is deployed over the model penis 25 such that the glans is covered by two layers of foreskin 31 32, and the inner layer is adhered to the glans by "simulated adhesions" 50 formed by the rubber cement or other adhesion-simulating adhesive; FIG. 5-7 and associated text).
Alternatively, in the event Cohen is viewed as not disclosing all the claim features as claimed, for example, the “wherein the fascia-analog layer and the skin-analog layer are separate structures”, it has been held to be within the general skill of a worker in the art to make singular part as plural parts as a matter of obvious engineering choice. Nerwin v. Erlichman, 168 USPQ 177, 179 (PTO Bd. Of Int. 1969).
[Claim 12] Cohen discloses a method of making a circumcision training model for neonatal circumcision simulation (at least col 1, lines 45-47: use of a neonatal manikin having a generally anatomically correct simulated neonatal penis as a training tool), comprising forming simulants configured to correspond to a neonatal glans and a neonatal penile shaft; forming a fascia-analog layer; forming a skin-analog layer which is a separate structure from the fascia-analog layer; placing the fascia-analog layer over the simulants; and placing the skin-analog layer over the fascia-analog layer (at least col 2, lines 38-46: An uncircumcised penis includes a shaft having a shaft skin 40, a prepuce (which folds back over itself to form an outer foreskin 41; an inner foreskin 42), a glans with a corona 43. The coronal sulcus 44 separates the glans from the shaft …); wherein the fascia-analog layer and the skin-analog layer are separate structures, wherein the skin-analog layer has a larger maximum outer diameter over the glans simulant than over the shaft simulant (at least col 2, lines 56-59: The diameter "d" of the simulated skin shaft 11 is approximately equal to the diameter of neonatal penis (approximately 1 cm) but less than the diameter of the corona (approximately 1.3 cm); FIG. 3 and associated text; col 3, lines 20-33: in FIG. 4, the uppermost portion of simulated prepuce 11 is then pulled up and stretched laterally over the corona and glans to form an outer layer of simulated foreskin 31 and an inner layer of simulated foreskin 32 between which is a bend in the uppermost portion, creating a preputial opening 33 neighboring the bend and formed by the contraction of the laterally stretched elastomer foreskin … the neonatal manikin is prepared for practice circumcision. The simulated disposable foreskin (SDF) 10 is deployed over the model penis 25 such that the glans is covered by two layers of foreskin 31 32, and the inner layer is adhered to the glans by "simulated adhesions" 50 formed by the rubber cement or other adhesion-simulating adhesive; FIG. 5-7 and associated text).
Alternatively, in the event Cohen is viewed as not disclosing all the claim features as claimed, for example, the “a skin-analog layer which is a separate structure from the fascia-analog layer”, it has been held to be within the general skill of a worker in the art to make singular part as plural parts as a matter of obvious engineering choice. Nerwin v. Erlichman, 168 USPQ 177, 179 (PTO Bd. Of Int. 1969).
Re claims 2, 3, 5-6, 8, 9, 11 and 13-14:
[Claim 2] Cohen discloses wherein the fascia-analog layer and the skin-analog layer both extend over and past a corona of the glans simulant (at least col 3, lines 20-26: the uppermost portion of simulated prepuce 11 is then pulled up and stretched laterally over the corona and glans to form an outer layer of simulated foreskin 31 and an inner layer of simulated foreskin 32 between which is a bend in the uppermost portion, creating a preputial opening 33 neighboring the bend and formed by the contraction of the laterally stretched elastomer foreskin).
[Claim 3] Cohen discloses wherein the fascia-analog layer and the skin-analog layer both extend more than a quarter inch past a corona of the glans simulant down the shaft simulant (at least FIG. 4, 5 and 7 and associated text).
[Claim 5] Cohen discloses wherein the fascia-analog layer comprises a first opening, the skin-analog layer comprises a second opening, and the first and second openings are at a distal end of the circumcision training model (at least FIG. 4, 5 and 7 and associated text, for example, As shown in FIG. 4, the uppermost portion of simulated prepuce 11 is then pulled up and stretched laterally over the corona and glans to form an outer layer of simulated foreskin 31 and an inner layer of simulated foreskin 32 between which is a bend in the uppermost portion, creating a preputial opening 33 neighboring the bend and formed by the contraction of the laterally stretched elastomer foreskin). Please note that, by definition, elastomer is defined as a type of material that exhibits elastic properties, allowing it to return to its original shape after being deformed, similar to rubber bands1).
[Claim 6] Cohen discloses wherein the fascia-analog layer and the skin-analog layer are made of latex rubber (col 3, lines 20-26 and 46-50: the SDF may, for example but not limitation, be fabricated with latex or synthetic elastomers: in FIG. 4, the uppermost portion of simulated prepuce 11 is then pulled up and stretched laterally over the corona and glans to form an outer layer of simulated foreskin 31 and an inner layer of simulated foreskin 32 between which is a bend in the uppermost portion, creating a preputial opening 33 neighboring the bend and formed by the contraction of the laterally stretched elastomer foreskin … the SDF may, for example but not limitation, be fabricated with latex or synthetic elastomers; claims 1, 2 and 10).
[Claim 8] Cohen discloses wherein the skin-analog layer is temporarily separable from the fascia-analog layer by application of a first external force and restores contact with the fascia-analog layer if the first external force is removed, and the fascia-analog layer is elastically deformable such that the fascia-analog layer is temporarily separable from the glans simulant by application of a second external force and restores contact with the glans simulant if the second external force is removed (at least FIG. 4, 5 and 7 and associated text, for example, As shown in FIG. 4, the uppermost portion of simulated prepuce 11 is then pulled up and stretched laterally over the corona and glans to form an outer layer of simulated foreskin 31 and an inner layer of simulated foreskin 32 between which is a bend in the uppermost portion, creating a preputial opening 33 neighboring the bend and formed by the contraction of the laterally stretched elastomer foreskin). Please note that, by definition, elastomer is defined as a type of material that exhibits elastic properties, allowing it to return to its original shape after being deformed, similar to rubber bands2).
[Claim 9] Cohen discloses wherein the glans simulant and shaft simulant are of a unitary construction (col 1, line 67 – col 2, line 1: model penis, itself, may be supplied as a single unit with the foreskin, for single disposable usage).
[Claim 11] Cohen discloses the circumcision training model of claim 1, configured attached or attachable to an anatomical doll (at least FIG. 1 is a perspective view of a male neonate manikin).
[Claim 13] Cohen discloses wherein the steps of forming the fascia-analog layer and the skin-analog layer are non-casting processes (at least col 3, lines 46-54: The SDF may be manufactured generally from the types of materials and processes used in condom manufacture. Thus the SDF may, for example but not limitation, be fabricated with latex or synthetic elastomers, including polyurethane and neoprene. The SDF shape may be established by forming a mandrel in the shape of an elongated neonatal penis shaft. The mandrel will then be dipped into a solution of elastomer, once or twice to generate the shaft skin 11 having the required thickness). Please note that, as per Applicant’s disclosure, “non-casting processes” are “not limited to by painting or dipping”.
[Claim 14] Cohen discloses wherein the steps of forming the fascia-analog layer and the skin-analog layer are by painting or dipping (at least col 3, lines 46-54: The SDF may be manufactured generally from the types of materials and processes used in condom manufacture. Thus the SDF may, for example but not limitation, be fabricated with latex or synthetic elastomers, including polyurethane and neoprene. The SDF shape may be established by forming a mandrel in the shape of an elongated neonatal penis shaft. The mandrel will then be dipped into a solution of elastomer, once or twice to generate the shaft skin 11 having the required thickness).
Claims 4, 7 and 10 are rejected under 35 U.S.C. 103 as obvious over Cohen.
Re claims 4, 7 and 10:
[Claim 4] Cohen appears to be silent on wherein each of the fascia-analog layer and the skin-analog layer is 0.010-0.020 inches in thickness. However, Cohen further discloses “the shaft skin 11 having the required thickness” (col 3, lines 53-54). Hence, it would have been obvious to one of ordinary skill to modify Cohen as claimed, since it has been held that the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
[Claim 7] Cohen appears to be silent on wherein the glans simulant and shaft simulant are made of silicone rubber. However, as shown above, Cohen discloses a simulated disposable foreskin (SDF) fabricated, for example but not limitation, with latex or synthetic elastomers, including polyurethane and neoprene (col 3, lines 20-26 and 46-50; claims 1, 2 and 10). Hence, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the invention to have modified Cohen as claimed because this would amount to no more than applying known techniques to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
[Claim 10] Cohen appears to be silent on wherein the fascia-analog layer and the skin-analog layer are different thicknesses from one another. However, Cohen discloses generating shaft skin having the required thickness (col 3, lines 52-54). Hence, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the invention to have modified Cohen as claimed because this would amount to no more than applying known techniques to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
Conclusion
The prior art made of record and not relied upon is listed in the attached PTO Form 892 and is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDDY SAINT-VIL whose telephone number is (571)272-9845. The examiner can normally be reached Mon-Fri 6:30 AM -6:00 PM.
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/EDDY SAINT-VIL/Primary Examiner, Art Unit 3715
1 https://www.sciencedirect.com/topics/earth-and-planetary-sciences/elastomer
2 https://www.sciencedirect.com/topics/earth-and-planetary-sciences/elastomer