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 .
Response to Amendment
The Amendment filed 11/19/2025 has been entered. Claims 196-216 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 7/8/2025.
The specification was received on 11/19/2025.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because abstract contains more than 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 196, 207, 209 and 211 are objected to because of the following informalities:
Regarding claim 196, lines 7-12, applicant is requested to amend the claim to clarify that “a first substance” is same as “an infusion liquid” and “a second substance” is same as “a drug” to avoid any confusion regarding whether “a first substance” and “a second substance” are same or different from “an infusion liquid” and “a drug” respectively.
Regarding claim 207, lines 5-10, applicant is requested to amend the claim to clarify that “a first substance” is same as “an infusion liquid” and “a second substance” is same as “a drug” to avoid any confusion regarding whether “a first substance” and “a second substance” are same or different from “an infusion liquid” and “a drug” respectively.
Regarding claim 209, the recitation of “infusion liquid” appears to be amended to recite “the infusion liquid” in order to refer to “an infusion liquid” recited in claim 207.
Regarding claim 211, the recitation “infusion liquid” appears to be amended to recite “the infusion liquid” in order to refer to “an infusion liquid” recited in claim 207.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a mechanism for individually opening a connection between the second compartments and theat least one first compartment” in claim 200.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 196, 197, 199-203, 207-213, 215 and 216 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thierfelder et al. (US 2004/0034338 A1) in view of Forsell (US 2007/0233019 A1).
Regarding claim 196, Thierfelder discloses a penis erection stimulation system 10 (figure 1), comprising a fully implantable drug delivery device (figure 1) for delivering a drug in relation to a penis to achieve erection of the penis (paragraph 0028) and at least one reservoir 36 (and compartment holding fluid stored underside of the element 12, paragraph 0039) adapted for implantation inside the patient's body to store the drug to be delivered,
wherein the reservoir comprises at least one first compartment (paragraph 0039, compartment holding fluid stored underside of element 12) accommodating or adapted to accommodate a first substance (paragraph 0039) and at least one second compartment 36 accommodating or adapted to accommodate a second substance (paragraph 0038, lines 1-2),
wherein the at least one first compartment accommodates or is adapted to accommodate an infusion liquid (paragraph 0039) and the at least one second compartment accommodates or is adapted to accommodate a drug (paragraph 0038, lines 1-2) for mixing with the infusion liquid of the first compartment, wherein the drug contained in the at least one second compartment is a drug for stimulating penis erection (paragraph 0028, lines 10-13),
wherein the system further comprises a mixing chamber 34 for mixing the infusion liquid from the at least one first compartment with the drug from one or more of the at least one second compartment (paragraph 0039, paragraph 0040, lines 1-6, paragraph 0041, lines 1-3), and
wherein the mixing chamber 34 is separately arranged (figure 2) for mixing the infusion liquid from the at least one first compartment with the drug from one or more of the at least one second compartment.
Thierfelder is silent regarding wherein the fully implantable drug delivery device comprises an implantable infusion needle arranged to inject the drug into a tissue.
However, Forsell teaches a design of an implantable drug delivery device wherein the fully implantable drug delivery device (figure 1) comprises an implantable infusion needle 1 arranged to inject the drug into a tissue for the purpose of penetrating through any fibrosis when the device is implanted in the patient’s body (paragraph 0008, lines 1-5) thereby implementing the use of the implantable pump for the long-term basis (paragraph 0005).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the fully implantable drug delivery device of Thierfelder to incorporate wherein the fully implantable drug delivery device comprises an implantable infusion needle arranged to inject the drug into a tissue as taught by Forsell for the purpose of penetrating through any fibrosis when the device is implanted in the patient’s body (paragraph 0008, lines 1-5) thereby implementing the use of the implantable pump for the long-term basis (paragraph 0005).
Regarding claim 197, Thierfelder discloses wherein the drug contained in the at least one second compartment is in powder form (paragraph 0038, lines 2-5, “solid powder”).
Regarding claims 199 and 216, Thierfelder discloses the claimed invention substantially as claimed, as set forth above in claim 196. Thierfelder further discloses regarding presence of a plurality of second compartments in paragraph 0035 but is silent regarding the particulars of the number of the second compartments is 50 or more or particular 100 or more.
There is no evidence of record that establishes that changing the number of the second compartments would result in a difference in function of Thierfelder device. Further, a person having ordinary skill in the art, being faced with modifying the number of the second compartments of Thierfelder would have a reasonable expectation of success in making such a modification and it appears that device would function as intended being given the claimed number of the second compartments. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the number of the second compartments of Thierfelder to have the number of the second compartments to be 50 or more or 100 or more as an obvious matter of design choice within the skill of the art.
Regarding claim 200, Thierfelder discloses wherein the at least one second compartments 36 is liquid-tightly sealed against the at least one first compartment (paragraph 0034, lines 4-6, paragraph 0039, lines 1-2, “has an internal moisture content near zero” indicates that the plurality of the second compartments is liquid-tightly sealed against the at least one first compartment), wherein the system further comprises a mechanism (paragraph 0039, lines 2-5, “input valve”, paragraph 0037, mechanism that allows rotation of element 34) for individually opening a connection between the second compartments and the at least one first compartment.
Regarding claim 201, Thierfelder discloses wherein the second compartments 36 are mounted so as to open towards a first side (side where element 36 are present) of a plate (see “P” in figure 2 below) and wherein the mechanism is adapted to act on the second compartments so as to open to said first side of the plate (paragraph 0039, lines 2-5, “input valve”).
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Regarding claim 202, Thierfelder discloses wherein the second compartments 36 are mounted in the plate as displaceable drug containers and the mechanism is adapted to displace the drug containers such that they deliver their drug contents (paragraph 0037).
Regarding claim 203, Thierfelder discloses wherein the second compartments 36 are mounted in a plate (see “P” in figure 2 above) which is rotatable (paragraph 0037) so as to allow drug containers to be brought into alignment with a conduit 11 upon rotation of the plate (paragraph 0041, lines 1-3).
Regarding claim 207, Thierfelder discloses a penis erection stimulation system 10 (figure 1), comprising a fully implantable drug delivery device (figure 1) for delivering a drug in relation to a penis to achieve erection of the penis (paragraph 0028) and at least one reservoir 36 (and compartment holding fluid stored underside of the element 12, paragraph 0039) adapted for implantation inside the patient's body to store the drug to be delivered,
wherein the reservoir comprises at least one first compartment (paragraph 0039, compartment holding fluid stored underside of element 12) accommodating or adapted to accommodate a first substance (paragraph 0039) and at least one second compartment 36 accommodating or adapted to accommodate a second substance (paragraph 0038, lines 1-2),
wherein the at least one first compartment accommodates or is adapted to accommodate an infusion liquid (paragraph 0039) and the at least one second compartment accommodates or is adapted to accommodate a drug (paragraph 0038, lines 1-2) for mixing with the infusion liquid of the first compartment. Thierfelder is silent regarding wherein at least a section of a periphery of the at least one first compartment is made from a flexible material permitting volume changes of the first compartment by deformation of the flexible material as the infusion liquid is filled into or drawn out of the at least one first compartment.
However, Forsell teaches a design of a fully implantable penis erection stimulation system (figure 1 with embodiment shown in figure 6) wherein a section of a periphery of the at least one first compartment “R” (figure 6) is made from a flexible material 60 permitting volume changes of the first compartment by deformation of the flexible material as the infusion liquid is filled into or drawn out of the at least one first compartment (paragraph 0082) for the purpose of using a well-known alternative design of the first compartment in storing and releasing the fluid when needed (paragraph 0082).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the at least one first compartment of Thierfelder to incorporate wherein at least a section of a periphery of the at least one first compartment is made from a flexible material permitting volume changes of the first compartment by deformation of the flexible material as the infusion liquid is filled into or drawn out of the at least one compartment as taught by Forsell for the purpose of using a well-known alternative design of the first compartment in storing and releasing the fluid when needed (paragraph 0082).
Regarding claim 208, Thierfelder is silent regarding wherein the flexible material comprises a polymer membrane.
However, Forsell teaches wherein the flexible material 60 comprises a polymer membrane (paragraph 0021, lines 5-6) for the purpose of allowing the deformation needed to change the volume of the reservoir during filling or delivering the fluid (paragraph 0021).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the reservoir of Thierfelder to incorporate wherein the flexible material comprises a polymer membrane as taught by Forsell for the purpose of allowing the deformation needed to change the volume of the reservoir during filling or delivering the fluid (paragraph 0021).
Regarding claim 209, Thierfelder is silent regarding wherein the system is configured to draw infusion liquid from the at least one first compartment such that a negative pressure in at least part of the reservoir.
However, Forsell teaches wherein the system (figure 1) is configured to draw infusion liquid from the at least one first compartment such that a negative pressure in at least part of the reservoir (paragraphs 0022, 0078) for the purpose of allowing the reservoir to allow the fluid to flow out of the reservoir (paragraphs 0022, 0078).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the reservoir of Thierfelder to incorporate wherein system is configured to draw infusion liquid from the at least one first compartment such that a negative pressure in at least part of the reservoir as taught by Forsell for the purpose of allowing the reservoir to allow the fluid to flow out of the reservoir (paragraphs 0022, 0078).
Regarding claim 210, Thierfelder is silent regarding wherein the at least one first compartment comprises a gas chamber and an infusion liquid chamber, said chambers being separated by the polymer membrane.
However, Forsell teaches wherein the at least one first compartment comprises a gas chamber and an infusion liquid chamber, said chambers being separated by the polymer membrane for the purpose of using a well-known alternative design of the first compartment in storing and releasing the fluid when needed (paragraph 0082).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the reservoir of Thierfelder to incorporate wherein the at least one first compartment comprises a gas chamber and an infusion liquid chamber, said chambers being separated by the polymer membrane as taught by Forsell for the purpose of using a well-known alternative design of the first compartment in storing and releasing the fluid when needed (paragraph 0082).
Regarding claim 211, Thierfelder is silent regarding wherein the reservoir has an injection port for refilling the reservoir with infusion liquid.
However, Forsell teaches wherein the reservoir “R” has an injection port 61 for refilling the reservoir with infusion liquid (paragraph 0082, lines 6-8) for the purpose of refilling the implanted reservoir when needed (paragraph 0082, lines 6-8, paragraph 0024).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claim3ed invention to modify the reservoir of Thierfelder to incorporate wherein the reservoir has an injection port for refilling the reservoir with infusion liquid as taught by Forsell for the purpose of refilling the implanted reservoir when needed (paragraph 0082, lines 6-8, paragraph 0024).
Regarding claim 212, Thierfelder is silent regarding wherein the injection port comprises a material which is self-sealing in respect of penetrations caused by a replenishing needle.
However, Forsell teaches wherein the injection port 61 comprises a material which is self-sealing in respect of penetrations caused by replenishing needle (paragraph 0024) for the purpose of easily accessing to refill without any leakage (paragraph 0024).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the reservoir of Thierfelder to incorporate wherein the injection port comprises a material which is self-sealing in respect of penetrations caused by replenishing needle as taught by Forsell for the purpose of easily accessing to refill without any leakage (paragraph 0024).
Regarding claim 213, Thierfelder is silent regarding wherein the injection port is adapted for subcutaneous implantation.
However, Forsell teaches wherein the injection port 61 is adapted for subcutaneous implantation (paragraph 0024) for the purpose of easily accessing to refill the reservoir when needed (paragraph 0024).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the system of Thierfelder to incorporate wherein the injection port is adapted for subcutaneous implantation as taught by Forsell for the purpose of easily accessing to refill the reservoir when needed (paragraph 0024).
Regarding claim 215, Thierfelder discloses further comprising the at least one pump (paragraph 0057) adapted for implantation inside the patient’s body to advance the drug from the reservoir to the drug delivery device.
Claim 198 is rejected under 35 U.S.C. 103 as being unpatentable over Thierfelder et al. (US 2004/0034338 A1) in view of Forsell (US 2007/0233019 A1) and further in view of Ross (GB 2229374 A).
Regarding claim 198, Thierfelder/Forsell (hereinafter referred as “modified Thierfelder”) discloses the claimed invention substantially as claimed, as set forth above in claim 196. Modified Thierfelder is silent regarding wherein the drug contained in the at least second compartment is in freeze-dried form.
However, Ross teaches a design of a two-compartment mixing apparatus (figure 1) comprising a drug 25 wherein the drug contained in the at least second compartment 18 for the purpose of extending the storage life of the drug (page 1, lines 8-10).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the drug of modified Thierfelder to incorporate freeze-dried drug as taught by Ross for the purpose of extending the storage life of the drug (page 1, lines 8-10).
Claims 204-206 are rejected under 35 U.S.C. 103 as being unpatentable over Thierfelder et al. (US 2004/0034338 A1) in view of Forsell (US 2007/0233019 A1) and further in view of McGinn et al. (US 6,752,148 B1).
Regarding claims 204 and 205, modified Thierfelder discloses the claimed invention substantially as claimed, as set forth above in claims 196 and 200. Thierfelder is silent regarding the second compartments are mounted on a tape wound up on a reel wherein the tape is contained in a replaceable cassette.
However, McGinn teaches a design of a cassette (figure 14) for use in a drug delivery device wherein the second compartments 195 are mounted on a tape 182 wound up on a reel 176 wherein the tape is contained in a replaceable cassette 170 (element 170 could be replaced with an identical one) for the purpose of dispensing an accurate drug dosage (column 2, lines 23-24).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the second compartments of Thierfelder to incorporate the second compartments are mounted on a tape wound up on a reel wherein the tape is contained in a replaceable cassette as taught by McGinn for the purpose of dispensing an accurate drug dosage (column 2, lines 23-24).
Regarding claim 206, Thierfelder discloses the claimed invention substantially as claimed, as set forth above in claims 196 and 200. Thierfelder is silent regarding wherein a plurality of second compartments is arranged on the tape in a side-by-side relationship in a direction different to a winding direction of the tape.
However, McGinn teaches wherein a plurality of second compartments 195 is arranged on the tape 182 in a side-by-side relationship in a direction (see “D” in figure 14 below) different to a winding direction (see “WD” in figure 14 below) of the tape for the purpose of dispensing an accurate drug dosage (column 2, lines 23-24).
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Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify a plurality of second compartments as taught by Thierfelder to incorporate wherein a plurality of second compartments is arranged on the tape in a side-by-side relationship in a direction different to a winding direction of the tape as taught by McGinn for the purpose of dispensing an accurate drug dosage (column 2, lines 23-24).
Claim 214 is rejected under 35 U.S.C. 103 as being unpatentable over Thierfelder et al. (US 2004/0034338 A1) in view of Forsell (US 2007/0233019 A1) and further in view of Heruth et al. (US 8,043,281) and Swenson (US 5,108,372).
Regarding claim 214, Thierfelder/Forsell (hereinafter referred as “modified Thierfelder”) discloses the claimed invention substantially as claimed, as set forth above in claim 207. Modified Thierfelder is silent regarding further comprising a cooling device for keeping the content within at least one first compartment or the at least one second compartment of the reservoir at a temperature below 370C.
However, such cooling device would have been considered conventional in the art at the time the invention was made as evidenced by the teachings of Heruth and Swenson.
Heruth discloses an implantable apparatus having a thermal control device 662 (figure 9) and further states that thermal control device adjusts the temperature of the drug solution prior to delivery to the catheter (column 24, lines 4-16).
Furthermore, Swenson teaches that fluid temperature upon entering the body is 20 degrees centigrade or cooler (column 1, lines 14-15).
Based on the evidence above, for an artisan skilled in the art, modifying the system disclosed by modified Thierfelder with a colling device, as taught by Heruth, would have been considered obvious in view of the demonstrated conventionality of using colling mechanisms in implantable devices. Moreover, an artisan skilled in the art would have been motivated to make the modification because Heruth explicitly states that temperature of a drug prior to infusion affects drug distribution in the body (column 24, lines 4-6) and Swenson explicitly states that in surgery and after extreme trauma, fluids are infused into patients at a temperature of 20 degrees centigrade or cooler and moreover that the cooling of drugs prevents incubation of harmful organisms in the fluid media (column 1, lines 14-17).
Thus, modified Thierfelder modified in view of Heruth and Swenson teaches further comprising a cooling device for keeping the content within at least one compartment of the reservoir at a temperature below 370C.
Response to Arguments
Applicant's arguments filed 11/19/2025 have been fully considered but they are not persuasive.
Applicant argues on page 3, line 1-page 6, last line that the combination of Thierfelder et al. (US 2004/0034338 A1) in view of Forsell (US 2007/0233019 A1) does not render applicant’s claims obvious because such modified reference would not have disclosed or suggested all of the limitations rejected under 103(a). Furthermore, applicant argues that examiner must rely on concrete evidence to provide factual record that supports a determination that the rejected claims are not patentable because they are obvious over cited prior art instead of providing merely a conclusory statement. Examiner respectfully disagrees. According to MPEP 1504.03, examiner has followed the guidelines set forth by Supreme court in Graham V. John Deere Co. in evaluation of design patentability including determining the scope and content of the prior art, ascertaining the differences between the claimed invention and the prior art, resolving the level of ordinary skill in the art and determining prima facie obviousness by providing the motivation. Even though Forsell does not disclose the implantable penis erection stimulation system, the device of Forsell could be used as an implantable penis erection stimulation system. Furthermore, Forsell was used for modification of the compartment of Thierfelder therefore, even if for the purpose of argument, Forsell does not disclose the implantable penis erection stimulation system, Forsell does disclose an implantable system. One of ordinary skill in the art could utilize the well-known compartment structure from a generic implantable system into the implantable penis erection stimulation system. Accordingly, the rejection is proper.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783