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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the limitations of claim 5 must be shown or the feature(s) canceled from the claim(s). Claim 1 recites the elongate member having a storage portion and an inflatable portion. Claim 5 recites a second elongate member having an inflatable portion, wherein the pump assembly transfers fluid from the storage portion to the inflatable portion of the second member. As written, the claims 1 and 5 recite that the second elongate member shares the storage portion within the elongate member of claim 1. Figures 5 and 6 appear to show the intended limitations of claim 5, but the storage portion is external to the elongate member.
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 10, 11 and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moon (WO 2015093681 A1).
Regarding claim 1, Moon discloses an implantable inflatable device (Abstract), comprising:
an elongate member (Figure 2, “100”) having a storage portion (Figure 2, “10”) and an inflatable portion (Figure 2, “20”); and a pump assembly operatively coupled to the elongate member and configured to transfer fluid from the storage portion of the elongate member to the inflatable portion of the elongate member (Figure 2, “50”).
Regarding claim 2, Moon discloses the storage portion is fluidically coupled to the inflatable portion (Figure 2), the elongate member includes a flow control member disposed between the storage portion and the inflatable portion (Figure 2, “50”, the pump functions as the flow control member).
Regarding claim 3, Moon discloses the storage portion is fluidically coupled to the inflatable portion (Figure 2), the elongate member includes a flow restrictor or a valve disposed between the storage portion and the inflatable portion (Figure 2, “50”, the pump functions as the flow restrictor and comprises check valves (Figure 3)).
Regarding claim 4, Moon discloses the elongate member is a first elongate member (Figure 9), the device further comprising: a second elongate member (Figure 9) having a storage portion (Figure 9) and an inflatable portion (Figure 9), the pump assembly (Figure 9, the “pump assembly” can be interpreted as the set of pumps in each elongate member) being operatively coupled to the second elongate member and configured to transfer fluid from the storage portion of the second elongate member to the inflatable portion of the second elongate member (Figure 9).
Regarding claim 5, Moon discloses the elongate member is a first elongate member (Figure 9), the device further comprising: a second elongate member (Figure 9) having an inflatable portion (Figure 9), the pump assembly (Figure 9, the “pump assembly” can be interpreted as the set of pumps in each elongate member) being operatively coupled to the second elongate member and configured to transfer fluid from the storage portion to the inflatable portion of the second elongate member (Figure 9, the limitations require the pump assembly to be configured to transfer fluid from the storage portion to the inflatable portion. As the pump assembly is configured to transfer fluid from one location to another, it would read on the limitations, regardless of the origination point of the fluid).
Regarding claim 10, Moon discloses the pump assembly is operatively coupled to the elongate member via a tubular member (Figure 2, “31”, “41”).
Regarding claim 11, Moon discloses the pump assembly is operatively coupled to the storage portion of the elongate member via a single tubular member (Figure 2, “41”).
Regarding claim 13, Moon discloses the elongate member is configured to be disposed within a penis of a patient (Abstract).
Regarding claim 14, Moon discloses the elongate member and the pump assembly are configured to be disposed within a pelvic region of a patient (Abstract).
Regarding claim 15, Moon discloses the pump assembly is configured to be operatively coupled to a controller (Figure 19, control device “40B”).
Claim(s) 16, 17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fogarty (US 20110201880 A1).
Regarding claim 16, Fogarty discloses an implantable inflatable device (Abstract), comprising: an elongate member having an inflatable portion (Figure 1, “4”); a pump assembly operatively (Figure 1, “5”) coupled to the elongate member via a tubular member (Figure 1), the tubular member being configured to house fluid (Figure 1), the pump assembly being configured to transfer fluid from the tubular member to the inflatable portion of the elongate member (Figure 1).
Regarding claim 17, Fogarty discloses the tubular member includes a first portion having a first size and a second portion having a second size, the second size being larger than the first size (Figure 1, any of the portions of the connections can be defined as the first or second portion, wherein the second portion can be selected based upon being a longer portion than a first portion in Figure 1).
Regarding claim 19, Fogarty discloses a first and second elongate member (Figure 5).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Moon (WO 2015093681 A1) in view of Marconi Toro (WO 2021203212 A1).
Regarding claims 6-8, Moon does not disclose an adjustable portion. Marconi Toro discloses a prosthetic device for implantation within the corpora cavernosa of a penis (Abstract), wherein the distal end of the prosthetic comprises a shortenable anchoring rod (Abstract), wherein the storage portion is disposed between the adjustable portion and the inflatable portion (Figure 2, adjustable portion “600”, storage portion “700”, inflatable portion “10”), with the adjustable portion being configured to be cut to adjust a size of the adjustable portion (Page 10, last paragraph) and the adjustable portion including visual indicia (Page 10, last paragraph). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device as taught by Moon, with the adjustable distal end as taught by Marconi Toro, since such a modification would provide the predictable results of allowing the device to be trimmed to fit the needs of the patient (Page 11).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Moon (WO 2015093681 A1) in view of Borgaonkar (US 20120157764 A1).
Regarding claim 9, Moon does not disclose an adjustable portion. Borgaonkar discloses an implantable penile prosthesis having an adjustable length rear tip extender (Abstract) wherein the adjustable extender comprises a plurality of pieces configured to be removably coupled to each other (Paragraph [0026]. Figures 5-6). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device as taught by Moon, with the adjustable length rear tip extender as taught by Borgaonkar, since such a modification would provide the predictable results of “insuring the implantable penile prosthesis is properly fitted and positioned within the penis according to the specific anatomy of the male patient” (Paragraph [0003]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Moon (WO 2015093681 A1) in view of Juenemann (DE 19814016 A1).
Regarding claim 12, Moon discloses the elongate member is a first elongate member (Figure 9), the device further comprising: a second elongate member (Figure 9), the pump assembly being operatively coupled to the first elongate member and the second elongate member (Figure 9, the “pump assembly” can be interpreted as the set of pumps in each elongate member). Moon does not disclose the pump assembly being operatively coupled to the first elongate member and the second elongate member via a Y shaped tubular member. Juenemann discloses a penile implant (Page 1) that comprises two cylinders that are operatively coupled to the pump assembly via a Y shaped tubular member (Figure 1). If a clinician was looking to simplify the system of Moon, they would remove the pump assembly from inside the elongate member and drive the elongate members by a single pump, as Juenemann discloses it is easier to replace the single pump (Page 2). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device as taught by Moon, with the pump assembly being operatively coupled to the first elongate member and the second elongate member via a Y shaped tubular member as taught by Juenemann, since such a modification would provide the predictable results of increasing the maintainability of the device by reducing the number of replaceable parts (Juenemann, Page 2).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Fogarty (US 20110201880 A1).
Regarding claim 18, Fogarty discloses in Figure 3, the tubular member includes a first portion having a first size, a second portion having a second size, and a third portion having a third size (any of the tubular sections can be defined as the first, second or third portion). Fogarty does not explicitly disclose the second size being larger than the first size and larger than the third size, the second portion being disposed between the first portion and the third portion. As the claim does not require the size to be a specific dimension (diameter or length), and the criticality of the size is not cited by the claims or specification, a POSITA could arrive at the limitations of claim 18 by design choice or design optimization. An example would be annotated Figure 1 below, wherein Examiner selected portions of the tubular member that read on the limitations. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device as taught by Fogarty, with tubular members of various sizes that read on the limitations of the claim in an effort to optimize the design of the device.
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Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Fogarty (US 20110201880 A1) in view of Forsell (US 20120022324 A1).
Regarding claim 20, Fogarty does not disclose the pump assembly is configured to be wirelessly coupled to a controller. Forsell discloses penile implant (Abstract) wherein the pump is wirelessly controlled via a wireless remote (Paragraph [0355]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device as taught by Fogarty, with the pump assembly being configured to be wirelessly coupled to a controller as taught by Forsell, since such a modification would provide the predictable results of reducing the user’s need to manipulate the implanted device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Riemer (DE 19903246 A1) and Helmy (US 5437605 A) disclose elongate members having a pump, a storage portion and an inflatable portion.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marc D Honrath whose telephone number is (571)272-6219. The examiner can normally be reached M-F 7:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.D.H./Examiner, Art Unit 3791