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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09 March 2026 has been entered.
Claims 1 and 3-21 are currently under consideration. The Office acknowledges the amendments to claims 1, 11, 12, 16, and 18-20.
Claim Objections
Claims 3-5 and 18 are objected to because of the following informalities:
In claim 3, line 1: “lumen” should apparently read --the lumen--.
In claim 3, line 2: “second portion” should apparently read --a second portion--.
In claim 4, line 4: “begin” should apparently read --being--.
In claim 5, line 4: “begin” should apparently read --being--.
In claim 18, line 3: “having an outer surface having an outer surface” should apparently read --having an outer surface--.
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 6, 7, 14, and 21 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 6 recites the limitation "the outer surface of the inflatable member" in line 1. There is insufficient antecedent basis for this limitation in the claim; an outer surface of the sidewall has been previously recited, but not an outer surface of the inflatable member.
Claim 7 recites the limitation "the outer surface of the inflatable member" in line 1. There is insufficient antecedent basis for this limitation in the claim; an outer surface of the sidewall has been previously recited, but not an outer surface of the inflatable member.
Claim 14 recites the limitation "a reservoir" in line 2. It is not clear if this is intended to be the same reservoir recited in claim 1 or to be a separate reservoir.
Claim 14 also recites the limitation "the pump" in line 3. There is insufficient antecedent basis for this limitation in the claim; only a pump assembly has been previously recited
Claim 14 also recites the limitation "a transfer" in line 3. It is not clear if this is intended to be the same transfer recited in claim 1 or to be a separate transfer.
Claim 21 recites the limitation "the second portion" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 also recites the limitation "the length" in line 2. 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.
Claims 1, 3-6, 10-14, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lund et al. (U.S. Pub. No. 2014/0309490 A1; hereinafter known as “Lund”).
Regarding claim 1, Lund discloses an implant (Abstract; Figs. 1, 12), comprising: an inflatable member 102 and a pump assembly 104 configured to facilitate a transfer of a fluid from a reservoir 106 to the inflatable member ([0036]-[0037])), the inflatable member having a sidewall that defines a lumen 122, the sidewall having an outer surface 114 and an inner surface 116/126 disposed opposite the outer surface, at least a portion of the lumen having a spiral shape ([0042]; [0047]; [0067]).
Regarding claim 3, Lund discloses that the lumen defined by the sidewall of the
inflatable member includes a first portion having a first diameter and second portion having a second diameter, the second diameter being larger than the first diameter ([0072]; e.g., a first portion may have a first diameter in an uninflated condition, a second portion may have a second, larger diameter in an inflated condition).
Regarding claim 4, Lund discloses that the lumen defined by the sidewall of the
inflatable member includes a first portion having a first diameter, a second portion having a second diameter, and a third portion having a third diameter, the second portion being disposed between the first portion and the third portion, the second diameter begin larger than the first diameter, the second diameter being larger than the third diameter ([0072]; e.g., a first portion towards a proximal end may have a first diameter in an uninflated condition, a third portion towards a distal end may have a third diameter in an uninflated condition, and a second portion in the middle may have a second, larger diameter in an inflated condition).
Regarding claim 5, Lund discloses that the lumen defined by the sidewall of the
inflatable member includes a first portion having a first diameter, a second portion having a second diameter, and a third portion having a third diameter, the second portion being disposed between the first portion and the third portion, the second diameter begin larger than the first diameter, the second diameter being larger than the third diameter, the second portion being disposed between the first portion and the third portion along a longitudinal axis of the inflatable member ([0072]; e.g., a first portion towards a proximal end may have a first diameter in an uninflated condition, a third portion towards a distal end may have a third diameter in an uninflated condition, and a second portion in the middle may have a second, larger diameter in an inflated condition).
Regarding claim 6, Lund discloses that the outer surface of the inflatable member is substantially smooth (Fig. 1; [0036]; [0040]).
Regarding claim 10, Lund discloses that the inflatable member is configured to be placed in an inflated configuration and a deflated configuration ([0036]-[0037]).
Regarding claim 11, Lund discloses that the inflatable member is configured to be placed in an inflated configuration or a deflated configuration, the inflatable member having a tubular shape when in the deflated configuration (Fig. 1; [0036]-[0037]).
Regarding claim 12, Lund discloses that the inflatable member is configured to be placed in an inflated configuration or a deflated configuration, the inflatable member configured to extend along a longitudinal axis when placed in the inflated configuration (Fig. 1; [0036]-[0037]).
Regarding claim 13, Lund discloses a first cap 120 coupled to a first end portion of the inflatable member and a second cap 118 coupled to a second end portion of the inflatable member ([0039]).
Regarding claim 14, Lund discloses a reservoir 106 configured to retain the fluid, wherein the pump is configured to help facilitate a transfer of the fluid from the reservoir to the inflatable member when the implant is in an inflation mode ([0037]).
Regarding claim 21, Lund discloses that the second portion of the lumen extends linearly along the length of the inflatable member ([0067]).
Claim Rejections - 35 USC § 103
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.
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.
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lund as applied to claim 1 above, and further in view of Kuyava (U.S. Pub. No. 2009/0105530 A1). Lund discloses the invention as claimed, see rejection supra, but fails to disclose that the outer surface of the inflatable member includes a series of undulations. Kuyava discloses a similar implant (Abstract) comprising an inflatable member with an outer surface that includes a series of undulations in order to allow for a smaller deflated state without a smaller inflated state, allowing easier installation and providing greater comfort ([0016]-[0020]; [0028]). It would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to modify the invention of Lund with a series of undulations on the outer surface of the inflatable member, as taught by Kuyava, in order to allow easier installation and provide greater comfort.
Claims 8 and 9 rejected under 35 U.S.C. 103 as being unpatentable over Lund as applied to claim 1 above, and further in view of Morningstar (U.S. Pub. No. 2012/0053401 A1). Lund discloses the invention as claimed, see rejection supra, but fails to disclose that the inflatable member is unitarily formed or is monolithic. Morningstar discloses a similar implant (Abstract) comprising an inflatable member that is unitarily formed and monolithic in order to integrally form a one-piece unit ([0026]-[0029]). It would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to modify the invention of Lund so that the inflatable member that is unitarily formed and monolithic, as taught by Morningstar, in order to integrally form a one-piece unit.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Lund as applied to claim 1 above, and further in view of Taylor (U.S. Pub. No. 2017/0027696 A1). Lund discloses the invention as claimed, see rejection supra, but fails to disclose that the pump assembly includes a valve body and a pump bulb member (though Fig. 1 appears to show a pump bulb). Taylor discloses a similar implant (Abstract) comprising a pump assembly that includes a valve body and a pump bulb member in order to control fluid flow for inflation/deflation ([0036]; [0065]). It would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to modify the invention of Lund with a valve body and a pump bulb member, as taught by Taylor, in order to control fluid flow for inflation/deflation.
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kubalak et al. (U.S. Pub. No. 2017/0065419 A1; hereinafter known as “Kubalak”), in view of George et al. (U.S. Pub. No. 2009/0132044 A1; hereinafter known as “George”).
Regarding claim 16, Kubalak discloses an apparatus (Abstract; Figs. 1-3), comprising: a core member 40/70 for forming an elongate member of a bodily implant, the core member having a longitudinal axis and an outer surface ([0048]), the core member being formed of a material that is configured to dissolve ([0040]; [0043]; [0046]; [0075]); and a tubular member 28 defining a lumen configured to receive at least a portion of the core member ([0034]; [0039]). Kubalak fails to disclose that the outer surface having a series of undulations, but does teach that the core member improves the implantation procedure ([0039]). George discloses a similar apparatus (Abstract; Figs. 1-3) that comprises a core member 100 with an outer surface having a series of undulations 110/112/114/118/120/122 in order to require less force to bend and reduce springback ([0007]; [0010]-[0014]). It would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to modify the invention of Kubalak so that the outer surface of the core member has a series of undulations, as taught by George, in order to require less force to bend and reduce springback, thus further easing implantation.
Regarding claim 17, the combination of Kubalak and George discloses the invention as claimed, see rejection supra, and Kubalak further discloses that the core member defines a lumen 74, the lumen extends substantially parallel to the longitudinal axis of the core member (Figs. 3A-B; [0048]).
Regarding claim 18, Kubalak discloses a method of making an elongate member for a bodily implant (Abstract; Figs. 1-3), comprising: forming a core member 40/70 having an outer surface ([0040]; [0043]; [0046]; [0048]); disposing the core member within a lumen of a tubular member 28 ([0034]; [0039]); placing material within the lumen of the tubular member and removing the core member from the tubular member ([0040]; [0043]; [0046]; [0048]; [0052]). Kubalak fails to disclose that the outer surface having a series of undulations, but does teach that the core member improves the implantation procedure ([0039]). George discloses a similar apparatus (Abstract; Figs. 1-3) that comprises a core member 100 with an outer surface having a series of undulations 110/112/114/118/120/122 in order to require less force to bend and reduce springback ([0007]; [0010]-[0014]). It would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to modify the invention of Kubalak so that the outer surface of the core member has a series of undulations, as taught by George, in order to require less force to bend and reduce springback, thus further easing implantation.
Regarding claim 19, the combination of Kubalak and George discloses the invention as claimed, see rejection supra, and Kubalak further discloses that the core member is formed of a material that is configured to dissolve ([0040]; [0043]; [0046]; [0048]; [0052]).
Regarding claim 20, the combination of Kubalak and George discloses the invention as claimed, see rejection supra, and Kubalak further discloses that the removing the core member from the tubular member includes dissolving the core member ([0040]; [0043]; [0046]; [0048]; [0052]).
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 16 and 18-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-12 of U.S. Patent No. 11,324,595. Although the claims at issue are not identical, they are not patentably distinct from each other because they recite essentially identical limitations such that they would not meet a one-way test for distinctness. The claims of the issued patent include the limitations of present claim 16 (reciting such a core member with a longitudinal axis and outer surface with a series of undulations, which can dissolve, and a tubular member with a lumen that receives the core member; the casing is taken to be such a tubular member) and claims 18-20 (reciting such a core member with a longitudinal axis and outer surface with a series of undulations, the core member disposed within a tubular member with a lumen; the casing is taken to be such a tubular member; as the core member is formed of a material that is configured to dissolve and is dissolved, this is taken to include placing material within the lumen as some sort of fluid must be introduced so that the material can dissolve).
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 112 have been fully considered and are persuasive in light of the amendments. The rejections have been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Phelan et al. (U.S. Pub. No. 2014/0142666 A1) and Newman (U.S. No. 4,881,939) each teach implants with inflatable members and pumps, wherein the inflatable member has a lumen with a spiral shape. It is noted that neither of these references would be applicable to the present invention if the present invention was limited to a penile prosthesis instead of a generic implant.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M. Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791
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