Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Reissue Applications
Applicant is reminded of the continuing obligation under 37 CFR § 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which US Pat. No. 8,900,322 (“the ‘322 patent”) is or was involved. These proceedings would include interferences, reissues, reexaminations and litigations.
Applicant is further reminded of the continuing obligation under 37 CFR § 1.56 to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Maintenance Fees
Review of the file indicates that applicant’s window for the 11.5 year maintenance fee for the ‘322 patent without surcharge will opened 02 December 2025 and will close 02 June 2026. Payment of the maintenance fee with surcharge begins 03 June 2026 and will close 02 December 2026. If the last day for paying a maintenance fee with or without surcharge falls on a Saturday, Sunday, or a federal holiday within the District of Columbia, the fee plus surcharge if applicable may be paid on the next succeeding day which is not a Saturday, Sunday or federal holiday. Applicant is encouraged to ensure all payments are current and proper. See 37 CFR §1.362(d) and (e).
As per MPEP §2504(I)(B),
Effective January 16, 2018, the original patent requires a separate maintenance fee payment if at least one reissue application based on the original patent is pending on the maintenance fee due date (i.e., the 3½, 7½, or 11½ year date) even if a maintenance fee payment is made in reissue patent(s) that have issued from the same original patent.
35 U.S.C. 251 permits reissue only for "the unexpired part of the term of the original patent." An original patent is not surrendered under 35 U.S.C. 252 until a reissue application, based on the original patent, issues as a reissue patent and no other reissue application, based on the same original patent, is still pending. Because it is the granting of the reissue patent – and not the filing of the reissue application - that effectuates surrender of the original patent under 35 U.S.C. 252, maintenance fees remain due in the original patent whenever an application for reissue of the original patent is pending on the maintenance fee due date. Specifically, when one or more reissue patents have issued and at least one application for reissue of the same original patent remains pending, the original patent is not surrendered and maintenance fees remain due in the original patent until the last remaining reissue application issues as a reissue patent or becomes abandoned. In other words, while there is an application for reissue pending in a reissue patent family, maintenance fee payments will be required in both the original patent and the corresponding reissue patent(s). (emphasis added).
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Applicant is reminded that maintenance fees are required in both the original ‘322 patent and reissue patent Nos. RE50,051; RE49,239; RE48,119; RE46,669 and RE46,283.
Specification
The amendment to the specification filed 06/12/2024 should be updated with reissue application 17/680,035 now being issued as RE50051.
Election/Restriction
This application contains claims directed to the following patentably distinct species
Figs. 3-5;
Fig. 6; and
Figs. 13-14.
It is noted that the selection of either species a) or b) will include Figs. 1-2 and 7-12. Species a), b) and c) are independent or distinct because they are mutually exclusive species. For instance, the embodiment of species a) or b) does not require the limitation of “a head.” Similarly, species c) does not require “a second intramedullary stem.” Further, species b) does not require “wherein each of said outermost surfaces of said plurality of fins is generally planar or smooth.” In addition, these species are not obvious variants of each other based on the current record.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: a search in at least A61F2/38 and A61F2/3836 required for species a) and b) is not required for species c); and a search in A61F2/32 for species c) is not required for species a) and b).
Since applicant has received a patent for the originally presented invention, species c), this invention has been constructively elected by original presentation for prosecution on the merits.
Accordingly, claims 11-13, 17, 20-25, 36-37, 41, 43-45, 49, 52-57 and 66-67 are withdrawn from consideration as being directed to a non-elected invention.
Claims 8-10, 14-16, 18-19, 26-35, 38-40, 42, 46-48, 50-51, 58-65 and 68-70 are examined below. See 37 CFR 1.142(b) and MPEP § 821.03.
35 U.S.C. 251
Improper Error
The reissue oath/declaration filed with this application uses the same errors as in previous continuation reissue from the ‘322 patent and is improper because it fails to identify an error being corrected by this continuation reissue application. See 37 CFR 1.175 and MPEP § 1414 II (D)(1). The error statement must be a new error statement supporting a continuation reissue since the original error from previous reissue applications are considered to have been corrected in the issuance of the previous reissue applications. As set forth in MPEP § 1414 II (D)(1),
Where a continuation reissue application is filed with a copy of the reissue oath/declaration from the parent reissue application, and the parent reissue application is not to be abandoned, the reissue oath/declaration should be accepted by the Office of Patent Application Processing (OPAP) without further evaluation, because it is an oath/declaration, albeit improper under 35 U.S.C. 251. The examiner should, however, reject the claims of the continuation reissue application under 35 U.S.C. 251 as being based on an oath/declaration that does not identify an error being corrected by the continuation reissue application, and should require a new oath/declaration that identifies a new error or a statement explaining compliance with 37 CFR 1.175(f)(2) if appropriate. If the same error corrected in the parent is also being corrected in the continuation reissue application, but the error is being corrected in a different way, a statement is needed to explain compliance with 37 CFR 1.175(f)(2) for a reissue application filed on or after September 16, 2012. For these applications, a petition under 37 CFR 1.183 is not needed. For a reissue application filed before September 16, 2012, a petition under 37 CFR 1.183 will be needed to waive pre-AIA 37 CFR 1.175(e) in order to rely on the same error identified in the parent but being corrected in a different way. See 37 CFR 1.175(f)(2) for reissue applications filed on or after September 16, 2012, and pre-AIA 37 CFR 1.175(e) for reissue applications filed before September 16, 2012. One of form paragraphs 14.01.01, 14.01.02, or 14.01.03 may be used.
Claims 8-10, 14-16, 18-19, 26-35, 38-40, 42, 46-48, 50-51, 58-65 and 68-70 are rejected as being based upon a defective reissue oath/declaration under 35 U.S.C. 251. See 37 CFR 1.175. The error statement provided in the Declaration filed 06/12/2024 identifies that the claim language causing the error in the ‘322 patent is the recitation of “An antibiotic delivery system…’ and is limited to distribute antibiotic” and also states that new claims 8 and 40 removes the feature of antibiotic delivery and thereby broadens the claims. However, some of the previous parent reissue applications also relied upon this error. Specifically, reissue application 14/817,103 contains an error statement in the Reissue Declaration filed 08/03/2015 that states “claim 1 recites ‘An antibiotic delivery system…’ and is limited to distribute the antibiotic.” Similarly, reissue application 15/336,472 contains an error statement in the Reissue Declaration filed 06/30/2017 that states “Claim 1 of U.S. Patent No. 8,900,322 recites ‘An antibiotic delivery system…’ and is limited to distribute the antibiotic. … Claims 8, 28 and 38 of the present reissue application have removed the feature of the delivery of fluid-borne antibiotics, thereby broadening the claims of the reissue application.” Likewise, the Reissue Declaration filed 02/11/2020 in reissue application 15/846,021 also states that the claim language causing the error in the ‘322 patent is the recitation of “An antibiotic delivery system…” It is noted that upon the issuance of RE46283, RE46669 and RE48119 this error was considered corrected.
Furthermore, the inclusion of an ellipsis in the error statement claim language renders it unclear as to exactly what claim language caused the error. Only one word from an original claim is needed to form the basis for a reissue application; however, this inclusion of an ellipsis makes it unclear if the error is in the claim language stated or other claim language from the claim but not included in the error statement. It is recommended that the new declaration error statement include claim language without an ellipsis.
It is also noted that the current error statement filed 06/12/2024 also indicates that claim language in original claim 4 caused an error. However, original claim 4 is directed to a method of treating an infected joint during a two-stage re-implantation of an orthopedic implant. New claims 8-10, 14-16, 18-19, 26-35, 38-40, 42, 46-48, 50-51, 58-65 and 68-70 are directed to a medical device and not a method. Further, it is noted that both reissue applications 16/911,303 and 17/680,035 provide the same error statement directed to original claim 4.
Additionally, the reissue oath/declaration filed with this application is defective (see 37 CFR § 1.175 and MPEP § 1414) because of the following: the basis for the reissue application as per the error statement filed on 06/12/2024 is an error directed to a subject matter surrendering limitation. See Recapture Rejection below.
As per MPEP 1412.02,
A reissue will not be granted to "recapture" claimed subject matter which was surrendered in an application to obtain the original patent. In re McDonald, 43 F.4th 1340, 1345, 2022 USPQ2d 745 (Fed. Cir. 2022); Greenliant Systems, Inc. v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Youman, 679 F.3d 1335, 102 USPQ2d 1862 (Fed. Cir. 2012); In re Mostafazadeh, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984); In re Wadlinger, 496 F.2d 1200, 181 USPQ 826 (CCPA 1974); In re Richman, 409 F.2d 269, 276, 161 USPQ 359, 363-364 (CCPA 1969); In re Willingham, 282 F.2d 353, 127 USPQ 211 (CCPA 1960).
See recapture rejection below. Therefore, claims 8-10, 14-16, 18-19, 26-35, 38-40, 42, 46-48, 50-51, 58-65 and 68-70 are rejected as being based upon a defective reissue declaration under 35 USC § 251 as set forth above. See 37 CFR § 1.175.
Applicant must provide a new signed Declaration with new error statement or a statement in compliance with 37 CFR 1.175(f)(2) explaining how the error is being corrected in a different way from any and all of the previous reissue applications. Applicant is also reminded that the error cannot be based on surrendered subject matter from the original patent application.
Failure to File a Continuing Application
As per MPEP 1412.01,
Where a restriction (or an election of species) requirement was made in an application and applicant permitted the elected invention to issue as a patent without filing a continuing application on the non-elected invention(s) or on non-claimed subject matter distinct from the elected invention, the non-elected invention(s) and non-claimed, distinct subject matter cannot be recovered by filing a reissue application. A reissue applicant’s failure to timely file a continuing application is not considered to be an error causing a patent granted on the elected claims to be partially inoperative by reason of claiming less than the applicant had a right to claim. Accordingly, this is not correctable by reissue of the original patent under 35 U.S.C. 251. See In re Watkinson, 900 F.2d 230, 14 USPQ2d 1407 (Fed. Cir. 1990); In re Weiler, 790 F.2d 1576, 229 USPQ 673 (Fed. Cir. 1986); In re Orita, 550 F.2d 1277, 1280, 193 USPQ 145, 148 (CCPA 1977); see also In re Mead, 581 F.2d 251, 198 USPQ 412 (CCPA 1978).
In this case, a restriction requirement was made in parent patent application no. 12/712,748 (“the ‘748 application”) which was mailed on 12/12/2011. Therefore, applicant is barred from pursuing another distinct invention from that which issued in the ‘322 patent. New claims 8-10, 14-16, 18-19, 26-35, 38-40, 42, 46-48, 50-51, 58-65 and 68-70 are broader than original claim 1, a device claim. Additionally, original claim 1 and its dependent claims are directed to the embodiment of Figs. 13 and 14. Therefore, the present reissue application cannot be used to pursue a different and distinct embodiment.
Original Patent
The following is a quotation of the first paragraph of 35 U.S.C. 251:
(a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.
MPEP 1412.01 states that the reissue claims must be for the same invention as that disclosed as being the invention of the original patent. MPEP 1412.01 further provides guidelines for determining whether the reissue claims are "for the invention disclosed in the original patent" as:
(A) the claims presented in the reissue application are described in the original patent specification and enabled by the original patent specification such that 35 U.S.C. 112, first paragraph is satisfied; and
(B) nothing in the original patent specification indicates an intent not to claim the subject matter of the claims presented in the reissue application.
The presence of some disclosure (description and enablement) in the original patent should evidence that applicant intended to claim or that applicant considered the material now claimed to be his or her invention.
Further, the Federal Circuit addressed the “original patent” requirement of 35 USC 251 in Antares Pharma, Inc. v. Medac Pharma Inc. and Medac GMBH, 771 F.3d 1354, 112 USPQ2d 1865 (Fed. Cir. 2014). In Antares the reissue claims covered embodiments of injection devices (not restricted to jet-injection devices) which the Applicant admitted was a different invention from what was originally claimed. Id. at 1356. The Federal Circuit adopted the Supreme Court's explanation of the “same invention” requirement as “if the original patent specification fully describes the claimed inventions, but not if the broader claims ‘are [] merely suggested or indicated in the original specification’ ”. Id. at 1359. The Federal Circuit further stated that although wording in 35 USC 251 was changed from “same invention” to “original patent” no change in substance was intended. Id. at 1360.
Based on Antares a review of the specification is necessary to determine whether the original specification adequately discloses the invention of the reissue claims. Like in Antares, the specification states that the “The wound may be covered with a polyurethane continuously connected porous sponge (for example, Granufoam manufactured by KCI). This porous sponge also occupies deep and superficial wound space. The incisional wound edges are then completely sewn over the negative pressure wound therapy sponge except for the area just large enough to allow a suction disk to be attached to the sponge.” See col. 10, l. 65 through col. 11, l. 5. However, the specification does not disclose that a source of negative pressure for removing fluid from said first medullary canal is part of the device of the ‘322 patent invention. Rather, the source of negative pressure and sponge is disclosed as being used in the overall method of using the device and treating the wound.
Like in Antares, the specification states that the “The wound may be covered with a polyurethane continuously connected porous sponge (for example, Granufoam manufactured by KCI).” See col. 10, l. 65 through col. 11, l. 1. However, the specification does not disclose that the porous sponge is part of the device of the ‘322 patent invention. Rather, the porous sponge is disclosed as being used in the overall method of using the device and treating the wound.
Therefore, claims 18-19, 38, 50-51 and 68 which are directed to a porous sponge do not satisfy the “original patent” requirement.
Like in Antares, the specification states that the “In the embodiment illustrated in FIGS. 14-15, the body 526 includes an inlet 520 and the femoral bead includes a separate inlet 521. Both inlets 520, 521 are in fluid communication with the source of fluid-borne antibiotic 116.” See col. 10, ll. 22-25. However, the ‘322 patent specification does not disclose “wherein said second channel is in fluid communication with said first inlet, such that when said first intramedullary stem is installed in said first medullary canal and said head is installed in said socket, infusion of a first fluid through said first inlet results in said first fluid infusing … via said second plurality of outlets into said socket.” Therefore, the ‘322 original patent disclosure does not support the second channel (channel communicating with inlet 521) in fluid communication with the first inlet resulting in fluid infusing via the second plurality of outlets into the socket. This claimed configuration is not supported by the figures and disclosure of the original ‘322 patent.
Therefore, claims 27 and 59 which are directed to a the second channel being in fluid communication with the first inlet do not satisfy the “original patent” requirement.
Claims 18-19, 27, 38, 50-51, 59 and 68 are rejected under 35 USC 251 for not claiming subject matter directed to the invention disclosed in the original patent.
Recapture
Claims 8-10, 14-16, 18-19, 26-35, 38-40, 42, 46-48, 50-51, 58-65 and 68-70 are rejected under 35 U.S.C. 251 as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based.
See Greenliant Systems, Inc. et al v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Shahram Mostafazadeh and Joseph O. Smith, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984). A broadening aspect is present in the reissue which was not present in the application for patent. The record of the application for the patent shows that the broadening aspect (in the reissue) relates to claimed subject matter that applicant previously surrendered during the prosecution of the application. Accordingly, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claim subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
As stated in M.P.E.P. § 1412.02,
In Clement, 131 F.3d at 1468-70, 45 USPQ2d at 1164-65, the Court of Appeals for the Federal Circuit set forth a three step test for recapture analysis. In North American Container, 415 F.3d at 1349, 75 USPQ2d at 1556, the court restated this test as follows:
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We apply the recapture rule as a three-step process:
(1) first, we determine whether, and in what respect, the reissue claims are broader in scope than the original patent claims;
(2) next, we determine whether the broader aspects of the reissue claims relate to subject matter surrendered in the original prosecution; and
(3) finally, we determine whether the reissue claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule.
In North American Container, the court cited Pannu, 258 F.3d at 1371, 59 USPQ2d at 1600; Hester, 142 F.3d at 1482-83, 46 USPQ2d at 1649-50; and Clement, 131 F.3d at 1468, 45 USPQ2d at 1164-65 as cases that lead to, and explain the language in, the North American Container recapture test.
Step 1: Broadening
New claim 8 does not include the claim limitations which were part of original patent claim 1 including:
“An antibiotic delivery system;”
“femoral;”
“adapted to be removably mounted;”
“femur;”
“a body having a proximate end and a distal end disposed remote from said proximate end;”
“with respect to each other;”
“said fins adapted to engage said medullary canal in a removably stable fashion;”
“a femoral head and a neck extending from said proximal end of said body and between said body and said femoral head;”
“disposed along the stem;” and
“said femoral head having a plurality of outlets and a channel extending between said at least one inlet and said plurality of outlets for delivering fluid-borne antibiotics from said at least one inlet to said plurality of outlets so as to distribute said antibiotic along said intramedullary canal and the socket of a hip joint in a controlled fashion.”
New claim 40 does not include the claim limitations which were part of original patent claim 1 including:
“An antibiotic delivery system;”
“femoral;”
“adapted to be removably mounted;”
“femur;”
“a body having a proximate end and a distal end disposed remote from said proximate end;”
“a plurality of fins;”
“with respect to each other so as to define valleys;”
“said fins adapted to engage said medullary canal in a removably stable fashion;”
“a femoral head and a neck extending from said proximal end of said body and between said body and said femoral head;”
“disposed along said stem and between an outer surface of one of said plurality of adjacent fins in said valleys;”
“a channel extending between said inlet and said plurality of outlets;” and
“said femoral head having a plurality of outlets and a channel extending between said at least one inlet and said plurality of outlets for delivering fluid-borne antibiotics from said at least one inlet to said plurality of outlets so as to distribute said antibiotic along said intramedullary canal and the socket of a hip joint in a controlled fashion.”
New claims 8 and 40 are each broader than original patent claim 1. Therefore step 1 of the three-step test is met for claims 8-10, 14-16, 18-19, 26-35, 38-40, 42, 46-48, 50-51, 58-65 and 68-70.
Step 2a: Surrendered Subject Matter
In the prosecution of US Application 13/759,239 (“the ‘239 application”), applicant amended independent claim 5 in an amendment filed 06/17/2014 (resulting in allowed claim 1) in order to make the claims patentable. The added limitations included,
“said body including a plurality of fins extending therealong and disposed in spaced angular relationship with respect to each other so as to define valleys that provide fluid flow spaces disposed between adjacent fins, said fins adapted to engage said medullary canal in a removably stable fashion;” and
“a plurality of outlets disposed along said stem and between the outer surface of one of said plurality of adjacent fins in said valleys and in fluid communication with said fluid flow spaces and a channel extending between said inlet and said plurality of outlets.”
Subsequent to this amendment, a Notice of Allowance was mailed 08/27/2014. The step of amending the claims in the Amendment of 06/17/2014 in order to put the claims in condition for allowance is the action that generated the surrender of claimed subject matter, i.e. the broader claim before the amendment is the surrendered subject matter. Therefore, the surrender generating limitations include “said body including a plurality of fins extending therealong and disposed in spaced angular relationship with respect to each other so as to define valleys that provide fluid flow spaces disposed between adjacent fins, said fins adapted to engage said medullary canal in a removably stable fashion;” and “a plurality of outlets disposed along said stem and between the outer surface of one of said plurality of adjacent fins in said valleys and in fluid communication with said fluid flow spaces and a channel extending between said inlet and said plurality of outlets.”
Additionally, applicant also stated in their response filed 06/17/2014, pp. 8-12 that with respect to claim 5,
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Therefore, the surrender generating limitations also include “an antibiotic delivery system;” and “a femoral intramedullary stem having a body.”
Step 2b: Broadening of the Surrender Generating Limitation
As indicated in Step 1, claim 8 was broadened with respect to original claim 1. In comparison with Step 2a, the surrender generating limitations (SGL) that were broadened in new claim 8 include:
“An antibiotic delivery system” since applicant argued the prior art did not teach this limitation (see quote from response filed 06/17/2014, pp. 8-12 reproduced above);
“femoral” since applicant argued the prior art did not teach this limitation (see quote from response filed 06/17/2014, pp. 8-12 reproduced above);
“femur” since applicant argued the prior art did not teach the limitation of “femoral” above (see SGL #2 above);
“with respect to each other” since this limitation was included and recited in both the claim amendment and arguments filed 06/17/2014;
“said fins adapted to engage said medullary canal in a removably stable fashion” since this limitation was included and recited in both the claim amendment and arguments filed 06/17/2014; and
“disposed along the stem” since this limitation was included and recited in both the claim amendment and arguments filed 06/17/2014.
As indicated in Step 1, claim 40 was broadened with respect to original claim 1. In comparison with Step 2a, the surrender generating limitations (SGL) that were broadened in new claim 40 include:
“An antibiotic delivery system” since applicant argued the prior art did not teach this limitation (see quote from response filed 06/17/2014, pp. 8-12 reproduced above);
“femoral” since applicant argued the prior art did not teach this limitation (see quote from response filed 06/17/2014, pp. 8-12 reproduced above);
“femur” since applicant argued the prior art did not teach the limitation of “femoral” above (see SGL #2 above);
“a plurality of fins” since this limitation was included and recited in both the claim amendment and arguments filed 06/17/2014;
“with respect to each other so as to define valleys” since this limitation was included and recited in both the claim amendment and arguments filed 06/17/2014;
“said fins adapted to engage said medullary canal in a removably stable fashion” since this limitation was included and recited in both the claim amendment and arguments filed 06/17/2014;
“disposed along said stem and between an outer surface of one of said plurality of adjacent fins in said valleys” since this limitation was included and recited in both the claim amendment and arguments filed 06/17/2014; and
“a channel extending between said inlet and said plurality of outlets” since this limitation was included and recited in both the claim amendment and arguments filed 06/17/2014.
Therefore, this is the claim language removed from claims 8 and 40 which resulted in the broadening of claims 8 and 40 and is the exact claim language or related claim language of the surrendered subject matter by applicant.
Therefore, step 2 of the three-step test is met for claims 8-10, 14-16, 18-19, 26-35, 38-40, 42, 46-48, 50-51, 58-65 and 68-70.
Step 3: Materially Narrowing and Avoiding Recapture
It is impermissible recapture for a reissue claim to be as broad as, or broader in scope than any claim that was canceled or amended in the original prosecution to define over the art. Claim scope that was canceled or amended is deemed surrendered and therefore barred from reissue. Clement, 131 F.3d at 1470, 45 USPQ2d at 1165. It must be determined whether the reissue claim omits or broadens any limitation that was added or argued during the original prosecution to overcome an art rejection. Such an omission in a reissue claim, even if it is accompanied by other limitations making the reissue claim narrower than the patent claim in other aspects, is impermissible recapture. Pannu, 258 F.3d at 1371-72, 59 USPQ2d at 1600. In any broadening reissue application, the examiner will determine, on a claim-by-claim basis, whether the broadening in the reissue application claim(s) relates to subject matter that was surrendered during the examination of the patent for which reissue is requested) by an amendment narrowing claim scope in order to overcome a rejection and/or argument relying on a claim limitation in order to overcome a rejection.
Below is a claim chart comparing new independent claim 8 and the SGLs of original patent claim 1 (claim 5 during prosecution of the ‘239 application).
Claim 8 (New)
Claim 1 (Original)
Comparison
“A medical device for treating infected tissue in a patient”
“An antibiotic delivery system”
New claim 8 is broader than patented claim 1; however, the new limitation of “medical device for treating infected tissue in a patient” does not materially narrow original claim 5 before the amendment resulting in patented claim 1.
“first”
“femoral”
New claim 8 is broader than patented claim 1; however, the new limitation of “first” does not materially narrow original claim 5 before the amendment resulting in patented claim 1.
“first”
“femur”
New claim 8 is broader than patented claim 1; however, the new limitation of “first” does not materially narrow original claim 5 before the amendment resulting in patented claim 1.
Limitation eliminated
“with respect to each other”
Entire recapture of surrendered subject matter.
Limitation eliminated
“said fins adapted to engage said medullary canal in a removably stable fashion”
Entire recapture of surrendered subject matter.
Limitation eliminated
“disposed along the stem”
Entire recapture of surrendered subject matter.
Below is a claim chart comparing new independent claim 40 and the SGLs of original patent claim 1 (claim 5 during prosecution of the ‘239 application).
Claim 40 (New)
Claim 1 (Original)
Comparison
“A medical device for treating infected tissue in a patient”
“An antibiotic delivery system”
New claim 8 is broader than patented claim 1; however, the new limitation of “medical device for treating infected tissue in a patient” does not materially narrow original claim 5 before the amendment resulting in patented claim 1.
“first”
“femoral”
New claim 8 is broader than patented claim 1; however, the new limitation of “first” does not materially narrow original claim 5 before the amendment resulting in patented claim 1.
“first”
“femur”
New claim 8 is broader than patented claim 1; however, the new limitation of “first” does not materially narrow original claim 5 before the amendment resulting in patented claim 1.
“a plurality of radially outermost surfaces”
“a plurality of fins”
New claim 40 is broader than patented claim 1; the new limitation of “a plurality of radially outermost surface” does not materially narrow original claim 5 before the amendment resulting in patented claim 1 since this limitation is well known in the prior art. See 35 USC 102 and 103 rejections below.
Limitation eliminated
“with respect to each other so as to define valleys”
Entire recapture of surrendered subject matter.
Limitation eliminated
“said fins adapted to engage said medullary canal in a removably stable fashion”
Entire recapture of surrendered subject matter.
Limitation eliminated
“disposed along said stem”
Entire recapture of surrendered subject matter.
“said plurality of outlets is disposed in said plurality of fluid-flow spaces”
“between an outer surface of one of said plurality of adjacent fins in said valleys”
New claim 40 is broader than patented claim 1; the new limitation of “said plurality of outlets is disposed in said plurality of fluid-flow spaces” does not materially narrow original claim 5 before the amendment resulting in patented claim 1 since this limitation is well known in the prior art. See 35 USC 102 and 103 rejections below.
Limitation eliminated
“a channel extending between said inlet and said plurality of outlets”
Entire recapture of surrendered subject matter.
Therefore, step 3 of the three-step test is met for claims 8-10, 14-16, 18-19, 26-35, 38-40, 42, 46-48, 50-51, 58-65 and 68-70.
The omission of “An antibiotic delivery system,” “femoral,” “femur,” “with respect to each other,” “said fins adapted to engage said medullary canal in a removably stable fashion,” and “disposed along the stem” from new claim 8 and “An antibiotic delivery system,” “femoral,” “femur,” “with respect to each other so as to define valleys,” “a plurality of fins,” “said fins adapted to engage said medullary canal in a removably stable fashion,” “disposed along said stem,” “between an outer surface of one of said plurality of adjacent fins in said valleys,” and “a channel extending between said inlet and said plurality of outlets” from new claim 40 invokes impermissible recapture of surrendered subject matter as detailed above by the three step test. Therefore, claims 8-10, 14-16, 18-19, 26-35, 38-40, 42, 46-48, 50-51, 58-65 and 68-70 are rejected under 35 U.S.C. 251 as indicated above.
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 claim limitations of
“a second channel within said head” of claims 26 and 58; and
“said second channel is in fluid communication with said first inlet” of claims 27 and 59
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.173 are required in reply to the Office action.
According to 37 CFR 1.173 (b)(3),
Drawings. One or more patent drawings shall be amended in the following manner: Any changes to a patent drawing must be submitted as a replacement sheet of drawings which shall be an attachment to the amendment document. Any replacement sheet of drawings must be in compliance with § 1.84 and shall include all of the figures appearing on the original version of the sheet, even if only one figure is amended. Amended figures must be identified as "Amended," and any added figure must be identified as "New." In the event that a figure is canceled, the figure must be surrounded by brackets and identified as "Canceled." All changes to the drawing(s) shall be explained, in detail, beginning on a separate sheet accompanying the papers including the amendment to the drawings.
As per MPEP 1413,
The provisions of 37 CFR 1.173(b)(3) govern the manner of making amendments (changes) to the drawings in a reissue application. The following guidance is provided as to the procedure for amending drawings:
(A) Amending the original or printed patent drawing sheets by physically changing or altering them is not permitted.
(B) Where a change to the drawings is desired, applicant must submit a replacement sheet for each sheet of drawings containing a Figure to be revised. Any replacement sheet must comply with 37 CFR 1.84 and include all of the figures appearing on the original version of the sheet, even if only one figure is being amended. Each figure that is amended must be identified by placing the word "Amended" at the bottom of that figure. Any added figure must be identified as "New." In the event that a figure is canceled, the figure must be identified as "Canceled" and also surrounded by brackets. All changes to the figure(s) must be explained, in detail, beginning on a separate sheet which accompanies the papers including the amendment to the drawings.
(C) If desired, applicant may include a marked-up copy of any amended drawing figure, including annotations indicating the changes made. Such a marked-up copy must be clearly labeled as "Annotated Marked-up Drawings" , and it must be presented in the amendment or remarks section that explains the change to the drawings.
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 8, 26, 40 and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 29 of U.S. Patent No. RE48,119 (“the ‘119 reissue patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because independent claims 8 and 40 of the instant reissue application are broader than independent claims 8 and 29 of the ‘119 reissue patent. The instant claims do not recite the limitations of the “a fluid removal element” of claim 8 or “a head” or “a fluid removal element” of claim 29 of the ‘119 reissue patent.
Claims 8, 26, 40 and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 28 and 38 of U.S. Patent No. RE46,669 (“the ‘669 reissue patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because independent claims 8 and 40 of the instant reissue application are broader than independent claims 8, 28 and 38 of the ‘669 reissue patent. The instant claims do not recite the limitations of the “a source of a fluid” of claim 8 or “a head” or “neck” of claim 38 of the ‘119 reissue patent.
Claims 8 and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. RE46283 (“the ‘283 reissue patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because independent claims 8 and 40 of the instant reissue application are broader than independent claim 18 of the ‘283 reissue patent. The instant claims do not recite the limitations of the “a source of a fluid” and “a second intramedullary implant” of claim 18 of the ‘283 reissue patent.
Claims 8 and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,433,965 (“the ‘965 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because independent claims 8 and 40 of the instant reissue application are broader than independent claim 1 of the ‘965 reissue patent. The instant claims do not recite the limitations of the “a femoral head” and “a femoral stem” of claim 1 of the ‘965 patent.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18-19, 38, 50-51 and 68 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 18-19, 38, 50-51 and 68 are directed to “[t]he wound may be covered with a polyurethane continuously connected porous sponge (for example, Granufoam manufactured by KCI).” However, the specification does not disclose that the porous sponge and source of negative pressure is part of the device of the ‘322 patent invention. Rather, the porous sponge and source of negative pressure is disclosed as being used in the overall method of using the device and treating the wound. Therefore, this claimed configuration is not supported by the figures and disclosure of the original ‘322 patent.
Claims 27 and 59 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 27 and 59 each recite “wherein said second channel is in fluid communication with said first inlet, such that when said first intramedullary stem is installed in said first medullary canal and said head is installed in said socket, infusion of a first fluid through said first inlet results in said first fluid infusing … via said second plurality of outlets into said socket.” However, this configuration is not shown in Figs. 13-14 or in the disclosure of the embodiment of Figs. 13-14. Rather, col. 10, ll. 22-25 states, “In the embodiment illustrated in FIGS. 14-15, the body 526 includes an inlet 520 and the femoral bead includes a separate inlet 521. Both inlets 520, 521 are in fluid communication with the source of fluid-borne antibiotic 116.” Therefore, the second channel (channel communicating with inlet 521) is not in fluid communication with the first inlet resulting in fluid infusing via the second plurality of outlets into the socket. This claimed configuration is not supported by the figures and disclosure of the original ‘322 patent.
Claims 40, 42, 46-48, 50-51, 58-65 and 68-70 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for “fins”, does not reasonably provide enablement for the full scope of “a plurality of radially outermost surfaces.”
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the full extent of the invention commensurate in scope with these claims. Below are the Wands factors used to assess whether necessary experimentation required is unreasonable or undue.
(A) The breadth of the claims are large. The structural element of “a plurality of outermost surfaces” is only structurally disclosed as fins in the ‘322 patent drawings and specification;
(B) The nature of the invention is in the field of medical joint implants that treat diseased tissue; furthermore, the nature of the invention is in the field of providing stability to devices implanted into the body.
(C) The state of the prior art at the time of the invention is directed to medical implants in general and structures specifically for use in providing stability to the implant. Structures for providing stability to implanted material are not only contained within the medical implant field. The state of the prior art directed to structures providing stability to implanted devices and material is extensive across all types of devices that are implanted within the body.
(D) The level of one of ordinary skill includes a medical doctor to include an orthopedist or biomedical engineer;
(E) The level of predictability in the art is low in that many different structures and configurations exist for providing stability to medically implanted structures in the body to include: vascular implants, cosmetic implants, bone and joint implants; access and egress ports and others;
(F) The amount of direction provided by the inventor is singular to fins;
(G) The existence of working examples is only directed to fins; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure is high considering only fins are shown in the figures and discussed in the specification. Furthermore, many devices implanted into the human body include structures for providing stability such as graft material, porous material, ridges, screws, pins, threads, grooves, recesses, surface etching, terracing, hooks, and barbs which is an incomplete list. All of these structures could be construed as being examples of or creating “a plurality of radially outermost surfaces.”
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s