Notice of Pre-AIA or AIA Status
The ‘575 patent contains new disclosure and claims that only entitles Applicant to a filing date after March 16, 2013, and is therefore being examined under the first inventor to file provisions of the AIA .
Note for example the cannulated screw in claim 33 which is not disclosed in either Provisional application that Applicant claims priority to.
Reissue Applications
For reissue applications filed before September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the law and rules in effect on September 15, 2012. Where specifically designated, these are “pre-AIA ” provisions.
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
As explained above, the present reissue application will be examined under the first inventor to file provisions of the AIA .
Litigation
Since the litigation related to this reissue application is terminated and final, action in this reissue application will NOT be stayed. Due to the related litigation status of this reissue application, EXTENSIONS OF TIME UNDER THE PROVISIONS OF 37 CFR 1.136(a) WILL NOT BE PERMITTED. The litigation PGR2021-00050 resulted in patent claims 1-9 being found unpatentable and have been canceled.
Continuing Obligations
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 Patent No. 10,709,575 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
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.
Claim Interpretation
The examiner provides the following definitions of some claim terms consistent with the PTAB decision in PGR2021-00050:
“Keyed distal end”- “the distal end is sized and shaped to fit at least partially within a distal cavity and is sized and shaped to engage corresponding surfaces on the upper and lower portions.”
“Unobstructed”- “there are no features lying in the path and blocking the window.” The examiner adds that it is clear that the “window” referred to in the claims is actually comprised of the three windows of the upper portion, lower portion and elongate expander where the three windows are aligned and overlap each other. That is a single window and in order for it to be “unobstructed” absolutely nothing can intrude into that window.
Specification
The disclosure is objected to because of the following informalities:
In the Spec Amendment of 10-14-2025, the amendment to the cover page is unnecessary and should be deleted. This section of the printed patent is generated by the data in the Application Data Sheet. In the amendment to col. 2 line 39, there is no “In” to begin this paragraph in the original patent and therefore should be either removed or underlined. In the amendment to col. 3 line 13, the removal of “partially” is NEW MATTER and must be deleted. In the amendment to col. 4 line 51, line 5 has a closing bracket with no apparent respective opening bracket. In the amendment to col. 4 line 66- line 3 “the” should not be underlined as it is original patent text.
Claim Rejections - 35 USC § 251 - 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, and
(C) the newly claimed invention is clearly and unequivocally disclosed in the specification as a separate invention with the claimed combination of features.
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, in the instant reissue application the disclosure does not support the limitations of:
in a fully expanded position the windows (or at least a portion of the windows) in each of the upper portion, the lower portion, and the elongate expander are open and unobstructed (or just unobstructed) with respect to one another when viewed from a bottom view”, as found in each independent claim; and
in claim 41 the distal end of the elongate expander, the distal end of the lower portion of the cage body, and the distal end of the upper portion of the cage body to extend distally to approximately a same plane; and
in claim 45, the elongate expander has top and bottom flat portions which are parallel to each other, and in the fully expanded position of the cage body the flat section of the upper portion of the cage body and the top flat portion of the elongate expander contact each other along a first plane, and the flat section of the lower portion of the expander and the bottom flat portion of the expander contact each other along a second plane;
in claim 48, wherein the 1st and 2nd planes are parallel when the cage body is in the expanded position; and
in claim 56, the flat portions of the expander are parallel, and the flat sections contact the flat portions when fully expanded; and
in claim 58, the two planes are parallel.
The original disclosure does not clearly and unequivocally disclose the newly claimed inventions as separate inventions. Therefore, claims 1-62 do not satisfy the “original patent” requirement.
Claims 1-62 are therefore rejected under 35 USC 251 for not claiming subject matter directed to the invention disclosed in the original patent.
Reissue New Matter
Claims 1-62 are rejected under 35 U.S.C. 251 as being based upon new matter added to the patent for which reissue is sought.
The following amendments to the specification and claims contain new matter:
In the amendment to the specification of 10-14-2025, in col. 3 line 13, the removal of “partially” is NEW MATTER as it has broadened the disclosure; and
In every independent claim, in a fully expanded position the windows (or at least a portion of the windows) in each of the upper portion, the lower portion, and the elongate expander are open and unobstructed (or just unobstructed) with respect to one another when viewed from a bottom view”; and
in claim 41 “the distal end of the elongate expander, the distal end of the lower portion of the cage body, and the distal end of the upper portion of the cage body to extend distally to approximately a same plane; and
in claim 45, the elongate expander has top and bottom flat portions which are parallel to each other, and in the fully expanded position of the cage body the flat section of the upper portion of the cage body and the top flat portion of the elongate expander contact each other along a first plane, and the flat section of the lower portion of the expander and the bottom flat portion of the expander contact each other along a second plane;
in claim 48, wherein the 1st and 2nd planes are parallel when the cage body is in the expanded position; and
in claim 56, the flat portions of the expander are parallel, and the flat sections contact the flat portions when fully expanded; and
in claim 58, the two planes are parallel.
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 1-62 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.
The specification, including the abstract and the claims, fails to provide an adequate written description of the invention as is now claimed; more specifically, the written description of the invention fails to specifically provide support for: In the amendment to the specification of 10-14-2025, in col. 3 line 13, the removal of “partially” is NEW MATTER; and
In every independent claim, in a fully expanded position the windows (or at least a portion of the windows) in each of the upper portion, the lower portion, and the elongate expander are open and unobstructed (or just unobstructed) with respect to one another when viewed from a bottom view”; and
in claim 41 “the distal end of the elongate expander, the distal end of the lower portion of the cage body, and the distal end of the upper portion of the cage body to extend distally to approximately a same plane; and
in claim 45, the elongate expander has top and bottom flat portions which are parallel to each other, and in the fully expanded position of the cage body the flat section of the upper portion of the cage body and the top flat portion of the elongate expander contact each other along a first plane, and the flat section of the lower portion of the expander and the bottom flat portion of the expander contact each other along a second plane;
in claim 48, wherein the 1st and 2nd planes are parallel when the cage body is in the expanded position; and
in claim 56, the flat portions of the expander are parallel, and the flat sections contact the flat portions when fully expanded; and
in claim 58, the two planes are parallel.
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 30 and 41-44 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.
With respect to (WRT) claim 30, there is no clear antecedent basis in line three for “the distal end” as there are three distal ends previously claimed.
WRT claim 41, in line 17 there is no clear antecedent basis in line three for “the distal end” as there are three distal ends previously claimed. In line 36, the use of the term “noticeably” is vague and indefinite as it is unclear what degree of extension would or would not meet this limitation.
Declaration of Hassan A. Serhan, PhD
The examiner disagrees with a couple assertions made by Dr. Serhan concerning the FIG. 67 embodiment of Weiman. The use of lengths in the annotated FIG. 67 shown on page 15 of the Declaration, e.g. Lthread and Lwindow , do not naturally follow from Weiman’s disclosure. The Figures are not disclosed as being drawn to scale and one cannot simply make physical measurements of certain components of a Figure from a patent and assume or arrive at a constructed view of what the device would look like in the fully expanded configuration. Therefore, it can’t be assumed that Weiman’s screw would obstruct the window formed by the openings in the upper and lower portions of the cage and the elongated expander in the fully expanded configuration. Weiman teaches the reason for providing the expander with a window 462 shown in FIG. 67 is “window 462 may be sized to receive bone graft or similar bone growth inducing material and allow bone graft or similar bone growth inducing material to be packed into the device 10. In some embodiments, the window 462 may align with through openings 464a, 464b in the first endplate 14 and second endplate 16, respectively”. Furthermore, the comments made on page 17 about the problems associated with shortening the length of Weiman’s screw are opinions unsupported by objective data or experimental evidence.
Response to Arguments
The examiner disagrees that the Figures provide support for all of the new amendments to the specification and claims. For example, Applicant argues that FIG. 2B shows the pivot pin at the bottom of the slot and therefore illustrates the cage in the fully expanded position. However, a close inspection of FIG. 2B does not show the pin in contact with the bottom of the slot as there is still a portion of the slot below the pin. FIG. 1B, 6B, 14, 18 and 19 all illustrate this. FIG. 18 actually is described as being in a “partially” expanded position. It is also unclear that FIG. 5B shows the cage in a “fully” expanded position. It is possible that when fully expanded the ‘575 patent device could also have its actuation screw creep into part of the windows thus obstructing the aligned windows. In fact, in PGR 2021-00050 the PTAB found that Figure 15 of the ‘575 patent shows that the actuation screw does in fact extend past the distal end of 1078 of the expander. Therefore, it would appear that when fully expanded the ‘575 patent device would have an obstructed window. No Figure clearly shows what the windows look like from the bottom view when in a “fully” expanded position. Therefore, the unobstructed window when the device is “fully” expanded limitation in each independent claim constitutes new matter and is unsupported by the original patent disclosure. Applicant states that FIG. 4B shows the distal end of the expander extends less distally than the lower portion of the cage body, and then two pages later states FIG. 4B also shows the distal ends of the upper portion, lower portion and the expander extend distally to approximately the same plane. The examiner contends that these two statements contradict each other, especially given the annotated figures provided. Fig. 18 also fails to show the cage in the fully expanded position.
The claim limitations of two planes or two structures being parallel don’t find clear support in the figures. The figures are not drawn with sufficient clarity and precision to support the claim limitations. Stating two surfaces are parallel requires two surfaces to continuously have the same distance between them, and the drawing Figures fail to clearly establish that this is the case, especially since no qualifying language such as substantially, essentially, or approximately has been used in conjunction with parallel or same plane.
Conclusion
Claims 1-62 are rejected.
THIS ACTION IS MADE FINAL.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eileen Lillis who can be reached at 571-272-6928.
Any general questions regarding this communication can be directed to the Central Reexamination Unit at 571-272-7705.
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All correspondence relating to this reissue application should be directed:
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By Mail to: Commissioner for Patents
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Signed: /GLENN K DAWSON/
Reexamination Specialist, Art Unit 3993
Conferees: /WILLIAM E DONDERO/ Reexamination Specialist, Art Unit 3993
/EILEEN D LILLIS/ SPRS, Art Unit 3993