DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 01/30/2026 have been fully considered but they are not persuasive.
Applicant argues: Griesbach does not teach joint distraction device for use in arthroscopy surgery having the claimed configuration.
Response: The office is of the position that it has been held that in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. In In re Schreiber, 128 F.3d 1473, 44 USPQ2d 1429 (Fed. Cir. 1997), the court affirmed a finding that a prior patent to a conical spout used primarily to dispense oil from an oil can inherently performed the functions recited in applicant’s claim to a conical container top for dispensing popped popcorn. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Moreover, it has been held that "[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)." {MPEP 2114 (II)}.
In this case, the office respectfully asserts that Griesbach discloses a device having a substantially identical structure to that claimed, detailed in the office action, and therefore inherently capable of performing the claimed functions, i.e. supporting a limb.
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 removable cover layer of claim 29 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 1.121(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 § 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 21 and 23 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.
In claim 21, the recitation of “the inflatable member and the pouch are formed separately” is found to have no support in the original disclosure. Applicant may provide explicit support for such limitation of cancel the claim to overcome this rejection.
In claim 23, the recitation of “wherein the inflatable member and the pouch are positioned on opposing sides of the opening.” Is found to have no support in the original disclosure, wherein Fig.1A shows the pouch to extend around the opening 104, supported by ¶23, which at least in part states that the pouch may have circular shape. Applicant may provide explicit support for such limitation of cancel the claim to overcome this rejection.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1 – 4, 6 – 7, 11 and 22 – 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Griesbach, III (US Pub. 2005/0126577 A1).
Claim 1, Griesbach discloses a joint distraction device for use in an arthroscopy surgery [abstract, Figs. 1 – 27], comprising:
a drape [10] configured for covering at least a portion of a patient during surgery, the drape having a top surface and a bottom surface [surfaces 16 and 18] and is configured to be disposed above the patient when in use during surgery, wherein the drape comprises an opening [22] configured to accept a limb, and an inflatable member [at least a portion of 20 / 28] configured to support the limb [i.e. Figs. 25 – 26], wherein the inflatable member is directly attached to the top surface of the drape and positioned adjacent to the opening [i.e. Fig. 27, ¶68, directly attached by securing system 56], and is inflated by a fluid from a deflated state to an inflated state [¶68 - ¶69], and a pouch attached to the top surface of the drape configured to collect or retain fluid from a surgical site [¶68 - ¶70, at least a portion of pouch 36 attached by securing system 56, Fig.27].
Griesbach discloses the limitations of claim 1, as above, and further, Griesbach discloses:
Claim 2, wherein the inflatable member is fluidly connected to a pump through an inlet port and is configured to allow fluid in to inflate the inflatable member [¶51, the inflatable member connected to pump 40 through port 42].
Claim 3, wherein the pump is a manual pump [¶51, air pump is hand operated].
Claim 4, wherein the pump is an electric pump [¶51, air pump is power operated].
Claim 6, wherein the pouch is positioned on the top surface of the drape [Figs. 25 - 27].
Claim 7, wherein the pouch comprises a drainage port configured to allow drainage of any fluids collected during the surgery [Figs. 25 – 27, port 60, ¶69].
Claim 11, wherein the device is disposable [¶69].
Claim 22, wherein the inflatable member and the pouch are positioned in different regions on the top surface of the drape [Figs. 25 – 27, wherein at least a portion of 20 and at least a portion of 36 are position in different positions on the top surface of the drape 10].
Claim 23, wherein the inflatable member and the pouch are positioned on opposing sides of the opening [Figs. 25 – 27, wherein at least a portion 20 is positioned on one side of the opening 22, and at least a portion of pouch 36 is positioned on opposing side of the opening, ¶68, wherein the pouch is provided around opening 58 which is aligned with 22].
Claim 24, wherein the pouch at least partially surrounds the opening of the drape and extends to one or more positions near the inflatable member [Figs. 25 – 27, ¶68].
Claim 25, wherein the inflatable member comprises one or more chambers [Figs. 25 – 27, ¶71, one or multiple expandable members 20, wherein in combination they define the expandable member 20, each defining chamber, or ¶54, wherein expandable member can have any number of chambers].
Claim 26, wherein the one or more chambers are configured to be separately inflated to one or more heights [¶65].
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griesbach, III (US Pub. 2005/0126577 A1) in view of Bonadio (US Pat. 5803921).
Claim 8, Griesbach discloses the limitations of claim 1, as above.
Griesbach does not disclose wherein the device further comprises a pressure regulator.
Bonadio teaches an analogous device [abstract, Figs. 1 – 31] comprising a pressure regulator [col.7/line 62 – col.8/line 8].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings Griesbach and Bonadio, and construct the inlet portion of the device of Griesbach to have pressure regulating valve in view of Bonadio. One would have been motivated to do so in order to allow the user control stabilizing the pressure flow into the inflatable member from the external pump.
Claim(s) 9 – 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griesbach, III (US Pub. 2005/0126577 A1) in view of Kazala, Jr. et al. (US Pub. 2009/0299340 A1).
Griesbach discloses the limitations of claim 1, as above.
Griesbach does not explicitly disclose wherein the inflatable member is inflated with a liquid medium selected from the group consisting of water, saline, and combinations thereof; or wherein the inflatable member is inflated with a gaseous medium.
Kazala teaches an analogous device [abstract, Fig. 1 – 7] comprising the use of liquid medium, i.e. saline, or gaseous medium for inflating an inflatable member [¶59].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Griesbach and Kazala, and modify the device of Griesbach to use gaseous medium or liquid medium in view of Kazala for inflating the inflatable member. One would have been motivated to do so in order to allow the user to use alternative biocompatible inflating mediums for inflating the inflatable member.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griesbach, III (US Pub. 2005/0126577 A1).
Claim 21, Griesbach discloses the limitations of claim 1, as above, except for explicitly disclosing wherein the inflatable member and the pouch are formed separately.
One having ordinary skill in the art before the effective filing date of the current application would have found it obvious to form the pouch and the inflatable member separately to provide the user with a wide variety of configurations, i.e. picking and attaching an inflatable member having a desired size and pouch having a desired size together for the intended use, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
Claim(s) 27 – 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griesbach, III (US Pub. 2005/0126577 A1) in view of Cadwalader et al. (US Pub. 2011/0095209 A1).
Griesbach discloses the limitations of claim 1, as above, except for disclosing (claim 27) wherein the inflatable member is textured to prevent slippage when supporting the limb; (claim 28) wherein the inflatable member comprises a coating or covering to prevent slippage when supporting the limb; (claim 29) a removable cover layer at least partially covering at least one of the drape, the inflatable member, and the pouch.
Cadwalader teaches an analogous device [abstract, Figs. 2 – 7] comprising a removable cover layer defining textured layer to prevent slippage [60, ¶48 - ¶52 and ¶58 - ¶59].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Griesbach and Cadwalader, and construct the device of Griesbach having a cover in view of Cadwalader to cover portions of the device that comes in contact with the patient. One would have been motivated to do so in order to prevent slippage or movement relative to the patient when in use [Cadwalader, ¶58].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL S. HANNA whose telephone number is (571)270-3248. The examiner can normally be reached 8-5 M-F.
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, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL S HANNA/Primary Examiner, Art Unit 3775