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 Amendment
This Office Action is responsive to the amendment filed on 12 February 2026. As directed by the amendment: claims 1, 3, 4, 8, and 9 have been amended, claims 6, 10-20, and 23 are cancelled, claims 21, 22, and 30-32 are withdrawn, and claims 33 and 34 are newly added. Claims 1-5, 7-9, 21, 22, and 24-34 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the claim objections listed in the previous action, which are correspondingly withdrawn.
The amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 112(b), which are correspondingly withdrawn. However, the current claim amendments have necessitated further rejections under 35 U.S.C. 112(b) as presented below.
Response to Arguments
As to the rejections under 35 U.S.C. 102(a)(1)/(2) as anticipated by McMinn (US 9,017,416), Applicant’s arguments have been fully considered but they are not persuasive. Applicant contends that McMinn describes the polymer liner 24 as a permanent component of the implant assembly that is mechanically attached to the metal shell 22 to form a composite one-piece cup. Applicant contends that McMinn intends the liner 24 to remain permanently with the metal shell 22 throughout implantation and the lifetime of the implant. Examiner respectfully submits that the claimed limitation that the releasable cover is releasable from the medical implant is interpreted as language of intended use. McMinn’s cover is fully capable of being releasable from a medical implant because it is mechanically attached, by, for example, a recess in the implant into which the cover extends (col. 12 / lines 52-54). Such a mechanical means of attachment is fully capable of being releasable. The lifetime of the implant is not infinite, and an implant could be removed during revision surgery and disassembled for disposal, or the cover may be removed from the implant if after assembly of the device the surgeon finds that the fit is not ideal or that a thicker or different dimensioned cover is required for best fit to the patient’s anatomy.
Applicant contends that polymer liner 24 is not releasable from acetabular cup prosthesis 70. Applicant points to McMinn’s disclosure of compression molding polymer layers on the metal shells of acetabular cups, which Applicant contends is not releasable. Examiner respectfully submits that McMinn also discloses that mechanical means can be used to attach the polymer liner 24 to the outer cup, such as a bore or recess into which the polymer liner extends (McMinn col. 12 / lines 52-54). Such a male/female interaction can be releasable, e.g. by popping the polymer out of the recesses. Even if the undercuts and polymer nodules pointed out by Applicant were used to secure the polymer liner to the cup, even this type of connection is fully capable of being releasable. A revision surgery could remove the entire liner/cup combination, with the liner removed from the cup for separate disposal of different materials.
Applicant contends that the impactor cap 72 is a separate surgical instrument component rather than part of the implant assembly itself, and that the impactor cap 72 is removed from the cup before implantation is complete, while the liner 24 remains permanently attached to the metal shell 22 as an integral part of the implanted device. Examiner respectfully submits that the impactor cap 72 is part of the assembly as disclosed by McMinn and shown in FIG. 6A for example. Even if the impactor cap 72 is removed from the cup, this does not preclude the removal of the liner 24 at another point, for revision surgery or for various situations as discussed above.
Applicant contends that the liner 24 remains with the implant after surgery during the entire functional life of the implant. Examiner respectfully submits that the lifetime of the implant is not infinite, and an implant could be removed during revision surgery and disassembled for disposal, or the cover may be removed from the implant if after assembly of the device the surgeon finds that the fit is not ideal or that a thicker or different dimensioned cover is required for best fit to the patient’s anatomy. Applicant contends that impactor cap 72 is releasable but does not form a seal with the implant as claimed. Examiner respectfully submits that the impactor cap is not relied upon to teach the seal.
Applicant contends that the loops in McMinn are attachment features for an introducer tool and are intended to be cut off and discarded after the implant has been positioned, and that McMinn provides no teaching or suggestion that the loops would be manipulated to disrupt any seal or release the polymer liner from the shell. Examiner respectfully submits that the claimed limitation that the releasable cover is releasable from the medical implant by manipulating the tabs is interpreted as language of intended use.
Manipulating one or more of the tabs is fully capable of disrupting a seal between the cover and the implant at least at the portion of the seal where the tabs are connected to the seal, since the tabs can be manipulated or pulled which is fully capable of deforming or disrupting the polymeric seal if enough force is applied, e.g. pulling the tab proximally can deform at least an adjacent part of the seal to move along with the tab. This manipulating is fully capable of releasing the cover from the implant, for example by pulling at least the adjacent part of the seal out of the implant to be grabbed for fully releasing the cover from the implant. This manipulating is fully capable of disrupting a hydraulic seal between the releasable cover and the medical implant, when such a seal is formed, since the seal itself is fully capable of being deformed/disrupted and therefore any seal including a hydraulic seal that is made by the seal would also be disrupted; since a hydraulic seal is commonly understood to mean a seal that prevents leakage of fluid, and McMinn discloses that the cover/seal and the implant are flushly mechanically mated together, then the seal formed between the cover and the implant is fully capable of being a hydraulic seal that does not allow fluid therethrough and therefore prevents fluid leakage. Because the loops are attached strongly enough to the liner that they can hold the device onto an introducer tool and have to be cut off (and not broken off by hand), and because the liner is polymer, the loops are fully capable of manipulating at least an adjacent part of the seal/liner which correspondingly would disrupt a seal formed by the seal/liner. As described below, McMinn discloses that the cover/seal and the implant are flushly mechanically mated together, so that a seal formed between the cover and the implant is fully capable of being a hydraulic seal that does not allow fluid therethrough and therefore prevents fluid leakage. Disruption of any part of the seal/liner would correspondingly disrupt the hydraulic seal.
Examiner notes that the claimed limitation that the releasable cover is releasable from the medical implant by manipulating the tabs is interpreted as language of intended use. Since the claims are apparatus claims and not method claims, the device need be capable of such intended use, which it is as described above.
Applicant contends that McMinn does not disclose tabs that are part of a seal component extend through slots formed in a body portion, with both the seal and the body portion forming parts of a unified releasable cover. Examiner notes that the term unified is not claimed, and respectfully submits that the cap and liner disclosed in McMinn are unified at least because they are united by proximity and frictional engagement with each other (McMinn FIG. 6A).
Examiner submits that McMinn is fully capable of the release mechanism, as described above.
As to claim 9, Applicant contends that McMinn’s liner 24 is not releasably fixable to the inner surface of the implant but is rather permanently mechanically attached. Examiner respectfully submits, as above, that permanent is relative, as is the lifetime of an implant.
As to dependent claim 2, the limitation that the material can be manipulated to deform the seal is interpreted as language of intended use. The tab can be manipulated or pulled which is fully capable of deforming the seal if enough force is applied.
As to dependent claim 24, Applicant contends that McMinn’s liner 24 (the seal) is not removably attachable to the impactor cap 72 (the body portion). Examiner submits that the liner is at least frictionally attachable to the impactor cap by frictional abutment and removable therefrom (col. 33 / lines 26-28).
As to dependent claim 25, Applicant contends that McMinn’s seal is not air- and/or watertight. Examiner submits that the region of fixed attachment is substantially air- and/or watertight because of the precise match between the abutting surfaces that is therefore substantially air- and/or watertight.
As to the rejections under 35 U.S.C. 103 as unpatentable over Slade (US 9,782,154), Applicant’s arguments have been fully considered but they are not persuasive. Applicant contends that a suction cup as in Slade does not create a hydraulic seal. Applicant defines a hydraulic seal as designed to contain and control pressurized liquid (typically oil) inside hydraulic cylinders or similar fluid power components, preventing leakage and maintaining system pressure. Examiner respectfully submits that a hydraulic seal is commonly understood to mean a seal that prevents leakage of fluid. By this definition, Slade meets the claimed limitation because the seal between the cover and the implant in Slade is fully capable of being a hydraulic seal that does not allow fluid therethrough because it is a suction seal and therefore prevents fluid leakage because fluid would not pass through the seal. The seal is fully capable of being a hydraulic seal upon displacement of fluid between the seal and the implant, since the seal and the implant in Slade are vacuum sealed together so that when a fluid is placed between them before complete seating of the seal, the fluid will be displaced when the seal and the implant mate together, therefore forming a hydraulic seal. Slade meets the broader definition of a hydraulic seal. A narrower definition of a hydraulic seal, as presented by Applicant in the arguments (page 14), is not supported by the specification as originally filed. The instant invention itself does not appear to contain and control pressurized liquid (typically oil) inside hydraulic cylinders or similar fluid power components, and therefore Slade meets the claimed limitation as much as the instant invention. Similarly, the claimed invention also discloses “suction” (claim 9), just as Slade does.
As to claim 9, Applicant contends that Slade requires the introducer for manipulating the suction cup and therefore could not be retainable to the medical implant by suction formed between the seal and the medical implant when pressed together by hand without influence from the introducer. Examiner respectfully submits that being pressed together by hand without influence from the introducer is interpreted as language of intended use. The seal and implant are fully capable of being pressed together by hand without influence from the introducer, since a user’s hand can squeeze the parts together, thereby displacing any fluid between them to form the seal.
As to claim 34, the features are disclosed by Slade as presented in the new rejection below.
Applicant contends that Slade discloses a surgical instrument that is held and manipulated by a surgeon during an implantation procedure, not a cover that is attached to an implant and left in place during surgical handling. Slade’s suction cup is an integral component of the instrument and permanently attached to actuation rod 20. Slade’s device does not contemplate separating the suction cup from the instrument or using the suction cup as a standalone cover that remains attached to an implant when the instrument is removed. Examiner respectfully submits that these features are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims do not require separating the suction cup from the instrument or using the suction cup as a standalone cover that remains attached to an implant when the instrument is removed. Examiner also submits that the suction cup in Slade is removable from the instrument, as seen in FIGS. 17-20, where the rod 20 slidingly receives a proximal lug on the suction cup, so that the suction cup is fully capable of separating from the instrument and being standalone.
Applicant contends that while Slade’s suction cup can be released from the implant surface by breaking the vacuum seal, the suction cup itself is not released from the instrument and is not left attached to the implant after the instrument is removed. As above, the features that the suction cup is released from the instrument and left attached to the implant are not claimed. The claimed feature that the seal/suction cup is releasable from the implant is met by Slade which discloses that the suction cup can be released from the implant surface.
Applicant contends that the claimed plurality of tabs and slots provides significant functional advantages that are not present in Slade’s single tab configuration, which provides only a single point of release. Examiner respectfully submits that the mere duplication of the essential working parts of a device involves only routine skill in the art. Providing a plurality of tabs would allow the seal to be peeled back from both sides at once, where the tabs are connected to the seal, by manipulating/pulling taut the tabs, thus facilitating easier and quicker breaking of the vacuum seal to release the implant, and an evenly distributed pull back on the seal to prevent damaging the seal itself. The plurality of tabs would also allow a surgeon to manually release the seal from either side depending on accessibility. It is well known in the art to provide duplicative or redundant features in the event of failure of one feature. For example, if one tab breaks, the provision of another tab would prevent the complete failure of the device.
Applicant contends that the claimed configuration wherein each of a plurality of slots is configured to allow a different tab of the plurality of tabs to pass therethrough represents a specific structural design that is not simply a duplication of Slade’s single slot. The configuration required each slot to be sized and positioned for a specific corresponding tab. Examiner respectfully submits that providing a plurality of tabs would require a corresponding plurality of slots to accommodate the plurality of tabs. Since Slade discloses that the slot receives the tab at a particular relative orientation of the parts, FIG. 18, and that the slot and tab are compatible in size and position, it would have been obvious to similarly position additional slots so that they receive corresponding additional tabs and that the additional slots and tabs are similarly compatibly sized and positioned. For example, a second tab/slot pair could be positioned directly on the other side of the device. It is not a significant redesign to provide a second tab/slot pair somewhere around the device.
Applicant contends that Slade’s vacuum retention mechanism is inherently dependent on the actuation rod and the handle assembly, whereas the pending claims contemplate a cover that can be attached to an implant and retained thereon through a seal that is disrupted by manipulating tabs. Applicant contends that the claims do not require that the seal be maintained by an actuation rod or other mechanical component. Examiner respectfully submits that the claims do not require that the seal not be maintained by an actuation rod or other mechanical component, and whether Slade’s device utilizes an actuation rod and handle assembly does not preclude Slade’s device reading on the claimed limitations. Slade discloses a cover that can be attached to an implant and retained thereon through a seal that is disrupted by manipulating tabs (col. 12 / lines 8-24).
Applicant contends that Slade’s device is directed to solving a different problem than the problem addressed by the claimed invention. Slade’s stated purpose is to provide an instrument for manipulating an implant. The claimed invention addresses the problem of providing a protective cover that can be temporarily attached to an implant to protect the bearing surface during handling, while allowing the cover to be easily released. Examiner respectfully submits that Slade’s device also serves as a protective cover since the body portion and the seal “cover” the bearing surface of the implant, and are temporarily attached and easily released due to the tabs that release the suction. Just as in the instant invention, Slade’s device can be attached to the implant without requiring special holding features on the implant itself, since the seal is a suction cup, and that can be released by manipulating tabs to disrupt the suction of the seal.
As to claim 2, Applicant contends that Slade’s pulling a release cord to peel back an edge of the suction cup to break the vacuum is different than manipulating tabs to deform a seal. Examiner does not see a material difference. The release cord in Slade is interpreted as a “tab” (projecting part) that is manipulated to peel back (deform) a seal.
As to claim 3, Applicant contends that Slade’s impaction plate 12 is not part of a releasable cover that remains attached to an implant. Examiner submits that Slade’s cover is in contact with the implant (FIG. 22) as required by the claim.
The remaining arguments as to other dependent claims amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. The claims are addressed in the following rejections.
As to claim 9, Applicant contends that Slade’s suction cup is an integral component of a handheld instrument and Slade’s suction cup is not a cover that is releasably fixable to an inner surface of an implant. Examiner submits that Slade’s suction cup is integral to the instrument in that it is required, but is not un-removable, as seen in FIGS. 17-20, where the rod 20 slidingly receives a proximal lug on the suction cup, so that the suction cup is fully capable of separating from a rest of the instrument. Slade’s device serves as a protective cover since the body portion and the seal “cover” the bearing surface of the implant, and are temporarily attached and easily released due to the tabs that release the suction.
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.
Claim 9 is rejected under 35 U.S.C. 112(a) 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.
As to claim 9, the limitation “pressed together by hand without influence from the introducer” is not supported by the specification as originally filed. Although the specification recites that the seal/cover and the implant can be pressed together separately and then fitted onto the introducer, the specification does not recite that they are pressed together by hand without influence from the introducer. The specification does not recite that the pressing is by hand, and that the introducer does not perform this first step, to be removed (for transport to the surgical suite, for example) and then refitted.
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.
Claim 33 is rejected under 35 U.S.C. 112(b) 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.
As to claim 33, the limitation “a cylindrical diameter” renders the claim indefinite because it is unclear how a diameter, which is a straight line, can be cylindrical. For examination purposes, the claim will be interpreted as the end region has a diameter.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 7-9, 24-29, and 33 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 9,017,416 to McMinn.
As to claim 1, McMinn discloses a releasable cover (72 and 24; covers the inside surface and top of the implant and is releasable because a mechanical means of attachment, such as a recess into which the cover extends, col. 12 / lines 52-54, can be detached) that is releasable from a medical implant (22) (col. 30 / lines 26-41), FIGS. 6A-6D, the releasable cover comprising a body portion (72) and a seal (24; where a seal is something that secures), FIG. 6A, the body portion comprising a distal end (89) (col. 32 / lines 19-24), FIG. 14C, and a proximal end (proximal facing surface), wherein the distal end includes a recessed region (proximal region of the distal end 89, which is radially recessed compared to flange 80) and an end region (distal region of the distal end 89) that projects further distal from the recessed region, wherein the proximal end comprising a region (center hole) adapted for connecting to an introducer (interpreted as language of intended use; fully capable of connecting to an introducer that fits within the center hole) and the seal comprising a plurality of tabs (portions of 74s that connect to/extend from 24, i.e. each loop comprises two tabs) extending away in a proximal direction from the body portion (col. 30 / lines 42-49), FIG. 6A, wherein the seal is attached (at least frictionally) to the distal end of the body portion (col. 32 / lines 19-24), wherein the proximal end of the body portion comprises a plurality of slots (82) (the slots extend through the proximal end/surface) each configured to allow a different tab of the plurality of tabs to pass therethrough, FIG. 6A, and wherein the releasable cover is releasable from the medical implant by manipulating one or more of the plurality of tabs on the seal in order to disrupt a hydraulic seal between the releasable cover and the medical implant (manipulating one or more of the tabs is fully capable of disrupting a seal between the cover and the implant at least at the portion of the seal where the tabs are connected to the seal, since the tabs can be manipulated or pulled which is fully capable of deforming or disrupting the polymeric seal if enough force is applied, e.g. pulling the tab proximally can deform at least an adjacent part of the seal to move along with the tab; this manipulating is fully capable of releasing the cover from the implant, for example by pulling at least the adjacent part of the seal out of the implant to be grabbed for fully releasing the cover from the implant; this manipulating is fully capable of disrupting a hydraulic seal between the releasable cover and the medical implant, when such a seal is formed, since the seal itself is fully capable of being deformed/disrupted and therefore any seal including a hydraulic seal that is made by the seal would also be disrupted; since a hydraulic seal is commonly understood to mean a seal that prevents leakage of fluid, and McMinn discloses that the cover/seal and the implant are flushly mechanically mated together, then the seal formed between the cover and the implant is fully capable of being a hydraulic seal that does not allow fluid therethrough and therefore prevents fluid leakage).
As to claim 2, McMinn discloses the releasable cover according to claim 1, wherein the seal and the plurality of tabs comprise a material (polymer, col. 30 / lines 35-37) that can be manipulated to deform the seal (interpreted as language of intended use; the tab can be manipulated or pulled which is fully capable of deforming the seal if enough force is applied, e.g. pulling the tab proximally can deform at least an adjacent part of the seal to move along with the tab; this manipulation and deformation can also occur before assembly with the implant).
As to claim 3, McMinn discloses the releasable cover according to claim 1, wherein the body portion comprises at least one raised portion (radially extending portions forming/extending around slots 82, where the radially extending portions are raised relative to the slots) between the proximal and distal ends (a thickness of the raised portion is between the proximal end/surface and the distal end) that is configured to assist in maintaining contact between the releasable cover (at 72) and the medical implant when in use (since the raised portions overlap the implant), FIG. 6A.
As to claim 4, McMinn discloses the releasable cover according to claim 3, wherein the at least one raised portion comprises two raised portions approximately equidistant from each other (two opposite raised portions are equidistant from each other around the body portion).
As to claim 7, McMinn discloses the releasable cover according to claim 1, wherein there is a raised portion adjacent each of the plurality of slots of the body portion (since the slots are formed by the raised portions), FIG. 6A.
As to claim 8, McMinn discloses the releasable cover according to claim 1, wherein the medical implant is a cup implant, FIG. 6A, and the releasable cover is profiled to fit within the cup implant.
As to claim 24, McMinn discloses the releasable cover according to claim 1, wherein the seal (24) is removably attachable to the body portion (72) (col. 33 / lines 26-28).
As to claim 25, McMinn discloses the releasable cover according to claim 1, wherein the seal is fixedly attached to the distal end (89) of the body portion at a region of fixed attachment (where bulbous surface of 89 precisely matches an inner surface of 24), and wherein said region of fixed attachment forms an air- and/or watertight, or a substantially air- and/or watertight, seal between the seal and the body portion (the region of fixed attachment is substantially air- and/or watertight because of the precise match between the abutting surfaces that is therefore substantially air- and/or watertight).
As to claim 26, McMinn discloses the releasable cover according to claim 1, wherein the body portion comprises a rim (exterior perimeter of 72), FIG. 6A.
As to claim 27, McMinn discloses the releasable cover according to claim 26, wherein the rim of the body portion is contoured to match a rim contour of the medical implant.
As to claim 28, McMinn discloses the releasable cover according to claim 1, wherein a rim (an upper rim) of the seal is contoured to match a contour of a rim of the body portion (exterior perimeter of 72) except for the plurality of tabs, FIG. 6A.
As to claim 29, McMinn discloses the releasable cover according to claim 1, wherein a rim (an upper rim) of the seal sits distally from a rim of the body portion (exterior perimeter of 72) except for the plurality of tabs, FIG. 6A.
As to claim 33, McMinn discloses the releasable cover according to claim 1, wherein the end region has a cylindrical diameter (the end region has a diameter which is the diameter of a cylindrical shape having the same diameter).
As to claim 9, McMinn discloses a system comprising: a medical implant (22); and a cover (72 and 24; covers the inside surface and top of the implant) releasably fixable to an inner surface of the medical implant (interpreted as language of intended use; fully capable of release at least during revision surgery), wherein the cover comprises a body portion (72) and a seal (24; where a seal is something that secures), FIG. 6A, wherein the body portion comprises a distal end (89) (col. 32 / lines 19-24), FIG. 14C, and a proximal end (proximal facing surface), wherein the proximal end comprises a region (center hole) adapted for connecting to an introducer (interpreted as language of intended use; fully capable of connecting to an introducer that fits within the center hole), and wherein the seal comprises a plurality of tabs (portions of 74s that connect to/extend from 24, i.e. each loop comprises two tabs) extending away in a proximal direction from the body portion (col. 30 / lines 42-49), FIG. 6A, wherein the seal is configured to form a hydraulic seal with an inner surface of the medical implant upon displacement of fluid between the seal and the inner surface (interpreted as language of intended use; the seal is fully capable of forming a hydraulic seal with an inner surface of the implant upon displacement of fluid between the seal and the inner surface, since the seal and the inner surface of the implant are flushly mated together so that when a fluid is placed between them before complete seating of the seal, the fluid will be displaced when the seal and the inner surface mate together, therefore forming a hydraulic seal), and wherein the cover is retainable to the medical implant by suction formed between the seal and the medical implant when pressed together by hand without influence from the introducer (interpreted as language of intended use; when the seal is seated into and mated with the inner surface of the implant by displacement of fluid – as described as fully capable of above – a hydraulic seal is formed, which forms suction between the seal and the medical implant; the seal and implant are fully capable of being pressed together by hand without influence from the introducer, since a user’s hand can squeeze the parts shown in FIG. 6D together, thereby displacing any fluid between them), wherein the seal is attached (at least frictionally) to the distal end of the body portion (col. 32 / lines 19-24), and wherein the proximal end of the body portion comprises a plurality of slots (82) (the slots extend through the proximal end/surface) each configured to allow a different tab of the plurality of tabs to pass therethrough, FIG. 6A; wherein the cover is releasable from the medical implant by manipulating one or more of the plurality of tabs on the seal in order to disrupt the hydraulic seal between the cover and the medical implant (manipulating one or more of the tabs is fully capable of disrupting the seal between the cover and the implant at least at the portion of the seal where the tabs are connected to the seal, since the tabs can be manipulated or pulled which is fully capable of deforming or disrupting the polymeric seal if enough force is applied, e.g. pulling the tab proximally can deform at least an adjacent part of the seal to move along with the tab; this manipulating is fully capable of releasing the cover from the implant, for example by pulling at least the adjacent part of the seal out of the implant to be grabbed for fully releasing the cover from the implant).
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.
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.
Claims 1-3, 5, 7-9, 24-29, 33, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 9,782,154 to Slade et al. (hereinafter, “Slade”).
As to claim 1, Slade discloses a releasable cover (12, 20, and 22) that is releasable from a medical implant (200), FIGS. 18, 21, 22, the releasable cover comprising a body portion (12 and 20) and a seal (22) (col. 10 / lines 47-50), the body portion comprising a distal end (at 20), FIG. 23, and a proximal end (including and proximal to 80 on 12), FIG. 23, wherein the distal end includes a recessed region (region of 20 surrounding recess 108) and an end region (111) that projects further distal from the recessed region (col. 9 / lines 34-59), FIG. 20, wherein the proximal end comprising a region adapted for connecting to an introducer (4), FIGS. 21 and 23, and the seal comprising a tab (104) extending away in a proximal direction from the body portion (the tab extends proximally away from at least raised portion/rim 80), FIG. 18, wherein the seal is attached to the distal end of the body portion (col. 9 / lines 34-42), FIG. 23, wherein the proximal end of the body portion comprises a slot (116) configured to allow the tab to pass therethrough (col. 10 / lines 16-17), and wherein the releasable cover is releasable from the medical implant by manipulating the tab on the seal in order to disrupt a hydraulic seal between the releasable cover and the medical implant (col. 12 / lines 8-24), FIG. 23 (interpreted as language of intended use; manipulating the tab on the seal disrupts the seal between the cover and the implant, and is fully capable of disrupting the seal when the seal is a hydraulic seal, which is commonly understood to mean a seal that prevents leakage of fluid, such that the seal between the cover and the implant in Slade is fully capable of being a hydraulic seal that does not allow fluid therethrough because it is a suction seal and therefore prevents fluid leakage; the seal is fully capable of being a hydraulic seal upon displacement of fluid between the seal and the implant, since the seal and the implant in Slade are vacuum sealed together so that when a fluid is placed between them before complete seating of the seal, the fluid will be displaced when the seal and the implant mate together, therefore forming a hydraulic seal).
As to claim 2, Slade discloses the releasable cover according to claim 1, wherein the seal and the tab comprise a material that can be manipulated to deform the seal (col. 12 / lines 8-24), FIG. 23.
As to claim 3, Slade discloses the releasable cover according to claim 1, wherein the body portion comprises at least one raised portion (82) between the proximal and distal ends, FIG. 23, that is configured to assist in maintaining contact between the releasable cover and the medical implant when in use, FIG. 21.
As to claim 5, Slade discloses the releasable cover according to claim 3, wherein the seal extends over the at least one raised portion (the tab of the seal extends over the raised portion), FIG. 18.
As to claim 7, Slade discloses the releasable cover according to claim 1, wherein there is a raised portion (80) adjacent the slot of the body portion, FIG. 18.
As to claim 8, Slade discloses the releasable cover according to claim 1, wherein the medical implant is a cup implant (200), and the releasable cover is profiled to fit within the cup implant (col. 10 / lines 29-33), FIG. 21.
As to claim 24, Slade discloses the releasable cover according to claim 1, wherein the seal is removably attachable to the body portion (col. 9 / lines 55-59).
As to claim 25, Slade discloses the releasable cover according to claim 1, wherein the seal is fixedly attached to the distal end (at 20) of the body portion at a region of fixed attachment (100/108), and wherein said region of fixed attachment forms an air- and/or watertight, or a substantially air- and/or watertight, seal between the seal and the body portion (at 20) (col. 9 / lines 40-59; the region of fixed attachment is substantially air- and/or watertight because the resiliency of the lug 100 creates an interference fit that is substantially air- and/or watertight).
As to claim 26, Slade discloses the releasable cover according to claim 1, wherein the body portion (at 12) comprises a rim (80).
As to claim 27, Slade discloses the releasable cover according to claim 26, wherein the rim of the body portion is contoured to match a rim contour of the medical implant, FIG. 21.
As to claim 28, Slade discloses the releasable cover according to claim 1, wherein a rim (88) of the seal (col. 9 / lines 37-38), FIG. 19, is contoured to match a contour of a rim (78) of the body portion (at 12) (col. 9 / lines 11-13) (the rim of the seal matches or corresponds to a contour of the rim of the body portion because it follows along the rim of the body portion while not overlapping) except for the tab, FIG. 22.
As to claim 29, Slade discloses the releasable cover according to claim 1, wherein a rim (88) of the seal sits distally from a rim (78) of the body portion, FIG. 22, except for the tab.
As to claim 33, Slade discloses the releasable cover according to claim 1, wherein the end region (111) has a cylindrical diameter (the end region has a diameter which is the diameter of a cylindrical shape having the same diameter; the end region is at least partially cylindrical and has the diameter of that cylinder).
Slade is silent as to a plurality of the tabs and a plurality of the slots, each of the plurality of slots configured to allow a different tab of the plurality of tabs to pass therethrough, and wherein the releasable cover is releasable from the medical implant by manipulating one or more of the plurality of tabs.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a plurality of tabs, such as one tab on each side of the seal, and a plurality of slots, such as one slot on each side of the body portion, with each slot configured to allow a different tab of the plurality of tabs to pass therethrough, since the mere duplication of the essential working parts of a device involves only routine skill in the art. Providing a plurality of tabs would allow the seal to be peeled back from both sides at once, where the tabs are connected to the seal, by manipulating/pulling taut the tabs, thus facilitating easier and quicker breaking of the vacuum seal to release the implant, and an evenly distributed pull back on the seal to prevent damaging the seal itself. The plurality of tabs would also allow a surgeon to manually release the seal from either side depending on accessibility. The body portion would be provided with a corresponding plurality of slots to accommodate the plurality of tabs. There would be a raised portion (80) adjacent each of the plurality of slots because each of the plurality of slots is cut into/through and defined by adjacent portions of the raised portion.
As to claim 9, Slade discloses a system comprising: a medical implant (200); and a cover (12, 20, and 22) releasably fixable to an inner surface of the medical implant, FIGS. 18, 21, 22, wherein the cover comprises a body portion (12 and 20) and a seal (22) (col. 10 / lines 47-50), wherein the body portion comprises a distal end (at 20), FIG. 23, and a proximal end (including and proximal to 80 on 12), FIG. 23, wherein the proximal end comprises a region adapted for connecting to an introducer (4), FIGS. 21 and 23, and wherein the seal comprises a tab (104) extending away in a proximal direction from the body portion (the tab extends proximally away from at least raised portion 80), FIG. 18, wherein the seal is configured to form a hydraulic seal with an inner surface of the medical implant upon displacement of fluid between the seal and the inner surface (interpreted as language of intended use; the seal in Slade is fully capable of being a hydraulic seal upon displacement of fluid between the seal and the inner surface of the implant, since the seal and the implant in Slade are vacuum sealed together, col. 12 / lines 8-24, so that when a fluid is placed between them before complete seating of the seal, the fluid will be displaced when the seal and the implant mate together, therefore forming a hydraulic seal), and wherein the cover is retainable to the medical implant by suction formed between the seal and the medical implant (col. 12 / lines 8-24) when pressed together by hand without influence from the introducer (interpreted as language of intended use; when the seal is seated into and mated with the inner surface of the implant by displacement of fluid – as described as fully capable of above – a hydraulic seal is formed, which forms suction between the seal and the medical implant; the seal and implant are fully capable of being pressed together by hand without influence from the introducer, since a user’s hand can squeeze the parts together, thereby displacing any fluid between them), wherein the seal is attached to the distal end of the body portion (col. 9 / lines 34-42), FIG. 23, and wherein the proximal end of the body portion comprises a slot (116) configured to allow the tab to pass therethrough (col. 10 / lines 16-17); wherein the cover is releasable from the medical implant by manipulating the tab on the seal in order to disrupt the hydraulic seal between the cover and the medical implant (col. 12 / lines 8-24), FIG. 23.
Slade is silent as to a plurality of the tabs and a plurality of the slots, each of the plurality of slots configured to allow a different tab of the plurality of tabs to pass therethrough; wherein the cover is releasable from the medical implant by manipulating one or more of the plurality of tabs.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a plurality of tabs, such as one tab on each side of the seal, and a plurality of slots, such as one slot on each side of the body portion, with each slot configured to allow a different tab of the plurality of tabs to pass therethrough, since the mere duplication of the essential working parts of a device involves only routine skill in the art. Providing a plurality of tabs would allow the seal to be peeled back from both sides at once, where the tabs are connected to the seal, by manipulating/pulling taut the tabs, thus facilitating easier and quicker breaking of the vacuum seal to release the implant, and an evenly distributed pull back on the seal to prevent damaging the seal itself. The plurality of tabs would also allow a surgeon to manually release the seal from either side depending on accessibility. The body portion would be provided with a corresponding plurality of slots to accommodate the plurality of tabs. There would be a raised portion (80) adjacent each of the plurality of slots because each of the plurality of slots is cut into/through and defined by adjacent portions of the raised portion.
As to claim 34, Slade discloses a releasable cover (2 and 22) that is releasable from a medical implant (200), FIGS. 3, 4, 18, 21, 22, the releasable cover comprising a body portion (2) (col. 5 / line 62 – col. 6 / line 23) and a seal (22) (col. 10 / lines 47-50), the body portion comprising a distal end (at the distal end of 20), FIG. 23, and a proximal end (remainder of 2), wherein the proximal end comprises a first recess (28), a boss (handle portion of 4 ; where a boss is commonly understood to mean a protuberant part - the boss 4 is proximally protuberant from a rest of the device) and a second recess (recess 26 in 4), FIG. 4, wherein the first recess surrounds the boss (col. 6 / lines 24-27), FIG. 3, and the second recess is formed in the boss, FIG. 4, wherein together the first recess, the boss and the second recess comprise a region (handle region) adapted for connecting to an introducer (interpreted as language of intended use; fully capable of connecting to an introducer such as a surgeon who introduces the cover to the implant and the implant to the patient), wherein the seal comprises a tab (104) extending away in a proximal direction from the body portion (the tab extends proximally away from at least raised portion 80), FIG. 18, wherein the seal is attached to the distal end of the body portion (col. 9 / lines 34-42), FIG. 23, wherein the proximal end of the body portion comprises a slot (116) configured to allow the tab to pass therethrough (col. 10 / lines 16-17), and wherein the releasable cover is releasable from the medical implant by manipulating the tab on the seal in order to disrupt a hydraulic seal between the releasable cover and the medical implant (the seal in Slade is fully capable of being a hydraulic seal upon displacement of fluid between the seal and the inner surface of the implant, since the seal and the implant in Slade are vacuum sealed together, col. 12 / lines 8-24, so that when a fluid is placed between them before complete seating of the seal, the fluid will be displaced when the seal and the implant mate together, therefore forming a hydraulic seal) (col. 12 / lines 8-24), FIG. 23.
Slade is silent as to a plurality of the tabs and a plurality of the slots, each of the plurality of slots configured to allow a different tab of the plurality of tabs to pass therethrough; wherein the cover is releasable from the medical implant by manipulating one or more of the plurality of tabs.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a plurality of tabs, such as one tab on each side of the seal, and a plurality of slots, such as one slot on each side of the body portion, with each slot configured to allow a different tab of the plurality of tabs to pass therethrough, since the mere duplication of the essential working parts of a device involves only routine skill in the art. Providing a plurality of tabs would allow the seal to be peeled back from both sides at once, where the tabs are connected to the seal, by manipulating/pulling taut the tabs, thus facilitating easier and quicker breaking of the vacuum seal to release the implant, and an evenly distributed pull back on the seal to prevent damaging the seal itself. The plurality of tabs would also allow a surgeon to manually release the seal from either side depending on accessibility. The body portion would be provided with a corresponding plurality of slots to accommodate the plurality of tabs. There would be a raised portion (80) adjacent each of the plurality of slots because each of the plurality of slots is cut into/through and defined by adjacent portions of the raised portion.
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 TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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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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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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