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 .
Claim Interpretation
The Office notes the 112 rejection with respect to configured has been removed by the Office. Applicant has stated the following for the record: “Claims 1-4, 6-7, 9, and 12-17 are rejected pursuant to 35 U.S.C. § 112(b) as being indefinite. With respect to claims 1 and 13, the Examiner asserts that "Applicant has selected language such as configured and Applicant has failed to make clear the state of the invention within the claims." Office Action, p. 3. The Examiner further asserts that "Applicant should replace the above language with language such as comprising that makes clear as to the state of the elements and their relative positioning with respect to one another." Id. Applicant respectfully disagrees. Use of the word "configured" in a claim is one example of functional language, where "a feature [is recited] 'by what it does rather than by what it is."' MPEP § 2173.05(g) (citing In re Swinehart, 439 F.2d 210, 212 (CCPA 1971)). "Functional language does not, in and of itself, render a claim improper." Id. Instead, "[a] functional limitation must be evaluated and considered, just like any other limitation of the claim, for what it fairly conveys to a person of ordinary skill in the pertinent art in the context in which it is used." Id. Here, the rejection of claims 1 and 13 depends entirely upon Applicant's use of the term "configured," despite "configured" being a common example of functional language. As the MPEP makes clear, the use of functional language must be evaluated like any other limitation, and it is improper to reject a claim simply for the use of said functional language. Replacement of configured with a word such as "comprising" as suggested by the Examiner only serves to remove the permissible functional language from the claim - it does not serve to render the claim any more definite. Further, despite the Examiner's requirement that the claim language should be amended to "make[] clear as to the state of the elements and their relative positioning with respect to one another," the functional language provided in the claim does provide information and clarity to a person having ordinary skill in the art as to the state of the elements and their relative positioning. Office Action, p. 3. For example, the claim 1 limitation "an inner tube configured to be disposed within the outer tube" instantly informs some structure of the claim by indicating that the inner tube must be sized as to be disposable within the outer tube. This is but one example of the information and clarity provided in the claims that is sought by the Examiner, and there are many more within the limitations. Therefore, because the reliance upon functional language is not enough to render a claim indefinite, claims 1 and 13 are definite for at least this reason.”
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 6, 7, 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Richart (20140042050) in view of Klopovic (2412275).
Richart discloses:
1. A surgical holding system (figs 1-8), comprising: an outer tube (4) having a sealed first outer end and an open second outer end (adjacent top and bottom), the outer tube having a removable outer cap configured to selectively seal the second outer end (3 capable of performing the above intended use); an inner tube configured to be disposed within the outer tube (adjacent 2 capable of performing the above intended use), the inner tube having a sealed first inner end configured to abut against the outer cap of the outer tube (portion adjacent 3 capable of performing the above intended use), the inner tube having an open second inner end and a removable inner cap configured to selectively seal the second inner end (adjacent 21 capable of performing the above intended use); a plurality of surgical implants [5; The Office notes that Applicant discloses that the implants can be either screws or nuts, such as in claim 14 and that the prior art also states “Said article can be, for example, a solid component, such as a surgical screw, or any other type of article, in particular any other type of implant. In addition, said article can be a liquid or a powder” paragraph 52; though not required, the Office merely notes that washers and nuts are common implants and it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the type of implant to that of a washer or nut in order to provide an element that functions for a desired procedure such as by providing the capability of fastening a screw in place;
The Office further notes that the prior art appears to disclose a singular implant contained therein; it is well within the skill of one of ordinary skill in the art to provide multiple implants as for example if the procedure that the device is being used for required multiple implants; further, having multiple implants available together will speed up and enhance the surgical procedure; though not required, the Office merely notes to expedite prosecution for Applicant that it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device (such as with multiple implants) because it has been held that the duplication of parts on the basis of its suitability for the intended use was an obvious extension of the prior teachings. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)];
with the exception of the following which is disclosed by Klopovic: a holder configured to be disposed within the inner tube and having a longitudinal axis, the holder being configured to engage the plurality of surgical implants such that the surgical implants are held stationary within and relative to the inner tube (figs 1-3; such as with a plurality surgical implants that are nuts). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Richart in view of Klopovic (by providing the above element within the inner tube) in order to provide a device to securely hold the implants in place such as when nuts are desired during surgical procedures, while also providing an enhanced use of such implants during procedures. For example, depending on the procedure, such as a desired quick procedure, providing the above type of holder will assist in speeding up the process while holding the elements in place and still maintaining easy and quick access.
The Combined Reference discloses:
2. The system of claim 1, wherein the plurality of surgical implants are positioned along the longitudinal axis of the holder (Klopovic figs 1-3)
3. The system of claim 1, wherein the holder has at least one cavity formed therein and configured to receive the plurality of surgical implants (cavity within fig 1 of Klopovic).
6. The system of claim 3, wherein the at least one cavity comprises a cylindrical cavity and extends along the longitudinal axis of the holder (within fig 1 of Klopovic).
7. The system of claim 6, wherein the holder has an engagement post extending along the longitudinal axis and into the cylindrical cavity, and the engagement post is configured to extend through an opening in each of the plurality of surgical implants when the plurality of surgical implants are in engagement with the holder (adjacent 9 capable of performing the above intended use of Richart).
12. The system of claim 1, wherein the outer tube, the inner tube, and the holder are configured to be coaxial with each other along the longitudinal axis of the holder when the holder is disposed within the inner tube and the inner tube is disposed within the outer tube (as in figs 1-7 of Richart).
13. An implant holding system (figs 1-8), comprising: an outer tube (4) having a sealed first outer end and an open second outer end (adjacent top and bottom), the outer tube having a removable outer cap configured to selectively seal the second outer end (3 capable of performing the above intended use); an inner tube configured to be disposed within the outer tube (adjacent 2 capable of performing the above intended use), the inner tube having a sealed first inner end configured to contact the outer cap of the outer tube, the inner tube having an open second inner end and a removable inner cap configured to selectively seal the second inner end (portion adjacent 3 capable of performing the above intended use); a plurality of surgical implants [5; The Office notes that Applicant discloses that the implants can be either screws or nuts, such as in claim 14 and that the prior art also states “Said article can be, for example, a solid component, such as a surgical screw, or any other type of article, in particular any other type of implant. In addition, said article can be a liquid or a powder” paragraph 52; though not required, the Office merely notes that washers and nuts are common implants and it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the type of implant to that of a washer or nut in order to provide an element that functions for a desired procedure such as by providing the capability of fastening a screw in place;
The Office further notes that the prior art appears to disclose a singular implant contained therein; it is well within the skill of one of ordinary skill in the art to provide multiple implants as for example if the procedure that the device is being used for required multiple implants; further, having multiple implants available together will speed up and enhance the surgical procedure; though not required, the Office merely notes to expedite prosecution for Applicant that it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device (such as with multiple implants) because it has been held that the duplication of parts on the basis of its suitability for the intended use was an obvious extension of the prior teachings. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)];
with the exception of the following which is disclosed by Klopovic: a holder configured to be disposed within the inner tube, the holder having a longitudinal axis extending between first and second holder ends, and a lumen extending at least partially therethrough from the second holder end toward the first holder end, the lumen being configured to receive the plurality of surgical implants therein in an engagement fit such that an orientation of each of the plurality of surgical implants relative to the holder is maintained when the plurality of surgical implants are received in the lumen (figs 1-3 provides a holder such as with a plurality surgical implants that are nuts, with a lumen/cavity between the top and bottom). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Richart in view of Klopovic (by providing the above element within the inner tube) in order to provide a device to securely hold the implants in place such as when nuts are desired during surgical procedures, while also providing an enhanced use of such implants during procedures. For example, depending on the procedure, such as a desired quick procedure, providing the above type of holder will assist in speeding up the process while holding the elements in place and still maintaining easy and quick access.
The Combined Reference discloses:
14. The system of claim 13, wherein the plurality of surgical implants comprise one of a plurality of set screws or a plurality of nuts (Klopovic nuts in fig 1).
15. The system of claim 13, wherein an engagement post extends along the longitudinal axis of the holder at least partially into the lumen from the first holder end toward the second holder end, and the engagement post is configured to engage each of the plurality of surgical implants (adjacent 9 capable of performing the above intended use of Richart).
16. The system of claim 13, wherein the plurality of surgical implants are positioned along the longitudinal axis of the holder (Klopovic in fig 1).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over the Combined Reference as applied to claim 7 above, and further in view of Borgeat (2413858).
The Combined Reference discloses the claimed invention above with the exception of the following which is disclosed by Borgeat: wherein the engagement post is configured to be at least partially retractable out of the cylindrical cavity and into the holder during loading and unloading of the plurality of surgical implants (such as adjacent 36 in fig 4). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the Combined Reference in view of Borgeat (by permitting extension of the above element) in order to provide enhanced access of the contents and/or provide handling.
Claim(s) 4, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over the Combined Reference as applied to claim 3, 13 above, and further in view of Bagozzi (8292174).
The Combined Reference discloses the claimed invention above with the exception of the following which is disclosed by Bagozzi: wherein the holder has a window extending through a sidewall of the holder from an outer surface of the holder to the at least one cavity such that the plurality of surgical implants is visible through the window, wherein the holder has a window extending through a sidewall of the holder from an outer surface of the holder to the lumen such that the plurality of surgical implants is visible through the window (elements adjacent 403). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the Combined Reference in view Bagozzi (by providing an opening in the holder) in order to permit desired sterilization of the elements.
Response to Arguments
Applicant's arguments filed 03/01/2024 have been fully considered but they are not persuasive.
In response to applicant's argument that the prior art is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the prior art is to both containers, holding systems for internal contents that are for easy and quick access and therefore the prior art is indeed analogous.
Applicant states that the Office did not provide a reason to duplicate. The Office further notes that the prior art appears to disclose a singular implant contained therein; it is well within the skill of one of ordinary skill in the art to provide multiple implants as for example if the procedure that the device is being used for required multiple implants; further, having multiple implants available together will speed up and enhance the surgical procedure; though not required, the Office merely notes to expedite prosecution for Applicant that it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device (such as with multiple implants) because it has been held that the duplication of parts on the basis of its suitability for the intended use was an obvious extension of the prior teachings. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Klopovic discloses a holder configured to be disposed within the inner tube, the holder having a longitudinal axis extending between first and second holder ends, and a lumen extending at least partially therethrough from the second holder end toward the first holder end, the lumen being configured to receive the plurality of surgical implants therein in an engagement fit such that an orientation of each of the plurality of surgical implants relative to the holder is maintained when the plurality of surgical implants are received in the lumen (figs 1-3 provides a holder such as with a plurality surgical implants that are nuts, with a lumen/cavity between the top and bottom). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Richart in view of Klopovic (by providing the above element within the inner tube) in order to provide a device to securely hold the implants in place such as when nuts are desired during surgical procedures, while also providing an enhanced use of such implants during procedures. For example, depending on the procedure, such as a desired quick procedure, providing the above type of holder will assist in speeding up the process while holding the elements in place and still maintaining easy and quick access.
Applicant then states that medication renders the primary reference inoperable for its intended purpose. The Office notes that the intended purpose is to contain elements in a manner that provide easy and quick access. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Richart in view of Klopovic (by providing the above element within the inner tube) in order to provide a device to securely hold the implants in place such as when nuts are desired during surgical procedures, while also providing an enhanced use of such implants during procedures. For example, depending on the procedure, such as a desired quick procedure, providing the above type of holder will assist in speeding up the process while holding the elements in place and still maintaining easy and quick access. Therefore, the intended purpose is enhanced.
Accordingly, Applicant/Appellant has not demonstrated error in the factual findings or reasoning set forth by the Office and the Office must maintain the 103 rejections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW D PERREAULT whose telephone number is (571)270-5427. The examiner can normally be reached Monday - Friday 7:00am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anthony Stashick can be reached on (571)272-4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW D PERREAULT/Primary Examiner, Art Unit 3735
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