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 09 December 2025. As directed by the amendment: claims 1-13 have been amended, and claims 14-20 stand withdrawn. Claims 1-20 currently stand pending in the application.
The replacement drawing sheets are sufficient to overcome the drawing objection related to dark shading. The amendments to the claims are sufficient to overcome the remaining drawing objections. The drawing objections are accordingly withdrawn.
The amendments to the claims are not sufficient to overcome the specification objection listed in the previous action, which is repeated below in relevant part.
The amendments to the claims are not sufficient to overcome the claim objections listed in the previous action, which are repeated below in relevant part, in addition to further claim objections as necessitated by the claim amendments.
The amendments to the claims are not sufficient to overcome the rejections under 35 U.S.C. 112(b) listed in the previous action, which are repeated below in relevant part, in addition to further rejections under 35 U.S.C. 112(b) as necessitated by the claim amendments.
Response to Arguments
Applicant's arguments filed 09 December 2025 with respect to the rejection of claim 1 under 35 U.S.C. 102(a)(1)/(2) have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
As to the rejection of claims 4-6 under 35 U.S.C. 102(a)(1)/(2), in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the sleeve is a distinct structural component that receives and surrounds elongated member 304; the groove for engaging the articular surface of the prosthesis is formed by the annular or circumferential space between the outer surface of elongated member and the inner surface of sleeve) 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).
Applicant's arguments with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive. As to Supinski (US 2003/0088315), Applicant contends that Supinski does not teach a clamp and therefore there would be no reasonable motivation to combine. Examiner respectfully submits that the structure of the clamp is disclosed by Brown (US 2008/0097450) and that Supinski is relied upon simply as a teaching of a thickness of a patella replacement device for use in Brown’s clamp, i.e. to be clamped by Brown’s clamp.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The structure of the clamp is disclosed by Brown in view of Wallace (U.S. 10,085,758). Manson (US 2022/0142683) was relied upon as a teaching of fabricating a medical instrument from medical grade polymer. As articulated by Applicant, the use of medical-grade polymer for medical instruments is well-known in the art. Manson was relied upon simply as one teaching of such use of medical-grade polymer for medical instruments.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification fails to provide proper antecedence for “the release mechanism comprises a spring” (claim 6 / line 4). While the specification recites that the dogs are biased into the slots, the specification is silent as to the release mechanism comprising a spring that biases the pair of dogs into corresponding slots. Rather, the specification recites that the release mechanism 318 can be pressed to move the dogs out of locking engagement with the slots. There is no mention of a spring, or that the release mechanism comprises the spring. See the below claim objections to claims 1 and 6 for suggested language.
Claim Objections
Claims 1-13 are objected to because of the following informalities: improper antecedence and typographical errors. Appropriate correction is required. The following amendments are suggested:
Claim 1 / lines 22-25: “wherein are biased into a corresponding pair of the plurality of slots on the pair of tension components and wherein the release mechanism releases the pair of dogs from the engaged pair of slots”
Claim 1 / line 29: “the applied compressive force is configured to be retained”
Claim 4 / line 8: “which prosthesis is configured to be cemented”
Claim 4 / line 13: “the first or the second member”
Claim 4 / line 19: “the applied compressive force is configured to be retained”
Claim 6 / lines 3-6: “and wherein is biased into one slot of the plurality of slots, and wherein the release mechanism releases the dog from the one of the plurality of slots.”
Claim 8 / lines 1-2: “each of the first and second
Claim 8 / line 3: “[[an]] the one end of the first or the second elongated member.”
Claim 10 / line 2: “adjacent [[an]] the one end”
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 1-13 are 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 1, the specification is silent as to the second elongated member being parallel to the first elongated member.
As to claim 4, the specification is silent as to a sleeve and a groove in a surface of the second member. Rather, the specification recites these as alternatives, i.e. either a sleeve that slides over the second member to create a groove, or alternately, a groove in the second member itself (par. [0043]).
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 1-13 are 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 1, the limitation “which spring” (line 24) renders the claims indefinite because it lacks proper antecedent basis in the claims. For examination purposes, the limitation will be interpreted as “wherein the release mechanism”.
As to claim 4, the limitation “a first member” (line 6) renders the claims indefinite because it is unclear if this refers back to the previously recited first member (line 3) or to a different first member. For examination purposes, the limitation will be interpreted as “the first member”.
As to claim 11, the limitation “the surface artifact” (line 1) renders the claims indefinite because it lacks proper antecedent basis in the claims. For examination purposes, the limitation will be interpreted as “the groove”. Since a depression is not further limiting to a groove, the claim will be interpreted as follows, and amendment is suggested to: “wherein the groove is and the at least [[a]] the portion of the articular surface of the patellar prosthesis is configured to reside in the groove.”
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “artifact” in claim 11 is used by the claim to mean “depression or groove,” while the accepted meaning is “an object made by a human being with cultural or historical interest.” The term is indefinite because the specification does not clearly redefine the term.
As to claim 12, the limitation “a groove” renders the claim indefinite, because it is unclear if this refers back to the previously recited groove in claim 4, or to a different groove. For examination purposes, the limitation will be interpreted as “the groove”. Since a depression is not further limiting to a groove and should be deleted in the previous claim 11 as proposed above, claim 12 would be correspondingly amended to read “wherein the
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
Claims 11-13 are rejected under 35 U.S.C. 101 because they are drawn to non-statutory subject matter. In claim 11, lines 2-3, applicant positively recites part of a human, i.e. "in which at least a portion of the articular surface of the prosthesis resides” and in claim 12 / lines 2-3, applicant positively recites part of a human, i.e. “in which the at least the portion of the articular surface of the prosthesis resides”. Thus claims 11-13 include a human within their scope and are non-statutory.
A claim directed to or including within its scope a human is not considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970).
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 4-6 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent Application Publication No. US 2008/0097450 to Brown et al. (hereinafter, “Brown”).
As to claim 4, Brown discloses a clamp for compressing a cemented patella/prosthesis combination (interpreted as language of intended use and deemed anticipated by the prior art if capable of said intended use; the clamp is fully capable of compressing any device inserted therein, including a cemented patella/prosthesis combination), comprising: a first member (90) having a surface adapted to contact an anterior surface of a resurfaced patella (interpreted as language of intended use; a surface of 90 is fully capable of contacting an anterior surface of the resurfaced patella if placed adjacently), FIG. 1; a sleeve (26) (par. [0028]); a second member (60) separable from a first member (at least during disassembly, par. [0032]), FIG. 1, and having a surface with a groove (concavity in 60 that engages bone as shown in FIG. 2) shaped to engage at least a portion of an articular surface of a patellar prosthesis (interpreted as language of intended use; the surface/groove is fully capable of engaging at least a portion of an articular surface of the prothesis if placed adjacently) (par. [0030]), which prosthesis is cemented to the resurfaced patella (interpreted as language of intended use); a tension component (30) coupled to one end (end of the second member 60 at 70s) or edge of the first or the second member, the tension component extending away from the respective member substantially perpendicularly to the surface of the respective member to which the tension component is coupled, FIG. 2; a retention mechanism (102) associated with the first or second member (first member 90) that does not have the tension component coupled thereto, the retention mechanism comprising an interior surface (interior surface facing 30, or interior to 30) that engages an exterior surface on the tension component (par. [0032]); and wherein when the first member contacts the anterior surface of the resurfaced patella and when the second member engages the articular surface of the patellar prosthesis (interpreted as language of intended use), and when a compressive force is applied between the first and second members (90 moved closer to 60), at least a portion of the applied compressive force is retained in the clamp by the retention mechanism reacting against the tension component to lock the retained compressive force across the cemented patella/prothesis combination.
As to claim 5, Brown discloses the clamp of claim 4, further comprising a release mechanism (100), wherein the release mechanism is operatively coupled to the retention mechanism to selectively release the retained compressive force (par. [0032]).
As to claim 6, Brown discloses the clamp of claim 5, wherein the tension component comprises a plurality of spaced apart slots (34) along a length of the tension component (par. [0028], [0032]), FIG. 1, wherein the retention mechanism comprises a dog (104) sized and shaped to engage the plurality of slots (par. [0032]), and wherein the release mechanism comprises a spring (100) that biases the dog into one slot of the plurality of slots, and wherein the spring is overcome when releasing the dog from the one of the plurality of slots (par. [0032]).
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2008/0097450 to Brown et al. (hereinafter, “Brown”) in view of U.S. Patent No. U.S. 10,085,758 to Wallace et al. (hereinafter, “Wallace”).
As to claim 1, Brown discloses a clamp for maintaining pressure across a prosthesis cemented to a resurfaced patella (interpreted as language of intended use and deemed anticipated by the prior art if capable of said intended use; the clamp is fully capable of maintaining pressure across any device inserted therein, including a prosthesis cemented to a resurfaced patella), comprising: a first elongated member (40) having a surface adapted to contact an anterior surface of the resurfaced patella (interpreted as language of intended use; surface 44 of 40 is fully capable of contacting an anterior surface of the resurfaced patella if placed adjacently) (par. [0029]), FIGS. 1-2; a second elongated member (60) parallel to the first elongated member (longitudinal axes of the elongated members are parallel to each other), configured to engage at least a portion of an articular surface of the prosthesis (interpreted as language of intended use; a surface of 60 is fully capable of engaging at least a portion of an articular surface of the prothesis if placed adjacently) (par. [0030]); a pair of tension components (30) secured to one end of the first elongated member (30s are secured to one end of 40 by passing through sleeves 50, par. [0029]) and spaced apart from one another, FIGS. 1-2, each tension component of the pair of tension components extending substantially perpendicularly away from the first elongated member, FIGS. 1-2, each tension component of the pair of tension components having a plurality of slots (34) formed along an outer surface (par. [0028], [0032]), FIG. 1; a pair of retention members (96) coupled to the second elongated member (coupled as parts of the assembled whole, since 90 is coupled to 60 via 30s) at one end of the second elongated member, FIG. 2, and spaced apart from one another such that each of the pair of tension components can be received in a corresponding one of the pair of retention members at the same time (par. [0032]); a lock (102s) operatively coupled with the pair of retention members (operatively coupled as part of the functional whole device) and comprising a pair of dogs (104) sized and shaped to engage the slots in the pair of tension components to thereby hold the first and second elongated members in relative position to one another (par. [0032]); a release mechanism (100) operatively coupled to the lock, wherein the release mechanism biases the pair of dogs into a corresponding pair of plurality of slots on the pair of tension components and which spring may be overcome to release the pair of dogs from the engaged pair of slots (par. [0032]); and wherein when the clamp is placed about a cemented prosthesis/patella combination comprising the prosthesis cemented to the resurfaced patella (interpreted as language of intended use), and when a compressive force is applied to the first and second elongated members (40 moved closer to 60), at least a portion of the applied compressive force is retained in the clamp by the pair of dogs engaging the pair of the plurality of slots.
Brown is silent as to a sleeve, wherein the second elongated member fits into the sleeve and is spaced therefrom to form a groove, wherein the groove is configured to engage at least a portion of an articular surface of the prosthesis.
Brown contemplates using different sizes of second elongated member to accommodate different sized patellae (par. [0044]).
Wallace teaches a way to couple different ends to an elongated member, by providing a sleeve (14; comprises a sleeve due to sleeved shape of slot 102), FIGS. 1-8, wherein an elongated member (104 of 32), FIG. 10, fits into the sleeve (col. 7 / line 62 – col. 8 / line 13), FIG. 11, and is spaced therefrom to form a groove (indent between 32 and 14), FIG. 9.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Brown to include a sleeve at the end of the second elongated member to provide the desired size to accommodate a particular patella, wherein an end of the second elongated member fits into the sleeve, as taught by Wallace, to allow for a different size of the sleeve to accommodate different sized patellae to be quickly coupled and released/exchanged, without having to completely disassemble the clamp, therefore providing flexibility to the system as contemplated by Brown (par. [0044]). As taught by Wallace, the second elongated member is spaced from the sleeve to form a groove (indent), wherein the groove is fully capable of engaging at least a portion of an articular surface of the prosthesis (interpreted as language of intended use; the groove is fully capable of engaging at least a portion of an articular surface of the prosthesis of a complementary size and positioning).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Brown in view of Wallace (hereinafter, “Brown/Wallace”), as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. US 2003/0088315 to Supinski.
As to claim 2, Brown discloses wherein the plurality of slots (34) placed along the tension components is configured to clamp cemented prosthesis/patella combinations having thicknesses, but is silent as to the thicknesses being between 0.6 inches and 1.2 inches, inclusive.
Supinski teaches that a patella replacement device could have a thickness of 0.709 inches (par. [0018]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide slots placed along the tension components configured to clamp cemented prosthesis/patella combinations having a thickness of 0.709 inches (which is between 0.6 inches and 1.2 inches), since Supinski teaches that this is a typical thickness of a patella replacement device, and the cemented prosthesis/patella combination also serves as a patella replacement device. Discovering an optimum value of a result effective variable involves only routine skill in the art.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Brown/Wallace in view of Supinski (hereinafter, “Brown/Wallace/Supinski”), as applied to claim 2 above, and further in view of U.S. Patent Application Publication No. US 2022/0142683 to Manson et al. (hereinafter, “Manson”).
Brown/Wallace/Supinski are silent as to wherein the elongated members, the tension components and the retention members are fabricated from medical grade polymer.
Manson teaches that a clamp is fabricated from medical grade polymer (col. 23 / lines 1-7).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to fabricate the clamp of Brown/Wallace/Supinski, including its elongated members, tension components and retention members, from medical grade polymer, since Manson teaches that a medical clamp can be fabricated from medical grade polymer for strength, biocompatibility, cost and other reasons, and it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Brown.
As to claim 7, Brown discloses wherein the plurality of slots are shaped such that the dog engages the one slot of the plurality of slots and restrains movement of the tension component (relative to 90) (par. [0032]).
As to claim 8, Brown discloses wherein each of the first and second elongated members is elongated, FIG. 1, and wherein the tension component is coupled to an end (end of 60 at 70s) of the elongated member, FIG. 1.
Brown is silent as to restraining movement in only one direction.
Brown contemplates that the first member (90) is adjustably mounted via a ratchet adjustment (par. [0024]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to adjustably mount the first member via a ratchet adjustment, since Brown contemplates such a ratchet adjustment and the one-way translation allowed for by a ratchet adjustment (as the term ratchet is commonly understood) would allow easy positional adjustment of the first member using macro movements, e.g. proximal movement to adjust to the desired height, while preventing distal movement of the first member, unless the release mechanism is engaged to allow the first member to move distally (by disengaging the ratchet), so as to prevent unintentional disengagement of the first member completely off of the tension components. The slots would be shaped or angled in a sawtooth shape, for example, to allow the dog to slide over the slots in the proximal direction, but would restrain movement of the dog in only the distal direction (unless the dog is disengaged from the slots). Restraining movement of the dog relative to the tension component would result in corresponding restrained movement of the tension component relative to the dog.
Claims 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Brown in view of Supinski.
As to claim 9, Brown discloses wherein the plurality of slots (34) is configured to clamp cemented patella/prosthesis combinations having thicknesses.
As to claim 10, Brown discloses clamp of claim 9, wherein the tension component is coupled to and adjacent an end (end of 60 at 70s) of the second elongated member (par. [0028], [0030]), FIG. 1, and wherein the retention mechanism is coupled to and adjacent to one end of the first elongated member, FIG. 1.
As to claim 11, Brown discloses clamp of claim 10, wherein the surface artifact is a depression formed in the second elongated member, FIG. 2, in which at least a portion of the articular surface of the prosthesis resides (interpreted as language of intended use).
As to claim 12, Brown discloses clamp of claim 11, wherein the depression is a groove formed in the second elongated member, FIG. 2, in which the at least the portion of the articular surface of the prosthesis resides (interpreted as language of intended use).
As to claim 13, Brown discloses clamp of claim 11, wherein the tension component comprises first and second tension components (30), FIG. 1, wherein the retention mechanism comprises first and second retention mechanisms (102), FIG. 1, that are shaped to receive (in frictional engagement), respectively, the first and second tension components, and wherein the release mechanism (100) is disposed between the first and second retention mechanisms, FIG. 1.
Brown is silent as to the thicknesses being between 0.6 inches and 1.2 inches, inclusive.
Supinski teaches that a patella replacement device could have a thickness of 0.709 inches (par. [0018]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide slots placed along the tension components sufficient to clamp cemented prosthesis/patella combinations having a thickness of 0.709 inches (which is between 0.6 inches and 1.2 inches), since Supinski teaches that this is a typical thickness of a patella replacement device, and the cemented prosthesis/patella combination also serves as a patella replacement device. Discovering an optimum value of a result effective variable involves only routine skill in the art.
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