DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
The amendments, dated 5/13/2026, have overcome:
The objection(s) to claim(s) 10, 15, 6, 13, 18;
The rejection of claim(s) 6-9, 13-19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph;
The rejection of claim(s) 1-20 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) based on Duggal et al. (US 2011/0166609 A1 – as previously cited);
The aforementioned objections/ rejections have been withdrawn.
Claim Rejections - 35 USC § 112
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(s) 6, 12-19, 21 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Within claim 6, line 1: Applicant claims, “the bottom portion”; it is unclear, and therefore indefinite, which bottom portion is being referred to – the bottom portion of the first implant component or the second implant component? For the purposes of examination, Examiner is assuming the aforementioned claim clause should be replaced with –the bottom portion of the first implant component--. Claim(s) 7-9, which depend from claim 6, inherit all the problems associated with claim 6.
Claim 18 recites the limitation "the first implant component" in line 7. There is insufficient antecedent basis for this limitation in the claim. Claim(s) 19, 21, which depend from claim 18, inherit all the problems associated with claim 18.
Claim 18 recites the limitation "the second implant component" in lines 14-15. There is insufficient antecedent basis for this limitation in the claim.
Within claim 18, lines 16-17: Applicant claims, “the first component and the second component are each configured to couple with at least a portion of a talus and a calcaneum of a patient”; it is unclear, and therefore indefinite, if the talus and the calcaneum (from the aforementioned claim requirement) are redefining the first and second bones (from claim 18, liens 34 and 10-11) OR in addition to the first and second bones (from claim 18, liens 34 and 10-11).
Claim 12 depends from cancelled claim 10. For the purposes of examination Examiner is assuming claim 12 should depend from claim 1. Claim(s) 13, which depend from claim 12, inherit all problems associated with claim 12.
Claim 14 depends from cancelled claim 10. For the purposes of examination Examiner is assuming claim 14 should depend from claim 1. Claim(s) 115-17, which depend from claim 14, inherit all problems associated with claim 14.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 4-9, 12-21 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Perier et al. (US 2020/0078064 A1).
With respect to claim 1.
Perier et al. discloses a subtalar joint implant system (bone attachment system 100), as can be seen in fig. 2, comprising:
a first implant component (middle component 200) (paragraph [0049]); and
a second implant component (proximal component 210) (paragraph [0049]);
wherein the first implant component (middle component 200), as can be seen in greater detail in figs. 3-5, comprises:
a top portion (middle component attachment end 220 OR middle component bone fastener 228) (paragraph [0051]); and
a bottom portion (the other of middle component attachment end 220 OR middle component bone fastener 228) (paragraph [0051]);
wherein the top portion (middle component attachment end 220 OR middle component bone fastener 228) and the bottom portion (the other of the middle component attachment end 220 OR middle component bone fastener 228) are coupled with one another and are configured about a common longitudinal axis (axis 300) (paragraph [0060]), and wherein the top portion (middle component attachment end 220 OR middle component bone fastener 228) and the bottom portion (the other of the middle component attachment end 220 OR middle component bone fastener 228) of the first implant component (middle component 200) are threadably couplable with one another (paragraph [0066]); and
wherein the second implant component (proximal component 210), as can be seen in greater detail in figs. 6-7, comprises:
a top portion (proximal component attachment end 230 OR proximal component bone fastener 238) (paragraph [0051]); and
a bottom portion (the other of the proximal component attachment end 230 OR proximal component bone fastener 238) (paragraph [0051]);
wherein the top portion (proximal component attachment end 230 OR proximal component bone fastener 238) and the bottom portion (the other of the proximal component attachment end 230 OR proximal component bone fastener 238) are coupled with one another and are configured about a common longitudinal axis (axis 600) (paragraph [0069]), and wherein the top portion (proximal component attachment end 230 OR proximal component bone fastener 238) and the bottom portion (the other of the proximal component attachment end 230 OR proximal component bone fastener 238) of the second implant (proximal component 210) component are threadably couplable with one another (paragraph [0076]);
wherein the second implant component (proximal component 210) has a greater size (longer length) than the first implant component (middle component 200) (as can be seen in fig. 2).
With respect to claim 4:
Wherein the top portion (middle component attachment end 220) of the first implant component (middle component 200) comprises an engagement feature (plateau 240) (paragraph [0059]).
With respect to claim 5:
Wherein the engagement feature (plateau 240) of the top portion (middle component attachment end 220) of the first implant component (middle component 200) comprises an interface (dovetail shape of end 370 and sides 374) which is configured to engage (is capable of engaging) with one or more instruments (an instrument is capable of engaging the dovetail shape of end 370 and sides 374) configured to facilitate implantation of the first implant component (middle component 200) (paragraph [0064]).
With respect to claim 6:
Wherein the bottom portion (middle component bone fastener 228) of the first implant component (middle component 200) comprises:
a threading (threads 226) disposed on at least a portion of an outer surface thereof (paragraph [0051]); and
an engagement feature (socket 350) disposed on an end portion of the bottom portion (middle component bone fastener 228), wherein the engagement feature (socket 350) of the bottom portion (middle component bone fastener 228) of the first implant component (middle component 200) is configured to engage with one or more instruments configured to facilitate implantation of the bottom portion (middle component bone fastener 228) of the first implant component (middle component 200) (paragraph [0061]).
With respect to claim 7:
Wherein the top portion (middle component attachment end 220) of the first implant component (middle component 200) is configured to be implanted in at least a portion of a talus of a patient. (PLEASE NOTE: With respect to claim 7: Applicant claims: “top portion of the first implant component is configured to be implanted in at least a portion of a talus of a patient”; this is intended use language. A recitation of the intended use of the claimed invention/ structure must result in a structural difference between the claimed invention/ structure and the prior art in order to patentably distinguish the claimed invention/ structure from the prior art. If the prior art structure is capable of performing the intend use, then it meets the claim. Examiner is considering the middle component attachment end (220), as disclosed by Perier et al., as capable of being implanted in at least a portion of the talus, as disclosed by Perier et al., as it is made from a material and is of a size that a surgeon could choose to implant the structure in the claimed manner.)
With respect to claim 8:
Wherein the bottom portion (middle component bone fastener 228) of the first implant component (middle component 200) is configured to be implanted in at least a portion of a calcaneum of the patient. (PLEASE NOTE: With respect to claim 8: Applicant claims: “the bottom portion of the first implant component is configured to be implanted in at least a portion of a calcaneum of the patient”; this is intended use language. A recitation of the intended use of the claimed invention/ structure must result in a structural difference between the claimed invention/ structure and the prior art in order to patentably distinguish the claimed invention/ structure from the prior art. If the prior art structure is capable of performing the intend use, then it meets the claim. Examiner is considering the middle component bone fastener (228), as disclosed by Perier et al., as capable of being implanted in at least a portion of the calcaneum, as disclosed by Perier et al., as it is made from a material and is of a size that a surgeon could choose to implant the structure in the claimed manner.)
With respect to claim 9:
Wherein the bottom portion (middle component bone fastener 228) of the first implant component (middle component 200) is configured to be implanted in at least a portion of a posterior facet of the calcaneum of the patient. (PLEASE NOTE: With respect to claim 9: Applicant claims: “the bottom portion of the first implant component is configured to be implanted in at least a portion of a posterior facet of the calcaneum of the patient”; this is intended use language. A recitation of the intended use of the claimed invention/ structure must result in a structural difference between the claimed invention/ structure and the prior art in order to patentably distinguish the claimed invention/ structure from the prior art. If the prior art structure is capable of performing the intend use, then it meets the claim. Examiner is considering middle component bone fastener (228), as disclosed by Perier et al., as capable of being implanted in at least a portion of the posterior facet of the calcaneum, as disclosed by Perier et al., as it is made from a material and is of a size that a surgeon could choose to implant the structure in the claimed manner.)
With respect to claim 12:
Wherein the top portion (proximal component attachment end 230) of the second implant component (proximal component 210) comprises an engagement feature (slot 250) (paragraph [0071]).
With respect to claim 13:
Wherein the engagement feature (slot 250) of the top portion (proximal component attachment end 230) of the second implant component (proximal component 210) comprises an interface (dovetail shape of end 680 and sides 674) which is configured to engage (is capable of engaging) with one or more instruments (an instrument is capable of engaging the dovetail shape of end 680 and sides 674) configured to facilitate implantation of the second implant component (proximal component 210) (paragraph [0072]).
With respect to claim 14:
Wherein the bottom portion (proximal component bone fastener 238) of the second implant component (proximal component 210) comprises:
a threading (threads 236) disposed on at least a portion of an outer surface thereof (paragraph [0051]); and
an engagement feature (socket 350) disposed on an end portion of the bottom portion (proximal component bone fastener 238), wherein the engagement feature (socket 350) of the bottom portion (proximal component bone fastener 238) of the second implant component (proximal component 210) is configured to engage with one or more instruments configured to facilitate implantation of the second bottom portion of the second implant component (proximal component 210) (paragraph [0061]).
With respect to claim 15:
Wherein the top portion (proximal component attachment end 230) of the second implant component (proximal component 210) is configured to be implanted in at least a portion of a talus of a patient. (PLEASE NOTE: With respect to claim 15: Applicant claims: “top portion of the second implant component is configured to be implanted in at least a portion of a talus of a patient”; this is intended use language. A recitation of the intended use of the claimed invention/ structure must result in a structural difference between the claimed invention/ structure and the prior art in order to patentably distinguish the claimed invention/ structure from the prior art. If the prior art structure is capable of performing the intend use, then it meets the claim. Examiner is considering the proximal component attachment end (230), as disclosed by Perier et al., as capable of being implanted in at least a portion of the talus, as disclosed by Perier et al., as it is made from a material and is of a size that a surgeon could choose to implant the structure in the claimed manner.)
With respect to claim 16:
Wherein the bottom portion (proximal component bone fastener 238) of the second implant component (proximal component 210) component is configured to be implanted in at least a portion of a calcaneum of the patient. (PLEASE NOTE: With respect to claim 16: Applicant claims: “the bottom portion of the second implant component is configured to be implanted in at least a portion of a calcaneum of the patient”; this is intended use language. A recitation of the intended use of the claimed invention/ structure must result in a structural difference between the claimed invention/ structure and the prior art in order to patentably distinguish the claimed invention/ structure from the prior art. If the prior art structure is capable of performing the intend use, then it meets the claim. Examiner is considering the proximal component bone fastener (238), as disclosed by Perier et al., as capable of being implanted in at least a portion of the calcaneum, as disclosed by Perier et al., as it is made from a material and is of a size that a surgeon could choose to implant the structure in the claimed manner.)
With respect to claim 17:
Wherein the bottom portion (middle component bone fastener 228) of the first implant component (middle component 200) is configured to be implanted in at least a portion of a posterior facet of the calcaneum of the patient. (PLEASE NOTE: With respect to claim 17: Applicant claims: “the bottom portion of the first implant component is configured to be implanted in at least a portion of a posterior facet of the calcaneum of the patient”; this is intended use language. A recitation of the intended use of the claimed invention/ structure must result in a structural difference between the claimed invention/ structure and the prior art in order to patentably distinguish the claimed invention/ structure from the prior art. If the prior art structure is capable of performing the intend use, then it meets the claim. Examiner is considering middle component bone fastener (228), as disclosed by Perier et al., as capable of being implanted in at least a portion of the posterior facet of the calcaneum, as disclosed by Perier et al., as it is made from a material and is of a size that a surgeon could choose to implant the structure in the claimed manner.)
With respect to claim 18:
Perier et al. discloses a subtalar joint implant system (bone attachment system 100), as can be seen in fig. 2, comprising:
a first component (middle component 200) (paragraph [0049]) comprising:
a top portion (middle component attachment end 220) configured to couple to a first bone; and
a bottom portion (middle component bone fastener 228) configured to couple to a second bone;
wherein the top portion (middle component attachment end 220) and the bottom portion (middle component bone fastener 228) of the first component (middle component 200) are coupled with one another and configured about a first common longitudinal axis (axis 300) (paragraph [0060]), and wherein the top portion (middle component attachment end 220) and the bottom portion (middle component bone fastener 228) of the first implant component (middle component 200) are threadably couplable with one another (paragraph [0066]); and
a second component (proximal component 210) (paragraph [0049]) comprising:
a top portion (proximal component attachment end 230) configured to couple to the first bone; and
a bottom portion (proximal component bone fastener 238) configured to couple to the second bone:
wherein the top portion (proximal component attachment end 230) and the bottom portion (proximal component bone fastener 238) of the second component (proximal component 210) are coupled with one another and configured about a second common longitudinal axis (axis 600) (paragraph [0069]), and wherein the top portion (proximal component attachment end 230) and the bottom portion (proximal component bone fastener 238) of the second implant component (proximal component 210) are threadably couplable with one another (paragraph [0076]);
wherein the first component (middle component 200) and the second component (proximal component 210) are each configured to couple with at least a portion of a talus and a calcaneum of a patient; and
wherein the second implant component (proximal component 210) has a greater size (longer length) than the first implant component (middle component 200) (as can be seen in fig. 2).
(PLEASE NOTE: With respect to claim 18: Applicant claims: “top portion configured to couple to a first bone; and a bottom portion configured to couple to a second bone” and “the first component and the second component are each configured to couple with at least a portion of a talus and a calcaneum of a patient”; this is intended use language. A recitation of the intended use of the claimed invention/ structure must result in a structural difference between the claimed invention/ structure and the prior art in order to patentably distinguish the claimed invention/ structure from the prior art. If the prior art structure is capable of performing the intend use, then it meets the claim. Examiner is considering the structures, as disclosed by Perier et al., as capable of being implanted in the claimed manner as the structures are made from a material and is of a size that a surgeon could choose to implant the structure in the claimed manner.)
With respect to claim 19:
Wherein the first component (middle component 200) is configured to couple with at least a portion of a posterior facet of the calcaneum of the patient and the second component (proximal component 210) is configured to couple with at least a portion of a middle facet of the calcaneum of the patient.
(PLEASE NOTE: With respect to claim 19: Applicant claims: “the first component is configured to couple with at least a portion of a posterior facet of the calcaneum of the patient and the second component is configured to couple with at least a portion of a middle facet of the calcaneum of the patient.”; this is intended use language. A recitation of the intended use of the claimed invention/ structure must result in a structural difference between the claimed invention/ structure and the prior art in order to patentably distinguish the claimed invention/ structure from the prior art. If the prior art structure is capable of performing the intend use, then it meets the claim. Examiner is considering structures, as disclosed by Perier et al., as capable of being implanted in the claimed manner as the structures are made from a material and is of a size that a surgeon could choose to implant the structure in the claimed manner.)
With respect to claim 20:
Perier et al. discloses a subtalar implant system, comprising:
a first component (middle component 200), comprising a threading (threads 226) disposed on at least a portion of an exterior surface thereof (paragraph [0051]); and
a second component (proximal component 210), comprising a threading (threads 236) disposed on at least a portion of an exterior surface thereof (paragraph [0051]);
wherein the first and second components (middle component 200 and proximal component 210) are each configured to couple with at least a portion of a talus and a calcaneum of a patient;
wherein the first component (middle component 200) is configured to couple with at least a portion of a posterior facet of the calcaneum of the patient and the second component (proximal component 210) is configured to couple with at least a portion of a middle facet of the calcaneum of the patient; and
the second implant component (proximal component 210) has a greater size (longer length) than the first implant component (middle component 200) (as can be seen in fig. 2).
(PLEASE NOTE: With respect to claim 20: Applicant claims: “the first component is configured to couple with at least a portion of a posterior facet of the calcaneum of the patient and the second component is configured to couple with at least a portion of a middle facet of the calcaneum of the patient.”; this is intended use language. A recitation of the intended use of the claimed invention/ structure must result in a structural difference between the claimed invention/ structure and the prior art in order to patentably distinguish the claimed invention/ structure from the prior art. If the prior art structure is capable of performing the intend use, then it meets the claim. Examiner is considering structures, as disclosed by Perier et al., as capable of being implanted in the claimed manner as the structures are made from a material and is of a size that a surgeon could choose to implant the structure in the claimed manner.)
With respect to claim 21:
Wherein the second implant component (proximal component 210) component has a diameter (diameter of the proximal component attachment end 230) greater than a diameter (diameter of the middle component bone fastener 228) of the first implant component (middle component 200), as can be seen in the figures.
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 REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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REBECCA STRASZHEIM PRESTON
Primary Examiner
Art Unit 3774
/REBECCA S PRESTON/ Primary Examiner, Art Unit 3774
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