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 .
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.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pak et al. (US 2023/0255665 A1; cited by Applicant).
Regarding claim 1, Pak et al. disclose a system for increasing biological activity within a patient (para. 0086), comprising:
a housing 300 (Fig. 5A);
a drive 360, 346, 344 (Fig. 4F) carried within the housing;
an indexing contour 330 (Figs. 4H, 5A; para. 0059) carried by the housing and configured to substantially stabilize the housing in relation to a transport device base 215 (Fig. 3B) of a transport device 200 (id.) configured to move a growth stimulator (bone pins attached to rings 20, 30 attached to the transport device 200; paras. 0039 and 0086; Fig. 1) in relation to a bone of a subject;
a locking portion 336 (Fig. 5A; para. 0059) configured to releasably lock the housing to the transport device base;
a rotatable mating tool 342 (para. 0061) carried by the housing, wherein the drive is configured to cause the rotatable mating tool to rotate, and wherein the rotatable mating tool is configured to be rotationally coupled to a screw drive 220 (i.e., a drive that drives the leadscrew) of a leadscrew 250 (Fig. 3B) of the transport device when the housing is stabilized with the transport device base via the indexing contour and is locked to the transport device base via the locking portion; and
a control unit 250 (para. 0060) configured to output a control signal (electronic signal from a PCB; id.) configured to direct the drive to rotate the rotatable mating tool (id. and para. 0061).
Regarding claim 2, Pak et al. disclose a method for increasing biological activity within a patient (para. 0086), comprising:
providing a system comprising:
a housing 300 (Fig. 5A);
a drive 360, 346, 344 (Fig. 4F) carried within the housing;
an indexing contour 330 (Figs. 4H, 5A; para. 0059) carried by the housing and configured to substantially stabilize the housing in relation to a transport device base 215 (Fig. 3B) of a transport device 200 (id.) configured to move a growth stimulator (bone pins attached to rings 20, 30 attached to the transport device 200; paras. 0039 and 0086; Fig. 1) in relation to a bone of a subject;
a locking portion 336 (Fig. 5A; para. 0059) configured to releasably lock the housing to the transport device base;
a rotatable mating tool 342 (para. 0061) carried by the housing, wherein the drive is configured to cause the rotatable mating tool to rotate, and wherein the rotatable mating tool is configured to be rotationally coupled to a screw drive 220 (i.e., a drive that drives the leadscrew) of a leadscrew 250 (Fig. 3B) of the transport device when the housing is stabilized with the transport device base via the indexing contour and is locked to the transport device base via the locking portion; and
a control unit 250 (para. 0060) configured to output a control signal (electronic signal from a PCB; id.) configured to direct the drive to rotate the rotatable mating tool (id. and para. 0061);
surgically securing the transport device base 215 (Fig. 3B) to the bone of the subject (via rings 20, 30 attached to the bone pins; paras. 0039 and 0086; Fig. 1);
surgically placing the growth stimulator (bone pins; supra) within the patient (i.e., the bone pins are surgically placed within the bone of the patient) and coupling the growth stimulator to the transport device base 215 such that it is displaceable relative to the transport device base 215 via rotation of the leadscrew 250 (Fig .3B);
engaging the indexing contour 330 (Figs. 4H, 5A; para. 0059) of the housing 300 with the transport device base 215 (Figs 3B and 5A);
locking the housing 300 to the transport device base 215 via the locking portion 336 (Fig. 5A; para. 0059);
coupling the rotatable mating tool 342 (para. 0061) to the screw drive 220 of the leadscrew 250 (Fig. 3B); and
initiating the control signal via the control unit 250 (para. 0060) to cause the rotatable mating tool 342 to rotate the leadscrew 250 and to displace the growth stimulator (bone pins; supra) in relation to the bone of the subject (supra).
Claim 3 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Samchukov et al. (5,980,252; cited by Applicant).
Regarding claim 3, Samchukov et al. disclose a transport device (see annotated Fig. 2C, below) for increasing biological activity within a patient, comprising:
a base 20 (Figs. 1A, 1B, 2C) comprising a first end, a second end, an upper surface located between the first end and the second end, and a lower surface located between the first end and the second end (annotated Fig. 2C, below);
a base anchor (id.) configured to statically couple the base 20 to a first portion of a bone 50 of a subject (col. 8, line 51 - col. 9, line 9);
a translatable anchor (e.g., a screw; page 7, lines 60-67) configured to engage a growth stimulator 28;
a leadscrew 26 dynamically coupling the base 20 to the translatable anchor (screw; supra), wherein the leadscrew 26 is configured to rotate about a leadscrew axis while substantially maintaining its longitudinal position along the leadscrew axis in relation to the base 20, such that the growth stimulator 28, when engaged with the translatable anchor (screw; supra), is capable of independent movement in relation to the base 20 along a stimulation axis that includes at least some transverse displacement with respect to the bone 50 when the base 20 is coupled to the bone via the base anchor (col. 8, lines 28-38; and
a screw drive 24 (hex socket; Fig. 1B; col. 7, lines 52-59) rotatably coupled to the leadscrew 26 and configured to couple to a hex rotatable mating tool that is configured to rotate the leadscrew 26 via the screw drive 24 (id.).
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Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 27 of U.S. Patent No. 12,453,582.
Although the claims at issue are not identical, they are not patentably distinct from each other because the substantive difference between the application claims and the patent claims is that the patent claims include more elements and are more specific (additionally reciting “and coaxially” in each of claims 1 and 27 of the issued patent). Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Regarding independent application claim 1, claim 1 of the issued patent recites a system for increasing biological activity within a patient, comprising:
a housing;
a drive carried within the housing;
an indexing contour carried by the housing and configured to substantially stabilize the housing in relation to a transport device base of a transport device configured to move a growth stimulator in relation to a bone of a subject;
a locking portion configured to releasably lock the housing to the transport device base;
a rotatable mating tool carried by the housing, wherein the drive is configured to cause the rotatable mating tool to rotate, and wherein the rotatable mating tool is configured to be rotationally coupled to a screw drive of a leadscrew of the transport device when the housing is stabilized with the transport device base via the indexing contour and is locked to the transport device base via the locking portion; and
a control unit configured to output a control signal configured to direct the drive to rotate the rotatable mating tool.
Regarding independent application claim 2, claim 27 of the issued patent recites a method for increasing biological activity within a patient comprising:
providing a system comprising:
a housing;
a drive carried within the housing;
an indexing contour carried by the housing and configured to substantially stabilize the housing in relation to a transport device base of a transport device configured to move a growth stimulator in relation to a bone of a subject;
a locking portion configured to releasably lock the housing to the transport device base;
a rotatable mating tool carried by the housing, wherein the drive is configured to cause the rotatable mating tool to rotate, and wherein the rotatable mating tool is configured to be rotationally coupled to a screw drive of a leadscrew of the transport device when the housing is stabilized with the transport device base via the indexing contour and is locked to the transport device base via the locking portion; and
a control unit configured to output a control signal configured to direct the drive to rotate the rotatable mating tool;
surgically securing the transport device base to the bone of the subject;
surgically placing the growth stimulator within the patient and coupling the growth stimulator to the transport device base such that it is displaceable relative to the transport device base via rotation of the leadscrew;
engaging the indexing contour of the housing with the transport device base;
locking the housing to the transport device base via the locking portion;
coupling the rotatable mating tool to the screw drive of the leadscrew; and
initiating the control signal to cause the rotatable mating tool rotate the leadscrew and to displace the growth stimulator in relation to the bone of the subject.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of copending Application No. 19/162,038 (see U.S. Published Application Publication US 2026/0108276).
Although the claims at issue are not identical, they are not patentably distinct from each other because the substantive difference between the application claim and the patent claim is that the patent claim includes more elements and is more specific (e.g., additionally reciting the drive unit, the locking portion, and particulars thereof). Thus, the invention of the patent claim is in effect a “species” of the “generic” invention of the application claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claim is anticipated by the patent claim, it is not patentably distinct from the patent claim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claim has not in fact been patented.
Regarding independent application claim 3, claim 4 of the copending application (supra) recites a transport device for increasing biological activity within a patient, comprising:
a base comprising a first end, a second end, an upper surface located between the first end and the second end, and a lower surface located between the first end and the second end;
a base anchor configured to statically couple the base to a first portion of a bone of a subject;
a translatable anchor configured to engage a growth stimulator;
a leadscrew dynamically coupling the base to the translatable anchor, wherein the leadscrew is configured to rotate about a leadscrew axis while substantially maintaining its longitudinal position along the leadscrew axis in relation to the base, such that the growth stimulator, when engaged with the translatable anchor, is capable of independent movement in relation to the base along a stimulation axis that includes at least some transverse displacement with respect to the bone when the base is coupled to the bone via the base anchor; and
a screw drive rotatably coupled to the leadscrew and configured to couple to a rotatable mating tool that is configured to rotate the leadscrew via the screw drive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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