DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Invention I and Species A in the reply filed on 01/05/20 is acknowledged.
Claims 1-20 are pending. Claims 12-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
Claims 1-11 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.
In claim 1, the limitations of “providing a bone growth distraction device,” “providing an external adjust device,” and “operating the external adjustment device” are indefinite because it is unclear what action, if any, is required by the claimed method.
Regarding the step of “providing a bone growth distraction device,” this limitation is indefinite between the term “providing” does not indicate what action is required. It is unclear whether this step requires manufacturing the device, purchasing the device, obtaining the device from another source, surgically implanting the device, merely having the device available, or some other action entirely. The scope of the claimed method is therefore uncertain.
Regarding the step of “providing an external adjustment device,” this limitation suffers form the same deficiency. The claim does not specify whether the method requires creating, acquiring, receiving, or simply possessing the external adjustment device. Additionally, it is unclear whether the performer of the claimed method must provide this device, or whether it is provided by another party.
The providing steps do not clearly establish whether they constitute actual method steps with patentable weight or merely recite the starting materials/apparatus required before the method begins. If these steps merely describe obtaining pre-existing components, they do not constitute transformative process steps.
Regarding the step of “operating the external adjustment device,” the relationship between this step and the prior “providing” steps is unclear due to the ambiguity of what “providing” entails.
One skilled in the art cannot determine with reasonable certainty the metes and bounds of the claimed invention. This rejection can be overcome by clarifying the “providing” steps – e.g., “surgically implanting a bone growth distraction device.”
In claim 11, “an implanted medical device,” and “the implanted medical device” should be changed to --the bone growth distraction device--.
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 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 11 of U.S. Patent No. 11,974,782 B2 in view of Hildebrandt et al. (U.S. 3,976,060) and Blunn et al. (U.S. 2004/0030395 A1).
Regarding claim 1, the patent discloses every element except for reciting the step of providing a bone growth distraction device configured to be attached to bone having a proximal portion and a distal portion by a proximal securement member and a distal securement member; wherein the bone growth distraction device includes a magnetic assembly that includes a cylindrical magnet that is configured to rotate on its axis in response to an externally applied magnetic field, and operating the external adjustment device to cause rotation of the cylindrical magnet of the bone growth distraction device.
Hildebrandt et al. disclose a method of stabilizing bone comprising the steps of providing a bone growth distraction device (see Figs. 7 and 8) configured to be attached to bone having a proximal portion and a distal portion by a proximal securement member (see Fig. 1, element 14) and a distal securement member (see Fig. 1, element 15 and see col. 3, lines 40-43); wherein the bone growth distraction device includes a magnetic assembly (see Fig. 7, element 86) that includes a magnet that responds to an externally applied magnetic field, and operating an external adjustment device (see Fig. 7, element 86d) to move the bone growth distraction device.
Blunn et al. teach a cylindrical magnet (see Fig. 2, element 8) that when rotated causes elongation of a bone growth distraction device in the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include and modify a bone growth distraction device having a magnetic assembly, and to operate the external adjustment device to move the bone growth distraction device by rotating internal magnets, the concepts of which are disclosed by Hildebrandt et al. and Blunn et al., in order to provide a magnetically-controlled implantable device that uses externally-applied rotating magnetic fields to drive internal mechanisms in a non-invasive manner. One of ordinary skill would have been motivated to combine these teachings to achieve the predictable result of non-invasive, controlled bone distraction with reduced infection risk and improved patient outcomes.
Concerning claim 2, see claim 2 of the patent.
Concerning claim 3, it would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the magnet as having a first magnet for rotation about a first axis and a second magnet for rotation about a second axis, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Concerning claim 4, see claim 11.
Concerning claim 5, see claim 3.
Concerning claim 6, see claim 4.
Concerning claim 7, see claim 5.
Concerning claim 8, see claim 6.
Concerning claim 9, see claim 7.
Concerning claim 10, see claim 8.
Concerning claim 11, see claim 9.
Allowable Subject Matter
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the bone growth distraction device and the external adjustment device as recited in claim 1. Pool (U.S. 2008/0097487 A1) discloses the closest prior art to the external adjustment device but does not disclose a microcontroller configured to communicate with at least one of the at least one magnet, the drive system, or the at least on bidirectional control and thereby to cause the changing magnetic field to change, wherein the microcontroller is also configured to prevent change of the changing magnetic field in response to one or more pre-determined criteria being met.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The art relates to implantable distraction devices and devices to expand or contract the devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at 571 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773