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 .
Election/Restrictions
Applicant’s election without traverse of species 5 in the reply filed on 12/1/2025 is acknowledged.
Claims 7-36, 46 and 47 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/1/2025.
Claim Objections
Claims 43 and 49 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in alternative only. See MPEP § 608.01(n). Accordingly, the claims 43 and 49 have not been further treated on the merits.
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 3, 4, 37-45 and 48-55 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.
Claim 3 claims “a distraction force deficit” in lines 5-6 claim 1 already claims “a distraction force deficit” it is unclear if claim 3 is introducing a second “force deficit” and claim 3 should read “the distraction force deficit.”
Claim 4 recites the limitation "the inner circumference… the outer circumference" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 37 claims “an active distraction force” in line 36 and already claims “an active distraction force” in line 17. It is unclear if these are different forces, line 36 should read “the active distraction force.”
Claim 37 also recites the limitation "the stimulus" in line 35. There is insufficient antecedent basis for this limitation in the claim. Claim 37 should read “a stimulus”
Claim 38 states “at least one thrust bearing” claim 37 already claims “at least one thrush bearing” making it unclear if claim 38 is requiring additionally bearings. Claim 38 should read “the at least one thrush bearing.”
Claim 39 recites the limitation "the deformity site" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 40 recites the limitation "the second static segment" in line 5. There is insufficient antecedent basis for this limitation in the claim. Claim 40 should depend from claim 38.
Claim 42 recites the limitation "the deformity site" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 45 recites the limitation "the second growth segment" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 45 should depend from claim 41.
Claim 48 recites the limitation "said first intermediate segment" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 48 should depend from claim 40.
Claim 48 also recites the limitation "the external circumference… the internal circumference" in lines 4 and 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 54 recites the limitation "the body" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-6, 37-45 and 48-55 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claims 1, in line 10 and claim 37 in line 29 claim “during the natural growth of the deformed bony anatomy” positively claiming the body. The claims should include wherein the system is “configured to” or “capable of” to not claim the body.
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.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dahlgren et al. (US Pub 2009/0076597).
With respect to claim 1, Dahlgren discloses a constant distraction force driven self-actuating growing rod system (see figures 1-2 below) for implantation on a deformed bony anatomy; said system (100) comprising: a. at least one static rod component (fig 1, 3 left); b. at least one intermediate rod component (fig 1, 13); c. at least one growth rod component (fig 1, 3 right and 2); d. at least one compression spring component (fig 1, 46) adapted to apply an active distraction force onto the system; e. at least one magnetic field-based spring actuation mechanism (abstract and fig 1, 4a, 4b); and f. at least one dynamic sealing plug (fig 1, 5), wherein during the natural growth of the deformed bony anatomy, the growth rod component telescopes out of the intermediate rod component, creating a distraction force deficit in the system; said distraction force deficit being corrected by causing at least one part of the compression spring component to compress by means of said magnetic field-based spring actuation mechanism (paragraph 18, external magnetic field); thereby maintaining an active distraction force onto the system (paragraph 18 spring keeps the system under tension). With respect to claim 2, Dahlgren discloses wherein said compression spring component is at least one selected from the group consisting of a helical coil spring (fig 1 shows a helical spring), a conical coil spring, a leaf spring, a constant force spring, a disc spring, a constant rate spring, an extension coil spring and a constant torque spring. With respect to claim 3, Dahlgren discloses wherein a part of said compression spring component is installed in a pre-compressed state (paragraph 18 spring is in compression) and during the natural growth of the deformed bony anatomy, the telescoping movement of the growth rod component causes said pre-compressed part of the compression spring component to relax (in figure 1B when 3 is pulled out the spring becomes less compressed relaxing it); thereby creating a distraction force deficit in the system. With respect to claim 4, Dahlgren discloses wherein said dynamic sealing plug is affixed between the inner circumference of a first intermediate segment (cylindrical portion near the right end of the intermediate component) of the intermediate rod component and the outer circumference of a second growth segment (fig 1A, 2) of the growth rod component and is adapted to prevent movement of at least one contaminant (paragraph 18, prevent tissue from entering) in and out of the system (fig 1A the plug is shown between the intermediate segment and the second growth segment). With respect to claim 5, Dahlgren discloses comprising at least one anti-rotation feature selected from the group consisting of gears, splines, keys and ratchet (See fig 2A below). With respect to claim 6, Dahlgren discloses being adapted for the correction of orthopaedic deformities (fig 8).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 12121265 B2, US 11737787 B1, US 10456172 B2, US 9333009 B2, US 20150134008, US 8734488 B2, US 8974463 B2 discloses a growing rod but does not disclose a spring to maintain a constant distraction force or a mechanism to maintain an active distraction
US 11039859 B2, US 10363069 B2 disclose a growing rod but does not disclose a magnetic actuation mechanism to maintain an active distraction force
US 8632544 B2, US 8043299 B2, US 7063706 B2, US 4931055 A disclose a distraction device but does not disclose maintaining an active distraction force an active distraction force
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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773