DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosures of the prior-filed applications, Application Nos. 17/807,921, 16/521,941, 15/699,711, 14/883,485, 14/250,313, 13/198,571, and 61/372,020, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. None of the prior-filed applications provide support for the claimed “at least two magnetic components” in claims 1, 8, and 11. According to the disclosure, magnetic assembly 236 includes a single cylindrical magnet 254 (see para. 0047; see also Fig. 5C) or two or more magnetically permeable components (see para. 0057). Magnetic components and magnetically permeable components are not interchangeable. Magnetic components retain a net magnetic field after an external field is removed. Magnetically permeable components are magnetized by an external field but do not retain a net magnetic field after the external field is removed. Thus, the prior-filed applications provide support for either (a) a magnetic assembly comprising a magnetic component or (b) a magnetic assembly comprising at least two magnetically permeable components but not (c) a magnetic assembly comprising at least two magnetic components. Furthermore, in situation (a), the maintenance member is a magnetically permeable component (see para. 0052), and in situation (b), the maintenance member is a magnet (see para. 0057). Thus, none of the prior-filed applications provide support for “at least two magnetic components” and “a maintenance member…comprising a magnet” (claim 1), “the magnetic assembly including two magnetic components” and “a first magnet attached to the adjustable portion” (claim 8), or “at least two magnetic component” and “a maintenance magnet” (claim 11).
Claim Objections
Claim 11 is objected to because of the following informalities: “component” should be “components” (line 3). Appropriate correction is required.
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 1-7 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. It is unclear how the implant of claim 1 would function due to the inclusion of the “at least two magnetic components” and the “maintenance member…comprising a magnet.” In order for the implant to properly function, one of the aforementioned must be magnetically permeable. The use of a magnetic component (such as, for example, cylindrical magnet 254) and a magnetically permeable component (in this example, maintenance member 303 being magnetically permeable) allow the implant to function properly because the magnetically permeable component strongly attracts either pole of the magnet but does not attract the portion between the poles (see para. 0052; see also Figs. 11A-11C, which illustrate this concept). As stated in the specification, such a relationship between the magnetic component and the magnetically permeable component is necessary in order to adjust the length of the adjustable implant (see para. 0053). The inclusion of at least three magnets without the inclusion of a magnetically permeable member would preclude adjustment of the length of the adjustable implant.
Claims 8-10 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. It is unclear how the system of claim 8 would function due to the inclusion of the “magnetic assembly including two magnetic components” and the “first magnet attached to the adjustable portion.” In order for the system to properly function, one of the aforementioned must be magnetically permeable. The use of a magnetic component (such as, for example, cylindrical magnet 254) and a magnetically permeable component (in this example, maintenance member 303 being magnetically permeable) allow the system to function properly because the magnetically permeable component strongly attracts either pole of the magnet but does not attract the portion between the poles (see para. 0052; see also Figs. 11A-11C, which illustrate this concept). As stated in the specification, such a relationship between the magnetic component and the magnetically permeable component is necessary in order to adjust the length of the system (see para. 0053). The inclusion of three magnets without the inclusion of a magnetically permeable member would preclude adjustment of the length of the system.
Claim 9 is 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 9 recites the limitations "the magnetic assembly" in line 1, “the adjustable portion” in line 1, and “the first magnet” in line 3. There is insufficient antecedent basis for these limitations in the claim. Because claim 8 includes such limitations, claim 9 is being interpreted as depending from claim 8.
Claim 10 is 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 10 recites the limitations "the first magnet" in line 1 and “the distraction system” in line 3. There is insufficient antecedent basis for these limitations in the claim. Because claim 8 includes such limitations, claim 10 is being interpreted as depending from claim 8.
Claims 11 and 12 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. It is unclear how the implant of claim 11 would function due to the inclusion of the “at least two magnetic components” and the “maintenance magnet.” In order for the implant to properly function, one of the aforementioned must be magnetically permeable. The use of a magnetic component (such as, for example, cylindrical magnet 254) and a magnetically permeable component (in this example, maintenance member 303 being magnetically permeable) allow the implant to function properly because the magnetically permeable component strongly attracts either pole of the magnet but does not attract the portion between the poles (see para. 0052; see also Figs. 11A-11C, which illustrate this concept). As stated in the specification, such a relationship between the magnetic component and the magnetically permeable component is necessary in order to adjust the length of the adjustable implant (see para. 0053). The inclusion of at least three magnets without the inclusion of a magnetically permeable member would preclude adjustment of the length of the adjustable implant.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 is not further limiting because it depends from a non-existent claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. For examination purposes, the Examiner is interpreting claim 12 as depending from claim 11.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 5, 8, 11, and 12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kim (US 2007/0179493 A1) in view of Conway (US 2009/0062798 A1).
Claim 1. Kim discloses an adjustable implant (implant 80) comprising:
a housing (center piece 90);
at least two magnetic components (magnets 94 and 98) disposed in the housing and configured to change a dimension of the adjustable implant; and
a maintenance member (upper magnet 82) attached to the housing (via upper end piece 81) and comprising a magnet (magnet 82) configured to attract at least one of the at least two magnetic components (Figs. 9 and 10; paras.0003 and 0062-0065).
Claim 5. Kim discloses wherein the magnet of the maintenance member is configured to attract a closest magnetic component (magnet 98) of the at least two magnetic components (Figs. 9 and 10; paras.0003 and 0062-0065).
Claim 8. Kim discloses a distraction system comprising:
a distraction rod (upper end piece 81) having a first end (end portion 86) configured for placement in a patient at a first location and a second end (end received in chamber 97) opposite the first end;
an adjustable portion (center piece 90) configured for placement in the patient at a second location and configured to engage the second end of the distraction rod, the adjustable portion comprising a housing (center piece 90), and a magnetic assembly (magnets 94 and 98) disposed within the housing;
the magnetic assembly including two magnetic components (magnets 94 and 98) configured to translate the distraction rod relative to the housing; and
a first magnet (upper magnet 82) attached to the adjustable portion (via upper end piece 81) and adapted to magnetically attract at least one of the two magnetic components (Figs. 9 and 10; paras.0003 and 0062-0065).
Claim 11. Kim discloses an adjustable implant comprising:
a housing (center piece 90 and end pieces 81);
at least two magnetic component (magnets 94 and 98) in the housing and configured to change a dimension of the adjustable implant; and
a maintenance magnet (upper magnet 82) rigidly attached to the housing, the maintenance magnet configured to attract at least one of the at least two magnetic components (Figs. 9 and 10; paras.0003 and 0062-0065).
Claim 12. Kim discloses wherein the maintenance magnet has an arcuate shape and is configured to maintain an amount of axial distraction in the adjustable implant by attracting at least one of the at least two magnetic components (Figs. 9 and 10; paras.0003 and 0062-0065).
Kim fails to disclose wherein the at least two magnetic components are configured to change the dimension of the adjustable implant upon a rotation of the at least two magnetic components about a longitudinal axis of the adjustable implant (claim 1), wherein the two magnetic components are configured to translate the distraction rod relative to the housing upon a rotation of the two magnetic components about a longitudinal axis of the adjustable portion (claim 8), and wherein the at least two magnetic component are configured to change the dimension of the adjustable implant upon a rotation of the at least two magnetic components about a longitudinal axis of the adjustable implant (claim 11).
Conway teaches an adjustable implant or distraction system (see “transport” in para. 0014, which comprises an internal rod and an external rod) wherein rotation of a magnetic component (see “magnetic material” in para. 0014) results in a change in the dimension of the implant/system (see para. 0014).
It would have been obvious to one of ordinary skill in the art at the time of the claimed invention to modify the implant/system of Kim such that the at least two magnetic components are configured to change the dimension of the adjustable implant upon a rotation of the at least two magnetic components about a longitudinal axis of the adjustable implant (claim 1), the two magnetic components are configured to translate the distraction rod relative to the housing upon a rotation of the two magnetic components about a longitudinal axis of the adjustable portion (claim 8), and the at least two magnetic component are configured to change the dimension of the adjustable implant upon a rotation of the at least two magnetic components about a longitudinal axis of the adjustable implant (claim 11), as suggested by Conway, as such is well-known in the art in order to change a dimension of an implant/system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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