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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: fixation elements in claims 1 and 3.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Samani, U.S. Patent 5,645,599.
Regarding claim 1, Samani discloses an implantable interspinous device comprising: a body (1) with a longitudinal anterior-posterior axis with a closed U-shaped anterior end (5a) and an open posterior end (5) and a superior arm and an inferior arm (both 6), wherein the superior and inferior arms are able to bend toward each other or away from each other (Fig. 1 and col. 3 line 66-col. 4 line 4); bone fixation elements (9) on either side of the body (via holes 8 in arms 6) (Figs. 1-2); and a removable extension restriction block (15) (Fig. 5 and col. 4 lines 44-51).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention 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 35 U.S.C. 103 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.
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samani, U.S. Patent 5,645,599 in view of Trieu, U.S. PG-Pub 2010/0222820.
Regarding claim 2, Samani discloses wherein the extension restriction block (15) can be inserted in a space (space between 5b) the superior and inferior arms (both 6) to limit extension or can be removed from the body to allow extension (Figs. 2 and 5 and col. 4 lines 44-51).
Samani does not explicitly disclose the extension restriction block prohibiting extension.
Trieu discloses an implantable device having an extension restriction block (50) inserted in a space (46) between superior and inferior arms (32, 34) to provide increasing, variable, constant and/or decreasing resistance and can be configured to prevent closing of an open end (40) (Figs. 1 and 3 and paragraph [0077]) to permit variable stiffness (paragraph [0014]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the extension restriction block of Samani to be configured for prohibiting extension in view of Trieu to permit the device provide or limit movement based on the needs of a specific patient.
Regarding claim 3, Samani discloses a method of performing an orthopedic surgical procedure comprising the steps of: implanting an interspinous device in between two successive interspinous processes (2) of a mammalian subject, wherein the interspinous device comprises a body (1) with a longitudinal anterior-posterior axis with a closed U-shaped anterior end (5a) and an open posterior end (5) and a superior arm and an inferior arm (both 6), wherein the superior and inferior arms are able to bend toward each other or away from each other (Figs. 1-2 and col. 3 line 66-col. 4 line 4), and further comprising bone fixation elements (9) on either side of the body (via holes 8 in arms 6); the interspinous device being dynamic allowing for extension of the successive spinous processes and inserting an extension restriction block (15) into the body to limit extension of the successive spinous processes (Fig. 5, col. 3 line 66-col. 4 line 4, and col. 4 lines 44-51).
Samani does not disclose determining the interspinous device is to be non-dynamic and the extension restriction block prohibiting extension.
Trieu discloses an implantable device having an extension restriction block (50) inserted in a space (46) between superior and inferior arms (32, 34) to provide increasing, variable, constant and/or decreasing resistance and can be configured to prevent closing of an open end (40) (Figs. 1 and 3 and paragraph [0077]) to permit variable stiffness (paragraph [0014]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the extension restriction block of Samani to be configured for prohibiting extension such that the interspinous device is non-dynamic in view of Trieu to permit the device provide or limit movement based on the needs of a specific patient.
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.
For the below non-statutory double patenting rejection, like elements will be bolded and additional elements will be non-bolded.
Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 8 of U.S. Patent No. 11,331,199. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 1 and 2 of the application, claim 3 of the patent recites “An interspinous posterior device, comprising: a body; and bone fixation elements on either side of the body, each of said bone fixation elements comprising a ratchet locking mechanism for fixing the body to successive spinous processes of a mammalian body, wherein each of the bone fixation elements is independently adjustable by ratcheting it separately and independently of the other bone fixation elements; wherein the body has a dynamic configuration and a non-dynamic configuration, wherein the dynamic configuration is configured to allow for both extension and flexion of successive spinous processes and the non-dynamic configuration configured to prohibit extension of successive spinous processes; a removable extension restriction block, wherein the extension restriction block can be inserted in the body to prohibit extension or can be removed from the body to allow extension; and wherein the body is a U-shaped implantable component having a longitudinal anterior-posterior axis with a closed rounded anterior end and an open posterior end and a superior arm and an inferior arm and a space in between the superior arm and the inferior arm that receives the removable extension restriction block, and wherein the U-shaped implantable component is non-dynamic when combined with the extension restriction block and is dynamic when not combined with the extension restriction block.”
It is clear that all the elements of claims 1 and 2 of the application are to be found in claim 3 of the patent. The difference between claims 1 and 2 of the application and claim 3 of the patent lies in the fact the patent claim includes more elements and is thus more specific. Thus the invention of claim 3 of the patent is in effect a “species” of the “generic” invention of claims 1 and 2 of the application. It has been held that the generic invention is “anticipated” by the “species.” See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 1 and 2 of the application are anticipated by claim 3 of the patent, they are not patentably distinct from claim 3 of the patent.
Regarding claims 1 and 2 of the application, claim 8 of the patent recites “An interspinous posterior device comprising: a U-shaped body that is implantable in between successive spinous processes, said U-shaped body having a longitudinal anterior-posterior axis with a closed rounded anterior end and an open posterior end and a superior arm and an inferior arm and a space in between the superior arm and the inferior arm capable of receiving a removable extension restriction block, and wherein the U-shaped body is non-dynamic upon receiving the extension restriction block and is dynamic when the extension restriction block is absent from the U-shaped body; a pair of opposing barrels extending in a superior direction from the superior arm, each of said barrels comprising one or more rows of ratchet slots or ratchet teeth; a pair of opposing barrels extending in an inferior direction from the inferior arm, each of said barrels comprising one or more rows of ratchet slots or ratchet teeth; four cylinders, each cylinder sized to fit within one of the barrels, each of said cylinders comprising one or more rows of ratchet teeth that mates with the one or more rows of ratchet slots or ratchet teeth of the barrels, wherein each cylinder has spikes on its medial end for engaging with bone of a spinous process and wherein the rows of ratchet teeth of the cylinders and rows of ratchet slots or teeth of the barrels form a ratchet locking mechanism that locks the cylinders with the barrels preventing movement of the cylinders in a lateral direction; and a removable extension restriction block that fits within the space between the inferior arm and superior arm of the U-shaped body, wherein the extension restriction block mates with the U-shaped body in a lateral movement restricted manner.
It is clear that all the elements of claims 1 and 2 of the application are to be found in claim 8 of the patent. The difference between claims 1 and 2 of the application and claim 8 of the patent lies in the fact the patent claim includes more elements and is thus more specific. Thus the invention of claim 8 of the patent is in effect a “species” of the “generic” invention of claims 1 and 2 of the application. It has been held that the generic invention is “anticipated” by the “species.” See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 1 and 2 of the application are anticipated by claim 8 of the patent, they are not patentably distinct from claim 3 of the patent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775
