DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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: actuation mechanism in claims 79 and 89.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 77-80, 83, 85-90, 93, 95 and 96 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Burkinshaw et al., U.S. PG-Pub 2004/0147932.
Regarding claim 77, Burkinshaw et al. discloses a method of forming a microfracture in subchondral bone of a patient, the method comprising: disposing a microfracture apparatus (110) adjacent to the subchondral bone, the microfracture apparatus comprising: a cannula (30) having a first end (40), a second end (42) and a channel (44) extending between the first end and the second end (Figs. 2, 6 and paragraph [0067]); a penetrator (34) having a proximal end (50), a distal end (52) including a pointed tip (65) with a cross-sectional shape defined by a tip angle (58) of 60 degrees or greater, and a first transverse dimension (dimension taken on the tip transverse to the longitudinal axis of the penetrator) (Figs. 2, 5 and paragraph [0049] discloses the cannula can have an angled tip 84 of 60 degrees; wherein it is understood, that when penetrator 34 is placed within the cannula, tip angle 58 of the penetrator conforms with the cannula angle, thus making the tip angle 60 degrees; furthermore, various tip angles of greater than 60 degrees are also disclosed, i.e. 90 degrees);
disposing the penetrator (34) in the channel of the cannula (30) such that the penetrator is movable between a retracted position and an extended position in which the distal end (52) extends beyond the second end (42) of the cannula; and advancing the penetrator relative to the cannula, substantially without rotation of the penetrator, until the distal end of the penetrator extends into the subchondral bone to form a microfracture having a penetration distance greater than the first transverse dimension of the penetrator (Fig. 6 and paragraph [0068]).
Regarding claims 78-80, Burkinshaw et al. further comprises retracting the penetrator from the subchondral bone; wherein said retracting is via an actuation mechanism (via release of 107); and further comprises repeating the disposing, advancing and retracting at different locations adjacent to the subchondral bone so as to form a plurality of microstructures in the subchondral bone (Fig. 6 and paragraphs [0052], [0068]-[0069]).
Regarding claims 83, 85 and 86, Burkinshaw et al. discloses wherein the penetrator (34) comprises a primary portion (56) having a second transverse dimension greater than the first transverse dimension (dimension taken on the tip transverse to the longitudinal axis of the penetrator); wherein the microfracture apparatus (110) further comprises an enlarged head (56) coupled to the proximal end (50) of the penetrator (Fig. 2); and wherein a penetrator removal tab (107) is coupled to the penetrator, the penetrator removal tab configured to retract the penetrator (via release of 107) relative to the cannula (30) (Fig. 6 and paragraphs [0068]-[0069]).
Regarding claim 87, Burkinshaw et al. discloses a method of forming a microfracture in subchondral bone of a patient, the method comprising: disposing a microfracture apparatus (110) adjacent to the subchondral bone, the microfracture apparatus comprising: a cannula (30) having a first end (40), a second end (42), and a channel (44) extending between the first end and the second end, the cannula having a primary portion (portion between 46 and 48) and a distal portion (portion between 48 and end 44) between the primary portion and the second end, and a curve (48) between the primary portion and the distal portion such that the distal portion is disposed at a nonparallel angle relative to the primary portion; and a penetrator (34) having a proximal end (50), a distal end (52), and a first transverse dimension (dimension taken on the tip 65 transverse to the longitudinal axis of the penetrator) (Figs. 2, 6 and paragraph [0068]);
disposing the penetrator (34) in the channel of the cannula (30) such that the penetrator is movable between a retracted position and an extended position in which the distal end (52) extends beyond the second end (42) of the cannula by a penetration distance greater than the first transverse dimension (distal end 52 extends beyond second end 42 by a distance that is greater than the width of 65, i.e. first transverse dimension); advancing the penetrator from the retracted position to the extended position substantially without rotation of the penetrator to form in subchondral bone a microfracture; and where a portion of the penetrator is configured to flex around the curve (48) in the cannula as the penetrator moves between the retracted and extended positions (Figs. 2, 6 and paragraphs [0046], [0068]-[0069]).
Regarding claims 88-90, Burkinshaw et al. further comprises retracting the penetrator from the subchondral bone; wherein said retracting is via an actuation mechanism (via release of 107); and further comprises repeating the disposing, advancing and retracting at different locations adjacent to the subchondral bone so as to form a plurality of microstructures in the subchondral bone (Fig. 6 and paragraphs [0052], [0068]-[0069]).
Regarding claims 93, 95 and 96, Burkinshaw et al. discloses wherein the penetrator (34) comprises a primary portion (56) having a second transverse dimension greater than the first transverse dimension (dimension taken on the tip 65 transverse to the longitudinal axis of the penetrator); wherein the microfracture apparatus (110) further comprises an enlarged head (56) coupled to the proximal end (50) of the penetrator (Fig. 2); and wherein a penetrator removal tab (107) is coupled to the penetrator, the penetrator removal tab configured to retract the penetrator (via release of 107) relative to the cannula (30) (Fig. 6 and paragraphs [0068]-[0069]).
Claim Rejections - 35 USC § 103
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.
Claims 81 and 91 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Burkinshaw et al., U.S. PG-Pub 2004/0147932 in view of Miller, U.S. PG-Pub 2009/0274996.
Regarding claims 81 and 91, Burkinshaw et al. discloses the invention essentially as claimed except for wherein the first transverse dimension of the penetrator is less than 1.2 millimeters (mm).
Miller et al. discloses a bone penetration device (30) having an outer diameter (transverse dimension) approximately 1 mm to prevent excess loss of bone (paragraph [0022]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the first transverse dimension of the penetrator of Burkinshaw et al. to be less than 1.2 mm in view of Miller et al. to permit prevention of excess loss of bone.
Claims 82 and 92 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Burkinshaw et al., U.S. PG-Pub 2004/0147932.
Regarding claims 82 and 92, Burkinshaw et al. discloses the invention essentially as claimed except for wherein the penetration distance is at least 5 times greater than the first transverse dimension of the penetrator.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the penetration distance to be at least 5 times greater than the first transverse dimension of the penetrator, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Furthermore, the unexpected results would have been readily foreseen without undo experimentation, namely, ensuring the penetration distance suits the particular needs of a specific patient.
Claims 84 and 94 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Burkinshaw et al., U.S. PG-Pub 2004/0147932 in view of Assell et al., U.S. PG-Pub 2008/0071282.
Regarding claims 84 and 94, Burkinshaw et al. discloses the invention essentially as claimed except for wherein a coating is disposed on at least a penetration portion of the penetrator.
Assell et al. discloses an apparatus coated with a hydrophilic coating to facilitate passage of other surgical tool and/or implants (paragraph [0217]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the penetration portion of the penetrator of Burkinshaw et al. to have a hydrophilic coating in view of Assell et al. to permit easier insertion of the penetrator within the cannula.
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 77-81 and 86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16, 17, 19 and 20 of U.S. Patent No. 11,376,019 in view of Burkinshaw et al., U.S. PG-Pub 2004/0147932.
Regarding claims 77-81 and 86, claims 16, 17 19 and 20 of U.S. Patent No. 11,376,019 recite the claimed invention except for wherein the penetrator has a tip angle of 60 degrees or greater.
Burkinshaw et al. discloses a penetrator (34) having a tip angle (via bend 58) that is 60 degrees (Figs. 2, 5 and paragraph [0049] discloses the cannula can have an angled tip 84 of 60 degrees; wherein it is understood, that when penetrator 34 is placed within the cannula, tip angle 58 of the penetrator conforms with the cannula angle, thus making the tip angle 60 degrees, and can have tip angles of various degrees greater than 60 degrees, i.e. 90 degrees).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify claims 16, 17, 19 and 20 of U.S. Patent No. 11,376,019 such that the penetrator has a tip angle of 60 degrees or greater in view of Burkinshaw et al. to permit easier placement of the penetrator within various joint placements or sizes based on the patient.
Claims 87-91 and 93-95 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-15 of U.S. Patent No. 12,161,347 in view of Burkinshaw et al., U.S. PG-Pub 2004/0147932.
Regarding claims 87-91 and 93-95, claims 9-15 of U.S. Patent No. 12,161,347 recite the claimed invention except for wherein a portion of the penetrator is configured to flex around the curve in the cannula as the penetrator moves between the retracted and extended positions.
Burkinshaw et al. discloses a flexible penetrator (34) that is configured to flex around a curve (48) in a cannula (30) as the penetrator moves between retracted and extended positions (Figs. 2, 6 and paragraphs [0046], [0068]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the penetrator of claims 9-15 of U.S. Patent No. 12,161,347 to be flexible such that the penetrator is configured to flex around the curve in the cannula as the penetrator moves between retracted and extended positions in view of Burkinshaw et al. to permit optimal movement of the penetrator within the cannula to help ensure a desired angle is possible for accurate placement within a joint of a patient.
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).
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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775
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