DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
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Claims 151-160 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of related U.S. Patent No. 11,351,040 in view of Hedley et al. (US PG Pub. No. 2005/0038443).
Claim 1 of the patent recites a method of treating a hip joint of a human patient, the hip joint comprising an acetabulum, the acetabulum being a part of the pelvic bone, and a caput femur, the caput femur being the proximal part of the femoral bone, said method comprising the steps of: cutting the skin of the human patient, dissecting an area of the pelvic bone on an abdominal side of the pelvic bone, creating a hole in said dissected area, said hole passing through the pelvic bone from the abdominal side and into the hip joint of the human patient, and further comprising at least one of the steps selected from the group consisting of: placing or fixating fixation elements to the pelvic bone or to a prosthetic part in the hip joint, fixating an artificial hip joint surface, or a part of an artificial hip joint surface, to the pelvic bone or the femoral bone, connecting at least two prosthetic parts to each other after insertion into the hip joint, and introducing a prosthesis into the hip joint, wherein said at least one step is conducted through said hole in the pelvic bone.
Claim 1 fails to disclose introducing a surgical instrument in the abdomen, and bending a portion of a longitudinal extension of said surgical instrument.
Hedley et al. discloses a surgical tool for use in hip replacement surgeries (300, Figs. 3-6B, Paragraphs [0023-0030]), the surgical tool comprising a handle (322) and a shaft portion (Fig. 3) extending between a bit end (310) and a drive end (315), wherein the bit end supports a head (320) that rotates with respect to a conduit (305) of the shaft portion, wherein the head mates with an acetabular reamer cup (100, Fig. 1), wherein the shaft portion comprises a flexible shaft which extends through the conduit (Fig. 4) so that the rotating shaft end (330) rotates the head (320), and wherein “Conduit 305 includes a pair of bends 340 and 345, so a portion of conduit 305 extends along a third axis 350 at an angle 355 with respect to first rotational axis 325 and an angle 360 with respect to second rotational axis 335. Angles 355 and 360 are equal in the depicted embodiment, though this need not be the case. The double bend of tool 300 avoids soft tissue for improved visibility and positional accuracy, but still provides a straight-line approach to tool placement. In embodiments in which rotational axes 325 and 335 are parallel, the operator enjoys a correct sense of the position of bit end 310 even when blood and tissue obstruct direct viewing. [0025] The inclusion of bends 340 and 345 facilitates ease of access, but renders difficult the task of transmitting high torque through conduit 305. Some embodiments employ a flexible shaft to convey torque from shaft end 330 to head 320, but such embodiments sometimes suffer gripping and vibration when actuating an acetabular reamer cup against hard or uneven bone surfaces.” (Paragraph [0024])
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the patent to include the step of introducing a surgical instrument in the abdomen and bending a portion of a longitudinal extension of said surgical instrument as taught by Hedley et al. as a well-known and common step done during a hip replacement which allows an acetabulum to be reamed precisely prior to implanting prosthetics into the hip joint.
As to Claims 152-160 of the application: The limitations of Claims 152-153 & 155-160 are found in Claim 1 of the patent and the limitations of Claims 154 are found in Claim 2 of the patent.
Claim Objections
Claim 151 is objected to because of the following informalities and should be amended as follows:
“151. (New) A method of treating a hip joint of a human patient, the hip joint comprising an acetabulum, the acetabulum being a part of [[the] a pelvic bone, and a caput femur, the caput femur being [[the] a proximal part of [[the] a femoral bone, said method comprising the steps of: cutting the skin of the human patient, dissecting an area of the pelvic bone on an abdominal side of the pelvic bone, creating a hole in said dissected area, said hole passing through the pelvic bone from the abdominal side and into the hip joint of the human patient, introducing a surgical instrument in the abdomen, and bending a portion of a longitudinal extension of said surgical instrument.” Appropriate correction is required.
Claim 152 is objected to because of the following informalities: In Line 1, a comma should be added immediately following the number “151”. Appropriate correction is required.
Claim 154 is objected to because of the following informalities and should be amended as follows:
“154. (New) The method according to claim 153, wherein the step of placing or fixating the fixation element to the pelvic bone or a prosthetic part in the hip region or the pelvic bone region comprises the acetabulum of said human patient, wherein the surgical instrument is adapted to introduce a prosthesis through the hole in the pelvic bone and into the hip joint,
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 153-160 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 153 at Lines 2-3 recites the limitations “the hip region” and “the pelvic bone region”. Claim 154 further recites both terms in multiple instances. There is insufficient antecedent basis for these limitations in Claim 153 and it is unclear if the recited hip region is the previously recited hip joint itself or an area in another place in the hip or a region nearby, and further unclear if the recited pelvic bone region is the previously recited pelvic bone itself or another area of the pelvic bone or a region nearby. For purposes of examination, the limitations in Claim 153 are being interpreted as “a hip region” and “a pelvic bone region”. Appropriate correction is required.
Claim 154 at Lines 6-7 recites the limitation “wherein said surgical instrument is further adapted to operate through a surgically created hole in the pelvic bone on the opposite side of acetabulum” which renders the claim indefinite as it is unclear if the recited “surgically created hole in the pelvic bone” is the same hole in the pelvic bone as the previously recited ‘hole passing through the pelvic bone’ in Line 7 of independent Claim 1 or a different/additional one. For purposes of examination, the limitation is being interpreted as “wherein said surgical instrument is further adapted to operate through the hole passing through [[in]] the pelvic bone
Claim 154 at Line 12 recites the limitation “to place or fixate fixating elements to the pelvic bone” which renders the claim indefinite as it is unclear if the recited fixating elements are the same as (or a plurality of) the previously recited fixation element previously recited in Claim 153 from which Claim 154 depends, or a different set of fixating elements all together. For purposes of examination, the “fixating elements” are being interpreted as being the “fixation element” of Claim 153 and it is suggested that the last two lines of the claim be deleted as they are redundant under this interpretation. Appropriate correction is required.
Claim 155 at Lines 1-2 recites the limitation “wherein the step of performing an action in the hip joint” which renders the claim indefinite as there is insufficient antecedent basis for “the step of performing an action in the hip joint” and it is unclear if another step is being recited by the limitation “performing a surgical action” or if the antecedent basis needs to be fixed. Furthermore, the specification does not recite a specific type of “action” and thus this step is indefinite. Appropriate correction is required.
Claim 157 at Lines 1-2 recites the limitation “wherein the step of performing an action in the hip joint” which renders the claim indefinite as there is insufficient antecedent basis for “the step of performing an action in the hip joint” and it is unclear if another step is being recited by the limitation “performing a surgical action” or if the antecedent basis needs to be fixed. Furthermore, the specification does not recite a specific type of “action” and thus this step is indefinite. Appropriate correction is required.
Claim 159 at Lines 1-2 recites the limitation “wherein the step of performing an action in the hip joint” which renders the claim indefinite as there is insufficient antecedent basis for “the step of performing an action in the hip joint” and it is unclear if another step is being recited by the limitation “performing a surgical action” or if the antecedent basis needs to be fixed. Furthermore, the specification does not recite a specific type of “action” and thus this step is indefinite. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 156, 158 & 160 are 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 156 recites “156. (New) The method according to claim 155, wherein the step of fixating an artificial hip joint surface, or a part of an artificial hip joint surface, to the pelvic bone or the femoral bone comprises the step of fixating an artificial hip joint surface, or a part of an artificial hip joint surface, to the pelvic bone or the femoral bone.” This claim fails to further limit Claim 155 from which it depends since Claim 155 previously recites this step.
Claim 158 recites “158. (New) The method according to claim 157, wherein the step of connecting at least two prosthetic parts to each other after insertion into the hip joint comprises the step of connecting at least two prosthetic parts to each other after insertion into the hip joint.” This claim fails to further limit Claim 157 from which it depends since Claim 157 previously recites this step.
Claim 160 recites “160. (New) The method according to claim 159, wherein the step of introducing a prosthesis through the hole in the pelvic bone and into the hip joint comprises the step of introducing a prosthesis through the hole in the pelvic bone and into the hip joint.” This claim fails to further limit Claim 159 from which it depends since Claim 159 previously recites this step.
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.
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.
Claims 151-160 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shah (U.S. Patent No. 6,010,535) in view of "Modification of the anterior iliofemoral approach to the hip" by Schaubel (International Surgery publication, Jul-Aug 1980, National Center for Biotechnology Information, U.S. National Library of Medicine, http://www.ncbi.nlm.nih.gov/pubmed/7014496) and Kashuba (WIPO Pub No. WO 94/27507).
Regarding Claims 151, 152 & 153-160 as best understood, Shah discloses a method of treating a hip joint (12, 18, 20, Fig. 1) of a human patient, said hip joint comprising an acetabulum (18) which is part of a pelvic bone (14) and a caput femur (20) which is a proximal part of a femoral bone (16), said method comprising the steps of: cutting the skin of the human patient (Col. 9, Lines 58-60), creating a hole into the hip joint of the human patient (Fig. 1), drilling a hole through the femoral head, and drilling a hole into the hip joint through the greater trochanter (Fig. 2) and through the acetabulum (Figs. 1-2), inserting a guidewire (44) through the hole through the greater trochanter and the acetabulum, inserting a surgical instrument (reaming device) over the guide wire and forming a bore (42) extending therealong, wherein a cup prosthesis (22) is then inserted through the bore and installed in the hip joint adjacent the acetabulum (Fig. 1) and a shaft (30) and associated ball member prosthesis (28) are inserted through the bore and installed in the caput femur (Col. 7, Lines 41-67), and wherein surgical screws (34 & 36) are then inserted into the pelvic bone adjacent the cup prosthesis (Fig. 1) to threadedly engage the cup prosthesis (Col. 6, Lines 54-66) by rotating the ends of the screws by known surgical techniques, and wherein a surgical nail (38) is installed extending through the greater trochanter (32) and into the hip joint to engage the shaft of the associated ball member and the distal end of the nail is then secured by surgical screws (41 & 43) inserted into and through the femur and trapped by the nail (Fig. 1, Col. 6, Line 66 – Col. 7, Line 8), wherein the shaft (30) and ball member prosthesis (28) inserted through the caput femur is then pushed such that the ball member (28) engages an interior cavity (24) of the cup member (22) to fully assemble the hip joint prosthesis components together and surgical closure of the incisions and surgical openings is then carried out in a known manner (Col. 7, Lines 30-67).
Shah does not positively disclose dissecting an area of the pelvic bone on an abdominal side of the pelvic bone, creating a hole in said dissected area, said hole passing through the pelvic bone from the abdominal side and into the hip joint of the human patient.
Schaubel discloses an iliofemoral surgical approach to the hip joint, comprising dissecting an area of the pelvic bone on an abdominal side of the pelvic bone ("the iliac crest is osteotomized and dissected distally with the fascia lata to expose the hip capsule. Abstract) (Examiner notes that the greater pelvis is considered a portion of the abdominal cavity), and creating a hole in said dissected area, said hole passing through the pelvic bone and into the hip joint of the human patient (Abstract).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method of Shah with the steps of dissecting an area of the pelvic bone on an abdominal side of the pelvic bone, and creating the hole in the acetabulum and caput femur via the dissected area such that it passes through the pelvic bone into the hip joint as taught by Schaubel in order to provide a method that allows for a direct approach to the hip joint with the benefit of early functional return of the patient and minimized blood loss.
Shah further fails to disclose bending a portion of a longitudinal extension of said surgical instrument.
Kashuba discloses a cannulated reaming apparatus (10, Figs. 1-4) used in hip surgery including a cannulated flexible shaft (12) and reamer (14) with a cutting head (18) at a distal end thereof, wherein the reaming apparatus is configured to be inserted over a guide wire (59) inserted prior to insertion of the shaft of the reaming apparatus and used initially to locate and guide the cutting head and flexible shaft within a canal through a bone to shape the canal to match an implant shape to be subsequently implanted in the bone (Pages 7-9). Kashuba teaches using the flexible shaft for the purpose of providing control and allowing the reamer to be angled as needed in a controlled manner to shape the bone to fit the prosthesis.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the surgical tool/reaming device used in the method of Shah to include a flexible shaft used over the guide wire as taught by Kashuba so that a surgeon has more control and allows the tool/device to be angled in a controlled manner during shaping of the bone canal for subsequent placement of the prosthesis.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. 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.
/JESSICA WEISS/Primary Examiner, Art Unit 3775