DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application claims priority from application 11/743,097, filed 05/01/07
Status of Claims
Claims 45-56 and 58 are pending.
Claims 46-47 have been withdrawn from consideration.
Claims 1-44 and 57 have been cancelled.
Election/Restrictions
Applicant’s election without traverse of Species 62 (Figures 92-94) in the reply filed on 03/14/2025 is acknowledged.
Upon further review claims 46 and 47 have been withdrawn as being directed at non-elected embodiments. Paragraphs [0233]-[0236] describe the elected embodiment. Specifically, [0234] describes sleave element 494 as an energy absorber that bends like a spring, this bending is absorbing forces when in flexion and the inner spring 496 absorbs forces when compressed in extension. Therefore the offloading occurs at both flexion and extension, which is contradictory to claims 46 and 47. Similarly the outer lower sleave in combination with its lower spring perform in the same manner, the flexing and bending off load some forces during flexion and the inner spring offloads forces in extension. Therefore the energy absorber of the elected embodiment is not consistent with the recitations of claims 46 and 47 requiring them to be withdrawn.
Specification
The objection to the abstract has been withdrawn in view of the applicant’s amendments.
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke § 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke § 112(f) except as otherwise indicated in an Office action.
Claim Objections
The claim objections have been withdrawn in view of the applicant’s amendments.
Claim Rejections - 35 USC § 112
The 112 claim rejections have been withdrawn in view of the applicant’s amendments.
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 45, 48-56, and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Orsak et al (Orsak) USPN 6,162,223 in view of Paul et al (Paul) WO 2004/105577 A2
Orsak discloses the invention substantially as claimed being a medical system for manipulating energy transferred by members defining a knee joint (Figures 11-15).
The members (upper and lower bones shown in Figures 11-12) collectively defining a path of motion associated with a normal gait for a patient between extension and flexion prior to an onset of joint disease (this is true for every natural knee) and the system being attached to the members of the knee joint of the patient (claims of Figure 5 are used to attach the system to the knee depicted in Figures 11-15) while preserving the normal gait of the patient that is associated with the knee joint of the patient prior to the onset of a joint disease affecting the knee joint of the patient and the attachment of the system to the members of the knee joint of the patient (5:64-66).
However, it is unclear if the system of Orsak absorbs energy because of the two inner shafts 15/16.
Paul teaches the use of an energy absorbing system (Figures 12-12A) which acts as a shock absorber in the same field of endeavor for the purpose of offloading forces from the members and cartilage of a knee.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to replace the connecting system of Orsak with the energy absorbing system of Paul in order to maintain the full range of motion while offloading forces from the cartilage and other members of the knee.
45. Orsak as modified discloses a system for manipulating energy transferred by members defining a knee joint (both abstracts), comprising:
a first attachment structure configured to be attached to a first member of the joint; a second attachment structure configured to be attached to a second member of the joint (Orsak discloses all of his systems are attached to a pair of clamps that secure it to bone above and below the flexible element Figures 1 and 5); and
Paul discloses the energy absorption assembly (100 Figure 12A) attached to the first attachment structure and the second attachment structure (the fasteners go through the ends of rods 102 to attach to the bone); wherein the energy absorption assembly is configured to off-load the joint and to one or more improve alignment, stability or support of the joint or enhanced ligament function of the joint (the spring and rods of energy absorbing assembly absorb forces and bias the joint to offload forces from and stabilize the joint).
48. Paul discloses the energy absorption assembly is configured to be implanted adjunctive to medical treatments of the joint (this claim is considered to be extremely broad because there are an infinite number of “medical treatments” that could be done, for example: expanding/distracting the joint, application of drugs, removal of diseased or damaged materials, visual inspection, etc. All of which are capable of being done and routinely done with just about every medical implant. In this case the implant of Paul is fully capable of being implanted while the joint undergoes the medical treatment of delivering drugs in order to aid in the healing process)).
49. In regards to the requirement for the assembly to enable the joint to go through less restrictive rehabilitation regime than a knee without the assembly, it is noted that the required final outcome is not described within the claim. The amount and severity of rehabilitation can be determined by numerous factors outside of the implant such as patient condition, insurance, patient’s desired outcome, and access to medical care. Therefore a patient with less access to medical support or is old with limited mobility, they are able to receive more or less care based on their desires. Accordingly all implants are capable of enabling the patient to go through less restrictive rehabilitation than if they had no surgery done on the implant (i.e. the untreated knee may not allow for any rehabilitation).
50. 51. 52. Paul discloses the energy absorption assembly is configured to protect native or non-native cartilage including hyaline cartilage and fibrocartilage (the implant of Paul is capable of being inserted adjacent any joint and offloading forces that the joint experiences, therefore it is inherently capable of protecting any of the cartilage within the body)
53. Paul discloses the first and second members of the joint are in an extension configuration, off-loading and energy manipulation is at its greatest (when the spring of Paul’s energy absorbing member is straight as in extension, it is capable of offloading the maximum amount of energy because it allows for the greatest degree of compression Figure 12A).
54. Ozark as modified by Paul discloses the system transfers energy that cartilage experiences during the normal gait to bone outside the knee joint (by attaching the system of Paul around a joint it acts as a spring that compresses and flexes which will inherently absorb at least some of the natural forces exhibited throughout the gate).
55. In regards to the joint being is a knee joint affected with osteoarthritis, this is considered intended use and given limited weight, the system of Paul is a single elongated absorbing member attached with fasteners at the top and bottom which would allow it to be inserted adjacent the knee regardless of the condition of the knee and with respect to the variable amounts of energy absorption occurring while the members defining the joint follow the path of motion, the flexing and compression of the spring of Paul inherently allow it to absorb varied amounts of energy because of the coiled shape and connection points.
56. 58. Paul discloses the energy absorption assembly complements/augments energy absorbing function of cartilage thereby reducing the load on the cartilage compared to that of an untreated knee (the system of Paul comprises a flexible spring which when attached adjacent cartilage will inherently complement and augment the cartilage by absorbing some forces normally experienced).
Response to Arguments
Applicant's arguments filed 09/18/2025 have been fully considered but they are not persuasive.
The applicant’s arguments are all centered around Paul being disclosed as a spinal implant and not positioned within the knee. This is not persuasive because the prior art rejection has been modified to include the Ozark reference as a base reference. Ozark discloses his system used as multiple embodiments for different joints of the body. With respect to the knee Ozark specifically discloses a flexible member positioned along the side of the knee which maintains the full range of motion of the natural knee. The flexible members of Ozark and Paul have substantially the same function and structures outside of Paul not including the inner struts and is disclosed as compressing and offloading forces. Therefore a person of ordinary skill in the art would look to Paul to improve Ozark by being more compressible and offloading more forces while still maintaining the full range of motion.
In order to advance prosecution the applicant is advised to better define the pistons/spring configuration of the elected embodiment.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christopher D. Prone/ Primary Examiner, Art Unit 3774