DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/07/2025 has been entered.
Priority
This application claims priority from provisional application 61193396, filed 11/24/08.
Status of Claims
Claims 32-51 are pending.
Claims 41-51 have been withdrawn.
Claims 1-31 have been cancelled.
Election/Restrictions
Applicant elected Invention 1 (Method of use) without traverse in the reply filed on 1/22/14. The applicant failed to elect a single species from the listed requirement, but in order to advance prosecution the examiner has withdrawn the species election requirement. It is noted, for the sake of election by original presentation, that the claims are solely directed at the single structures of Figures 4A-C with the openings tapered sections, and pockets.
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.
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: means of the cushion’s material flexibility and fluid movement in claim 34.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Objections
In view of the applicant’s amendments the objections to claim 35 have been withdrawn.
Claim Rejections - 35 USC § 112
In view of the applicant’s amendments the 112 rejections to claims 33, 34, and 40 have been withdrawn.
Claim Rejections - 35 USC § 102
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 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 32-40 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Swartz USPN 5,344,459.
32. Swartz discloses a method for implanting a cushion (Figure 7) in a patient's knee joint between the patient's femur and tibia bones (Figure 12), the method comprising the steps of:
providing the cushion made from a flexible material (4:24-30) comprising a plurality of adjacent pockets (upper and lower C-shaped portions Figure 8), with a fluid filling the interior of the plurality of pockets cushion (5:54-59) such that a rupture of a first pocket results in the fluid draining from ruptured first pocket and not from an adjacent second pocket (since pockets are separate a rupture of a side wall of one does not impact the adjacent pocket) wherein two directly adjacent pockets share a common partition wall (upper and lower C-shaped portions comprise a common partition wall as the top and bottom of the respective portions Figure 8)
orienting the cushion such that the first pocket and the adjacent second pocket are both under a single condyle of the patient (Figure 7 shows two pockets arranged to be under each condyle) and
- fitting the cushion in the space between the patient's femur and tibia bones (Figure 12).
33. Swartz discloses the plurality of pockets (inner C-shaped portions Figure 7) are made from a flexible material (the pockets are expandable with air and or fluid making them inherently flexible), and a fluid filling an interior of the pocket (5:54-59), the pocket being sized to fit in a space between the patient's femur and tibia bones (Figure 12).
34. Swartz discloses the pockets are attached to the tibia and femoral bones (when surgery is completed the pockets are in direct contact which is considered to read on the attachment) so that the pocket is adapted to allow a gliding movement between the tibia and femur by means of the cushion’s material flexibility and fluid movement (the gelled fluid provides a frictionless/effortless contact and movement within the knee joint).
35. Swartz discloses the cushion has a first fixating section attaching the top of the cushion to the bottom of the femur at, at least a first point of attachment (the entire upper surface of the cushion is contacting and fixated to the femur), and a second fixating section attaching the cushion to the top of the tibia at, at least a second point of attachment (the entire lower surface of the cushion is contacting and fixated to the tibia) so that, as the femur moves relative to the tibia when a patient bends his or her knee joint, the position of the first and second points of attachment are caused to move relative to one another in a direction substantially more perpendicular than parallel with a length axis of the tibia bone (when the patient with the cushion of Swartz bends his knee the attachment surfaces will expand upward and away from each other in the same manner as the applicant’s invention).
36. Swartz discloses the cushion is sized and formed with a tapered central portion (narrowed middle section shown in Figures 7 or 9), so as to allow accommodation of cruciate ligaments extending between the femur and tibia (Figures 7, 9, and 12), wherein the cushion has a size substantially corresponding to a meniscus originally in the patient's knee joint between the patient's femur and tibia bones (Figure 12).
37. 39. and 40. Swartz discloses its known in the art to provide a central through hole/opening such that it can accommodate two interior cruciate ligaments extending between the patient's femur and tibia bones (the larger opening in Figure 9 is capable of accommodating at least 2 ligaments), wherein said opening is placed substantially in the center of the cushion through which the ligaments pass (Figure 9) so that the cushion is shaped substantially like a bow tie (Figures 7 and 9).
38. Swartz discloses the fluid is a gel (5:57-59).
Response to Arguments
Applicant's arguments filed 11/07/2025 have been fully considered but they are not persuasive. The applicant argues that the prior art fails to disclose the newly claimed adjacent pockets comprise a common partition wall. This is not persuasive because Swartz clearly discloses his implant comprises multiple interior pockets configurations including 2 pockets sharing common partition walls including. Swartz includes one embodiment shown in Figure 8 and another in Figure 6, which both include shared/touching partition walls.
Conclusion
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 on Monday-Friday 10 am - 6 pm (HST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached on (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
/CHRISTOPHER D. PRONE/
Examiner, Art Unit 3738