DETAILED ACTION
The following is a final office action is response to communications received on 05/04/2026. Claims 1 & 19-46 are currently pending and addressed below.
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 .
Response to Arguments
Applicant's arguments filed 05/04/2026 have been fully considered but they are not persuasive. Applicant argues that none of the cited references is capable of teaching the claims as currently amended. Specifically, applicant argues that none of the references teaches the wherein said framework further includes a plurality of continuous structural members; wherein said structural members are oriented to define one or more preferential load paths; wherein said framework is configured to produce a direction-dependent elastic stiffness under physiological cyclic loading; and wherein said direction-dependent elastic stiffness is configured to match load transfer characteristics of surrounding bone, of the present application.
The examiner respectfully disagrees. A new ground(s) of rejection is made infra in view of Nakano et al. (US 2012/0064288) addressing all of the claim limitations as necessitated by amendment.
Any further arguments are moot as they do not apply to any of the references as being used in the current rejection.
Election/Restrictions
Claims 23-25, 41, 42 & 44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/24/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 19-22, 26-40, 43, 45 & 46 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 requires wherein said structural members are oriented to define one or more preferential load paths; wherein said framework is configured to produce a direction-dependent elastic stiffness under physiological cyclic loading; and wherein said direction-dependent elastic stiffness is configured to match load transfer characteristics of surrounding bone. Similarly, claim 46 requires forming within the body an oriented framework of structural members configured to produce direction-dependent elastic stiffness under cyclic loading.
However, the specification and figures fail to provide an explanation as to how (1) said structural members are oriented to define one or more preferential load paths; (2) said framework is configured to produce a direction-dependent elastic stiffness under physiological cyclic loading; and (3) said direction-dependent elastic stiffness is configured to match load transfer characteristics of surrounding bone. There is no indication of the device material (e.g., ceramic, polymer, metal), component structures (e.g., ribs, planks, framework), orientations, associated testing(s), component dimensions, component spacing(s), and/or force/impact requirements, which would result in the claimed language.
Claims 1, 19-22, 26-40, 43, 45 & 46 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. As discussed supra, the specification and figures fail to provide an explanation as to how said structural members are oriented to define one or more preferential load paths; wherein said framework is configured to produce a direction-dependent elastic stiffness under physiological cyclic loading; and wherein said direction-dependent elastic stiffness is configured to match load transfer characteristics of surrounding bone are provided. The specification merely discloses a method of making the invention using some of the same functional limitations and/or mechanical properties (i.e., anisotropic stiffness) used in the claims. There is no indication of: (1) the component/device (e.g., ribs, planks, and foundation) materials which would result in the claimed limitations; (2) associated testing(s) detailing the extent, location or magnitude of the claimed limitations; (3) any component dimensions, ratios, spacing(s), orientations which would result in the claimed limitations; or (4) any force/impact requirements, that would result in the claimed limitations.
Thus, the specification fails to teach one of ordinary skill how to make and/or use the full scope of the invention as claimed without undue experimentation.
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 1, 19-22, 26-40, 43, 45 & 46 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 pre-AIA the applicant regards as the invention.
Claim 1 states, wherein said structural members are oriented to define one or more preferential load paths; wherein said framework is configured to produce a direction-dependent elastic stiffness under physiological cyclic loading; and wherein said direction-dependent elastic stiffness is configured to match load transfer characteristics of surrounding bone. These limitations are unclear as the limitation merely states a function or property without providing any indication about how the function is performed or the property is obtained. The recited function/property does not follow from the structure recited in the claim so it is unclear whether the function/property requires some other structure or is simply a result of operating the implant in a certain manner. Further, after thoroughly mining the specification, it is unclear what exactly is meant by (1) one or more preferential load paths; (2) direction-dependent elastic stiffness under physiological cyclic loading; and (3) wherein said direction-dependent elastic stiffness is configured to match load transfer characteristics of surrounding bone. Appropriate correction is required.
Claim 46 states, an oriented framework of structural members configured to produce direction-dependent elastic stiffness under cyclic loading. This limitation is unclear as the limitation merely states a function or property without providing any indication about how the function is performed or the property is obtained. The recited function/property does not follow from the structure recited in the claim so it is unclear whether the function/property requires some other structure or is simply a result of operating the implant in a certain manner. Further, after thoroughly mining the specification, it is unclear what exactly is meant by an oriented framework of structural members configured to produce direction-dependent elastic stiffness under cyclic loading. Appropriate correction is required.
Claim 26 recites the limitation "said anisotropic property" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 26, 31, 32 & 37 recite the limitation "said anisotropic property" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites the limitation "said anisotropic stiffness" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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 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.
Claim(s) 1, 19-22, 26-39, 43, 45 & 46 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakano et al. (US 2012/0064288).
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Regarding Claim 1, as best understood (see 112 (a) and (b) rejections supra), Nakano teaches a method for producing a structural medical device (Fig 22A) configured for installation into a prepared cavity (i.e., femur), comprising: a) manufacturing a body including a body (shown) portion sized for a pressfit fixation into the prepared cavity; and b) disposing a framework (23) within said body portion during said manufacturing step a) wherein said framework includes a set of one or more structural elements (23) configured to produce an anisotropic (as the framework and structure are not symmetric) bulk material property in said body portion; wherein said framework further includes a plurality of continuous structural members (21 in Fig 2); wherein said structural members (21) are oriented to define one or more preferential load paths (Fig 22A shows members of the implant which would inherently be under some amount of load following implantation); wherein said framework is fully capable of producing a direction-dependent elastic stiffness under physiological cyclic loading; and wherein said direction-dependent elastic stiffness is capable of matching load transfer characteristics of surrounding bone.
Regarding Claim 19, Nakano teaches wherein said structural members are configured to carry loads along a first direction with greater stiffness than a direction orthogonal to said first direction.
Regarding Claim 20, Nakano teaches wherein said structural members form continuous load-bearing members (the implant which would inherently be under some amount of load following implantation).
Regarding Claim 19, Nakano teaches wherein said framework defines preferential load paths (vertically oriented walls 21) aligned with physiological forces.
Regarding Claim 22, Nakano teaches wherein said framework includes ribs (21) having a first orientation within said framework.
Regarding Claim 26, as best understood (see 112 rejection supra), Nakano teaches wherein said anisotropic property is fully capable of including a reversible elastic deformation (upon removal from bone).
Regarding Claim 27, Nakano teaches wherein said framework is fully capable of resisting fatigue failure under repeated loading cycles (as it is a permanent implant).
Regarding Claim 28, Nakano teaches wherein said anisotropic stiffness is fully capable of long-term cyclic loading (as it is a permanent implant).
Regarding Claim 29, Nakano teaches wherein said anisotropic property includes a directional modulus gradient (as the implant and materials are asymmetric, the implant would include a directional gradient).
Regarding Claim 30, Nakano teaches wherein said body includes multiple regions having different directional stiffness (as the implant and materials are asymmetric, the implant would include a different directional stiffness).
Regarding Claim 31, as best understood (see 112 rejection supra), Nakano teaches wherein said anisotropic stiffness is fully capable of promoting load transfer to surrounding bone (as the implant resides in the intermedullary cavity).
Regarding Claim 32, as best understood (see 112 rejection supra), Nakano teaches wherein said anisotropic property is fully capable of reducing stress shielding (to preserve native bone).
Regarding Claim 33, as best understood (see 112 rejection supra), Nakano teaches wherein said anisotropic stiffness is fully capable of approximating cortical bone in at least one direction (to reduce stress shielding).
Regarding Claim 34, Nakano teaches wherein deformation is not produced through particle neck collapse (not implanted wherein no deformation occurs).
Regarding Claim 35, Nakano teaches wherein said framework (21) operates independently of diffusion-bonded powder particles.
Regarding Claim 36, Nakano teaches wherein said structural members (21) are free of sintered particle interfaces.
Regarding Claim 37, only the product will be examined. (Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)); see MPEP 2113). To the extent that the process steps further define the structure of the device, they have been considered. In the instant case, none of the process steps recited in claim 37 further define or add any structural limitations to the component.
Regarding Claim 38, Nakano teaches wherein said framework (21) includes a first set of structural members having a first orientation (medial-lateral) and a second set of structural members having a second orientation (anterior-posterior) different from the first orientation, the first and second sets having different rigidities (as there are different amounts and sizes of members 21 in both the M-L direction and the A-P direction) collectively configured to produce said anisotropic bulk material property.
Regarding Claim 39, Nakano teaches wherein said first and second sets of structural members intersect or cooperate (Figs 2 & 22A) and are fully capable of collectively forming load-bearing nodes further capable of increasing torsional strength.
Regarding Claim 43, Nakano teaches wherein the device comprises a stem for insertion into a long bone (Fig 22A).
Regarding Claim 45, Nakano teaches wherein said manufacturing step includes additive manufacturing [0018].
Regarding Claim 46, as best understood (see 112 (a) & (b) rejections supra), Nakano teaches a method of manufacturing [0018] an anisotropic (as the framework and structure are not symmetric) medical implant comprising: forming a body (shown); and forming within the body an oriented framework (21) of structural members fully capable of producing direction-dependent elastic stiffness under cyclic loading.
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 BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie 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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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774
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