DETAILED ACTION
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 .
Claims 1-9 and 21-27, of record 2/12/2026, are pending and subject to prosecution. Claims 1 and 23 are amended.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 1-9 and 21-27 are rejected under 35 U.S.C. 112(a):
The applicant asserts that the composition of the plurality of individual periosteum fibers of amended claim 1 is inherently provided in an unstressed state with greater compressive elasticity versus periosteum fibers in bone-anchored periosteum or a plurality of fused periosteum fibers (Applicant Remarks, page 9-10).
The applicant’s argument has been considered but is not found wholly persuasive.
According to MPEP 2163.07(a), by disclosing in a patent application a device that inherently has a property, a patent application necessarily discloses that function, even though it says nothing explicit concerning it. The applicant argues that periosteal fibers, in the context of periosteum attached to bone or fused periosteal fibers, are intrinsically stressed and therefore possess less compressive elasticity than isolated fibers. The instant specification does not address or define the limitation “compressive elasticity”. The broadest reasonable interpretation is therefore considered to be the compressive modulus of elasticity, the ability of a material to resist deformation under compressive load (See Liu et al., Introduction).
McBride et al. establish that fibers in intact periosteum experience higher axial strain (along the long axis of the bone) versus circumferential strain and that periosteal tissue exhibits shrinkage following isolation from bone largely in the axial direction (See page 1956, col. 2, full ¶1-2 and page 1957, col. 2, full ¶2), which supports the existence of anisotropic mechanical properties in periosteum. McBride et al. conducted their experiments by stretching the tissue samples (See page 1955, col. 2, full ¶3). It is noted that McBride et al. do not assess, or opine on, the compressive elasticity of periosteum, and no data on this functional aspect have been disclosed in the instant application. A greater compressive elasticity cannot therefore be considered an inherent property of individual periosteum fibers compared to periosteum fibers within bone-associated periosteum.
Independent claim 1 also requires that the individual periosteum fibers provide the composition with greater compressive elasticity than fused periosteum fibers, however, no evidence of this property has been provided either. As such, the limitations directed toward compressive elasticity constitute new matter that is not supported by the disclosure.
The rejection is maintained in modified form to address amended limitations.
Maintained Rejections
Claim Interpretation
Claim 1 has been amended to require “greater compressive elasticity”. This limitation is not defined by the instant specification. The broadest reasonable interpretation is therefore considered to be a greater compressive modulus of elasticity, i.e., a greater ability of a material to resist deformation under compressive load (See Liu et al., Introduction).
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 1-9 and 21-27 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 claims 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The new limitation of “greater compressive elasticity” in instant claims appears to represent new matter. MPEP 2163.06(I) notes, “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112(a), pre-AIA first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” The applicant has not identified any support for this limitation in the specification, and a review of the specification by the Examiner did not find any specific basis for the recited limitation. As noted by the MPEP, new matter includes not only the addition of wholly unsupported subject matter but may also include the introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure. Such introduction is a violation of the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996).
Specifically, the instant application does not provide any discrete information about the invention’s functional qualities. There is no characterization of the compressive elasticity of the invention, much less a comparison of its compressive elasticity to that of a matrix of periosteum fibers within a periosteum layer of bone or that of fused periosteum fibers shorter than a given size. Claim 1 defines the composition, in part, by means of a functional limitation, “greater compressive elasticity e”. However, the instant application lacks any data that explicitly demonstrate that the instant invention has greater compressive elasticity than periosteum or fused periosteum fibers or data that suggest or support a finding that the structure of the instant invention would likely have greater compressive elasticity. Such physical or structural data are required to support the functional limitation of claim 1 and establish that the applicant had possession of and/or fully envisaged the invention. In the absence of supporting evidence, the amended functional limitation represents new matter and is properly rejected as a written description deficiency under 35 U.S.C. 112(a).
Conclusion
THIS ACTION IS MADE FINAL. 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 JENNIFER S SPENCE, whose telephone number is 571-272-8590. The examiner can normally be reached M-F 8:30-5:30.
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/J.S.S./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
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