Detailed Action
This is the first office action on the merits for US application number 19/147,565.
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 .
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Examiner notes that the abstract is currently the first two pages of WO 2024/153973, which is not in narrative form or a single paragraph within the range of 50 to 150 words in length.
Claim Objections
Claim(s) 1-10 is/are objected to because of the following informalities:
Claim 1 line 1 should read “A device
Claims 2-9 line 1 should read “The device
Claim 10 line 1 should read “A process1, the process comprising:”.
Appropriate correction is required.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
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.
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.
Claim(s) 1-10 is/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(s) 1 recites/recite the limitation "the healing" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “configured to support [[the ]]healing of an osseous fracture”.
Claim(s) 1 is/are unclear with regards to “an osseous fracture comprising: - a main structure (2) … comprising:- a plate (20) … fastening elements (3)….at least one sensor” in lines 1-7 and how this can be construed to not be claiming the human body and how such can be reasonably construed to include a plate, fastening elements, and a sensor and where such is supported in the original disclosure. Examiner is interpreting this as referring to, and suggests amending as, “A device, the device comprising:”.
Claim(s) 1 is/are unclear with regards to “an expansion surface (2a)” in line 3 and how the disclosed surface 2a is disclosed to expand or be capable of expanding to thus represent an expansion surface. Examiner is interpreting broadly as referring to as surface and suggests amending to clarify.
Claim(s) 1 is/are unclear with regards to “and characterized by:” in line 9 and what is characterized by the limitations that follow, i.e. as written, this appears to modify the sensor but the limitations that follow appear to that this is intended to modify the device. Examiner is interpreting broadly as referring to the device and suggests amending to clarify.
Claim(s) 1 is/are unclear with regards to “means of a three-dimensional moulding process” in line 10 and the scope of these “means” and where such is defined in the specification to enable one to ascertain the claimed scope and equivalents thereof. Examiner is interpreting this as referring to, and suggests amending as, “said main structure (2) is at least in part made by
Claim(s) 10 is/are unclear with regards to “means of a three-dimensional moulding process” in line 3 and the scope of these “means” and where such is defined in the specification to enable one to ascertain the claimed scope and equivalents thereof. Examiner is interpreting this as referring to, and suggests amending as, “said main structure (2) by
Claim(s) 2-9 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mikhail et al. (US 2019/0038214, hereinafter “Mikhail”).
The claimed phrase “made by” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claim 1, Mikhail discloses a device (10, Figs. 1-9) capable of aiding in osteosynthesis (Figs. 1 and 7-9, ¶s 30 and 68) capable of supporting healing of an osseous fracture (Figs. 1 and 7-9, ¶s 30 and 68), the device comprising: - a main structure (602, 610) defining an expansion surface (Figs. 7-9) and comprising:- a plate (114/602, 610, Figs. 7-9) extending mainly along said expansion surface (Figs. 7-9),- fastening elements (screws of ¶s 70, 84, and 85, Figs. 7-9, ¶s 70, 84, and 85) capable of integrally constraining said plate to a respective osseous fragment (Figs. 7-9),- at least one sensor (102s) integrally constrained to said main structure (Figs. 7-9, ¶s 33-35, 39, 42, and 72) and capable of detecting at least one mechanical parameter (¶s 33-35, 42, and 72), and characterized by: - said main structure is at least in part made by a three-dimensional moulding process (Figs. 7-9; where ¶s 30 and 76 disclose that 114/602 and 610 are comprised of PEEK) and said at least one sensor is incorporated in said main structure during said three-dimensional moulding process (Figs. 7-9).
As to claim 2, Mikhail discloses that said plate comprises a plurality of through holes (616s) capable of housing at least partially said fastening elements (Figs. 7-9, ¶s 70, 84, and 85).
As to claim 3, Mikhail discloses that said fastening elements comprise a plurality of screws (as defined, Figs. 7-9, ¶s 70, 84, and 85) each including a head (Figs. 7-9).
As to claim 4, Mikhail discloses that said screws are, in use, arranged transversely to said expansion surface (Figs. 7-9, ¶s 70, 84, and 85; where ¶85 discloses that the screws extend through 616 and into bone) and said head is at least partially aligned with said expansion surface (Figs. 7-9).
As to claim 5, Mikhail discloses that said at least one sensor is capable of detecting tensile and compression forces acting on said main structure (¶72).
As to claim 6, Mikhail discloses that said at least one sensor comprises a piezoelectric element (¶s 34 and 35).
As to claim 7, Mikhail discloses that said piezoelectric element is capable of generating an electrical signal (Fig. 4, ¶s 55, 57, and 75) capable of being detected from an external device (116, via measurement and transmission by 104 and 110, Figs. 1, 2, 4, and 5).
As to claim 8, Mikhail discloses comprising a plurality of said sensors (102a, 102b, Fig. 7, ¶48).
As to claim 9, Mikhail discloses that said plate is made of biocompatible plastic material (¶s 30 and 76 disclose that 114/602 and 610 are comprised of PEEK).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mikhail et al. (US 2019/0038214, hereinafter “Mikhail”) in view of Li et al. (US 2020/0214598, hereinafter “Li”).
As to claim 10, Mikhail discloses the invention of claim 1 as well as a process (Figs. 1 and 7-9) capable of manufacturing the device (Figs. 1 and 7-9), the process comprising: - forming said main structure (Figs. 1 and 7-9), and - incorporating said at least one sensor in said main structure (Figs. 1 and 7-9).
Mikhail is silent to the forming is by a three-dimensional moulding process, and the incorporating being during said forming phase.
Li teaches a process (Fig. 4E, ¶s 34, 90, and 147) capable of manufacturing a similar device (400, 401, Fig. 4E, ¶s 34, 90, and 147) capable of aligning and securing within a patient’s body (¶s 131 and 134), the device comprising: - a main structure (400) defining an expansion surface (Fig. 4E) and comprising:- a plate (Fig. 4E) extending mainly along said expansion surface (Fig. 4E), and - at least one sensor (401) integrally constrained to said main structure (Fig. 4E) and capable of detecting at least one mechanical parameter (¶147), and characterized by: - said main structure is at least in part made by a three-dimensional moulding process (Fig. 4E, ¶s 34, 90, and 147) and said at least one sensor is incorporated in said main structure during said three-dimensional moulding process (Fig. 4E, ¶s 34, 90, and 147); where Li teaches known alternates with the sensor on the periphery of the plate in Figs. 4C and 4D (¶132 and 133).
Mikhail discloses the claimed invention except for specific manufacturing details instead of explicitly disclosing the forming with three-dimensional moulding process and the sensor incorporated during the forming. Li shows that moulding the sensor within the plate is an equivalent structure known in the art. Therefore, because these two methods were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to specify that the forming to be with three-dimensional moulding process and the sensor to be incorporated during the forming. That is, one of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify forming and incorporating as disclosed by Mikhail to include forming with three-dimensional moulding process and the sensor incorporated during the forming as taught by Li in order to reduce patient exposure to the sensor reduce exposure of the sensor device to bodily fluids (Li ¶134).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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