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 .
Election/Restrictions
Applicant's election with traverse of claims 16-27 in the reply filed on 11/24/2025 is acknowledged. The traversal is on the ground(s) that the single general inventive concept can be found in claims 16 and 28, which the restriction requirement does not assert are disclosed by Liden. Accordingly, Applicant respectfully requests that the restriction requirement be withdrawn. Applicant’s argument is found to be persuasive and hence the restriction requirement has been withdrawn and claims 16-30 are examined.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the struts described in claims 19 and 20 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract includes the legal phraseology “comprises”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 17-27 are objected to because of the following informalities: the limitation, “Brace according to claim 16…” should read “The brace according to claim 16…”. Appropriate correction is required.
See MPEP 608.01(n) IV:
IV. CLAIM FORM AND ARRANGEMENT
A singular dependent claim 2 could read as follows:
2. The product of claim 1 in which . . . .
A series of singular dependent claims is permissible in which a dependent claim refers to a preceding claim which, in turn, refers to another preceding claim.
Claim 19 is objected to because of the following informalities: the term “…their…” is a pronoun should be replaced with the structure to which applicant is seeking patent protection. Appropriate correction is required.
Claim 28 is objected to because of the following informalities: the limitation, “Method for manufacturing….” should read “A method of manufacturing…” . Appropriate correction is required.
Claims 29-30 are objected to because of the following informalities: the limitations, “Method according to claim 28…” should read “The method according to claim 28…”. Appropriate correction is required.
See MPEP 608.01(n) IV:
IV. CLAIM FORM AND ARRANGEMENT
A singular dependent claim 2 could read as follows:
2. The product of claim 1 in which . . . .
A series of singular dependent claims is permissible in which a dependent claim refers to a preceding claim which, in turn, refers to another preceding claim.
Claim 16 is objected to because of the following informalities: the limitations, “A brace for management of an anatomical structure comprising a primary anatomical structure, a secondary anatomical structure, and a joint and/or an injury between the primary anatomical structure and the secondary anatomical structure,
the brace comprising a first brace part extending from a first primary brace part end to a first secondary brace part end and being adapted to be positioned to cover a first part of the anatomical structure extending over the joint and/or injury such that the first primary brace part end is located on the primary anatomical structure and the first secondary brace part end is located on the secondary anatomical structure,
the first brace part comprising a first rigid outer shell and one or more first lattice structures attached to a first inner side of the first rigid outer shell, the one or more first lattice structures having a first height in a height direction normal to the first inner side of the first rigid outer shell in a non-compressed state, and
the one or more first lattice structures being adapted to:
- in response to increasing compression from the non-compressed state to a first compression amount in the height direction, exhibit stress increasing at a first rate,
- in response to increasing compression from the first compression amount to a second compression amount in the height direction, wherein the second compression amount corresponds to more than 50% of the first height, exhibit stress being uniform or increasing at a second rate lower than the first rate, and
- in response to decreasing compression from the second compression amount to the non- compressed state in the height direction, return to the first height,
the one or more first lattice structures includes a first primary lattice structure covering a first primary region and a first secondary lattice structure covering a first secondary region, wherein the average stress exhibited by the first primary lattice structure in response to compression between the first compression amount and the second compression amount in the first primary region is lower than the average stress exhibited by the first secondary lattice structure in response to compression between the first compression amount and the second compression amount in the first secondary region”, should read:
A brace for management of an anatomical structure comprising a primary anatomical structure, a secondary anatomical structure, and a joint and/or an injury between the primary anatomical structure and the secondary anatomical structure,
the brace comprising a first brace part extending from a first primary brace part end to a first secondary brace part end and being configured
the first brace part comprising a first rigid outer shell and one or more first lattice structures attached to a first inner side of the first rigid outer shell, the one or more first lattice structures having a first height in a height direction normal to the first inner side of the first rigid outer shell in a non-compressed state, and
the one or more first lattice structures being adapted to:
- in response to increasing compression from the non-compressed state to a first compression amount in the height direction, exhibit stress increasing at a first rate,
- in response to increasing compression from the first compression amount to a second compression amount in the height direction, wherein the second compression amount corresponds to more than 50% of the first height, exhibit stress being uniform or increasing at a second rate lower than the first rate, and
- in response to decreasing compression from the second compression amount to the non- compressed state in the height direction, return to the first height,
the one or more first lattice structures includes a first primary lattice structure covering a first primary region and a first secondary lattice structure covering a first secondary region, wherein the average stress exhibited by the first primary lattice structure in response to compression between the first compression amount and the second compression amount in the first primary region is lower than the average stress exhibited by the first secondary lattice structure in response to compression between the first compression amount and the second compression amount in the first secondary region. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: the limitations, “wherein the brace is adapted to be positioned on the anatomical structure such that the first primary region is positioned on a part of the anatomical structure having a bony prominence and/or such that the first secondary region is positioned on a part of the anatomical structure with soft tissue” should read, wherein the brace is configured to be positioned on the anatomical structure such that the first primary region is positioned on a part of the anatomical structure having a bony prominence and/or such that the first secondary region is positioned on a part of the anatomical structure with soft tissue. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: the limitation, “…wherein the brace is adapted to be positioned on the anatomical structure such that the first primary region is positioned closer to the joint and/or injury of the anatomical structure than the first secondary region, such as over the joint and/or injury” should read, wherein the brace is configured . Appropriate correction is required.
Claim 24 is objected to because of the following informalities: the limitations, “comprising one or more fasteners adapted to fasten the brace to the anatomical structure, the one or more fasteners may include one or more straps” should read, comprising one or more fasteners configured . Appropriate correction is required.
Claim 25 is objected to because of the following informalities: the limitations, “comprising a second brace part extending from a second primary brace part end to a second secondary brace part end and being adapted to be positioned to cover a second part, e.g. opposite the first part, of the anatomical structure extending over the joint and/or injury such that the second primary brace part end is located on the primary anatomical structure and the second secondary brace part end is located on the secondary anatomical structure, the second brace part comprising a second rigid outer shell” should read, comprising a second brace part extending from a second primary brace part end to a second secondary brace part end and being configured on the secondary anatomical structure, the second brace part comprising a second rigid outer shell. Appropriate correction is required.
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.
Claims 16-30 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “rigid” in claim 16 is a relative term which renders the claim indefinite. The term “rigid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
As to claim 16, in lines 11-12, the limitation, “…in a height direction normal to the first inner side of the first rigid outer shell…” renders the claim indefinite as it is unclear how the term “normal” is being utilized in the context and configuration of the structural relationship.
Claim 16 recites the limitation "the average stress" in line 24. There is insufficient antecedent basis for this limitation in the claim.
The term “closer” in claim 22 is a relative term which renders the claim indefinite. The term “closer” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 22, the phrase "such as" in line 3 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 23 recites the limitation "the average stress" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
As to claim 24, the term “…the one or more fasteners may include one or more straps” renders the claim vague and indefinite as the term “may” does not positively recite the "one or more straps" and renders the claim indefinite because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired.
Regarding claim 25, the phrase "for example or e.g." in line 3 of the claim, renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
As to claim 26, in lines 1-2, the limitation, “…in a height direction normal to the second inner side of the second rigid outer shell…” renders the claim indefinite as it is unclear how the term “normal” is being utilized in the context and configuration of the structural relationship.
Claim 27 recites the limitation "the average stress" in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the average stress" in line 25. There is insufficient antecedent basis for this limitation in the claim.
As to claim 28, in lines 32-33, the limitation, “…the one or more first lattice structures are arranged normal to the first inner side of the first rigid outer shell…” renders the claim indefinite as it is unclear how the term “normal” is being utilized in the context and configuration of the structural relationship.
Claims 17-21 and 29-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite since they depend directly or indirectly on rejected base claims 16 and 28 and therefore, contain the same deficiencies.
Allowable Subject Matter
Claims 16-28 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
The closest prior art drawn to Alireza et al. (GB 2580413A) fails to show or make obvious the claimed combinations of elements particularly the limitations as set forth in independent claims 16 and 28 and dependent claims 17-27 and 29-30 which recite features not taught or suggested by the prior art drawn to Alireza et al. It is respectfully submitted that the cited references, i.e., Alireza et al. considered either alone or in combination, fail to disclose, suggest, or otherwise render obvious the claimed combinations of features presently set forth in independent claim 16 and 28. More particularly, it is respectfully submitted that the cited reference fail to disclose, suggest, or otherwise render obvious the claimed combination of features presently set forth in independent claims 16 and 28, including the combination of features of:”…in response to increasing compression from the first compression amount to a second compression amount in the height direction, wherein the second compression amount corresponds to more than 50% of the first height, exhibit stress being uniform or increasing at a second rate lower than the first rate, and - in response to decreasing compression from the second compression amount to the non- compressed state in the height direction, return to the first height, the one or more first lattice structures includes a first primary lattice structure covering a first primary region and a first secondary lattice structure covering a first secondary region, wherein the average stress exhibited by the first primary lattice structure in response to compression between the first compression amount and the second compression amount in the first primary region is lower than the average stress exhibited by the first secondary lattice structure in response to compression between the first compression amount and the second compression amount in the first secondary region”, in combination with the other elements (or steps) of the apparatus and method recited in the claims. Accordingly, a prima facie case of obviousness or an anticipation rejection cannot be established with respect to the claimed subject matter as set forth in claims 16 and 28.
Claims 17-27 and 29-30 are allowed insofar as they depend from the allowed base claim 16 and 28.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786