DETAILED ACTION
This is the initial Office action for non-provisional application 18/473,089 filed September 22, 2023, which is a continuation of PCT/IB22/00167 filed March 23, 2022, which claims priority from provisional applications 63/167,758 filed March 30, 2021 and 63/166,186 filed March 25, 2021. Claims 1-17 and 28, as presented in the preliminary amendments filed May 12, 2026, are currently pending.
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 . 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.
Election/Restrictions
Applicant’s election without traverse of Invention I in the reply filed on May 12, 2026 is acknowledged.
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, 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.
Claims 1, 2, 6, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Chhatrala (WO 2020/115769) in view of Hargrave (US 2007/0100266).
Regarding claim 1, Chhatrala discloses a conformable orthosis comprising a scaffold (stabilization device 100+110) having a longitudinal axis and being configured to be removably placed over a body surface, wherein the scaffold (100+110) is divided into a plurality of scaffold cells (lateral slab 1) having first and second sides and tops and bottoms, wherein the tops and bottoms on axially adjacent scaffold cells (1) are separable from each other along circumferential lines, and a first circumferential connector (connector assembly 3) pivotally attached to the first and second sides of at least some of the scaffold cells (1), wherein the first circumferential connector (3) is configured to detachably and adjustably connect to the first and second sides of the at least some of the scaffold cells (1), and wherein the tops and bottoms on axially adjacent scaffold cells (1) are adjustably coupled to each other (via device fastener mechanism 500) (Figs. 7-11; page 7, lines 27-30; page 12, lines 1-6).
Although Chhatrala discloses that two or more scaffold cells may be connected by means of any mechanism as per requirement (page 5, lines 4-5; claim 9), Chhatrala fails to teach a second circumferential connector pivotally attached to the second side of at least some of the scaffold cells such that the first and second sides on circumferentially adjacent scaffold cells are separable along axial lines.
Hargrave discloses a conformable orthosis (brace 100) comprising a scaffold (casing 111) having a longitudinal axis and being configured to be removably placed over a body surface, wherein the scaffold (111) is divided into a plurality of scaffold cells (medial component 102, lateral component 104) having first and second sides, wherein the first and second sides on circumferentially adjacent scaffold cells (102, 104) are separable along axial lines, and a first circumferential connector (straps 103a, 105a) pivotally attached to the first side of at least some of the scaffold cells (102, 104) and a second circumferential connector (straps 103b, 105b) pivotally attached to the second side of at least some of the scaffold cells (102, 104), wherein the first and second circumferential connectors (103, 105) are configured to detachably connect at an adjustable distance therebetween (Figs. 1A-1B; ¶ 0031-0032 & 0046).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the conformable orthosis taught by Chhatrala to include an scaffold cell circumferentially adjacent another scaffold cell and adjustable connected by a second circumferential connector pivotally attached to the second side of the scaffold cells such that the first and second sides on the circumferentially adjacent scaffold cells are separable along axial lines as taught by Hargrave for the purpose of adjustably surrounding a patient limb on opposing sides thereof to achieve a desired support.
Regarding claim 2, the combination of Chhatrala and Hargrave discloses the invention substantially as claimed, as described above, and Chhatrala further discloses axial tethers (cap strips 510) which adjustable coupled the tops and bottoms of axially adjacent scaffold cells (1) (Figs. 9-11; page 12, lines 1-6).
Regarding claim 6, the combination of Chhatrala and Hargrave discloses the invention substantially as claimed, as described above, and Chhatrala further discloses spacers (socket strips 520) configured to be placed between the tops and bottoms of axially adjacent scaffold cells (1) (Figs. 9-11; page 12, lines 1-6).
Regarding claim 14, the combination of Chhatrala and Hargrave discloses the invention substantially as claimed, as described above, wherein the scaffold of the conformable orthosis taught by the combination of Chhatrala and Hargrave is configured to circumscribe a body limb, a body joint, or a body torso (Chhatrala: Fig. 11; Hargrave: Figs. 1A-1B).
Regarding claim 15, the combination of Chhatrala and Hargrave discloses the invention substantially as claimed, as described above, and Chhatrala further discloses that the scaffold (100+110) comprises an orthotic aid (the adjustable limb stabilization device aids in treating injured limbs; page 4, lines 22-27).
Regarding claim 16, the combination of Chhatrala and Hargrave discloses the invention substantially as claimed, as described above, and Chhatrala further discloses that the scaffold (100+110) comprises a three-dimensional lattice (Fig. 11).
Regarding claim 17, the limitation “wherein the three-dimensional lattice was produced by three-dimensional printing using a scan of the body surface as a model” is a product-by-process limitation. “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) (citations omitted). In this case, since the scaffold of the conformable orthosis taught by the combination of Chhatrala and Hargrave comprises a three-dimensional lattice, the product taught by the combination of Chhatrala and Hargrave is the same as or obvious from the claimed scaffold such that the claimed process of producing that product as recited in claim 17 is unpatentable.
Allowable Subject Matter
Claims 3-5, 7-13, and 28 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 3 is indicatable allowable because the combination of Chhatrala and Hargrave fails to teach that the axial tethers pass through a pivotal axis of at least some of the first and second circumferential connectors in combination with the limitations of claims 1 and 2.
Claim 4 is indicatable allowable because the combination of Chhatrala and Hargrave fails to teach at least one uptake spindle for adjustably tightening one or more axial tethers in combination with the limitations of claims 1 and 2.
Claim 5 is indicatable allowable based on its dependence from claim 4.
Claim 7 is indicatable allowable because the combination of Chhatrala and Hargrave fails to teach that axially adjacent scaffold cells are connected by threaded fasteners in combination with the limitations of claim 1.
Claim 8 is indicatable allowable based on its dependence from claim 7.
Claim 9 is indicatable allowable because the combination of Chhatrala and Hargrave fails to teach that the first and second circumferential connectors comprise rotating spindles with radially extending coupling tabs in combination with the limitations of claim 1.
Claims 10-13 are indicatable allowable based on their dependence from claim 9.
Claim 28 is indicatable allowable because the combination of Chhatrala and Hargrave fails to teach that the axial tethers pass through or along one or more of the first or second circumferential connectors in combination with the limitations of claims 1 and 2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Keri J. Nelson whose telephone number is 571-270-3821. The examiner can normally be reached Monday - Friday, 9am - 4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael E. Bredefeld, can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KERI J NELSON/Primary Examiner, Art Unit 3786 6/9/2026
Prosecution Insights