BRACE FOR MANAGEMENT OF AN ANATOMICAL STRUCTURE

§101 §103 §112 §DP

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 . Priority Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Claim Objections Claims 16, 25 and 28 objected to because of the following informalities: Each of these claims includes bullet points that appear as open circles. The bullet points appear unclear as they could be interpreted as a letter or other symbol. It is suggested that they are deleted. Appropriate correction is required. Claims 17-24 are objected to because of the following informalities: the limitation, “Brace according to” should read “The brace according to….” Appropriate correction is required. Claim 25 is objected to because of the following informalities: the limitation “Method for manufacturing…” should read --A method for manufacturing--. Appropriate correction is required. Claims 26-28 and 30 are objected to because of the following informalities: the limitation, “Method according to claim 25” should read --The method according to claim 25--. Appropriate correction is required. Claims 29 is objected to because of the following informalities: the limitation, “Method according to claim 28” should read --The method according to claim 25--. 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. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: locking mechanism in claim and 25. Claim limitation “locking mechanism” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “mechanism” as a substitute for means coupled with functional language “locking” without reciting sufficient structure to achieve the function. Furthermore, the generic place holder is not preceded by a structural modifier. A review of the specification shows that the corresponding structure of the 35 U.S.C. 112(f) or pre-AIA U.S.C. 112, sixth paragraph limitation “locking mechanism” described in the specification includes an outer shell, a clip, or a hinge (Applicant’s specification, page 17, lines 1-15). Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. 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 claims 16 and 25 and 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. Claim 16 recites the limitation "the center" in line 12 and claim 25 recites the limitation “the center” in line 7. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as --a center--. As claims 17-24 depend from claim 16, they are rejected for at least the same reasons as claim 16. As claims 26-30 depend from claim 25, they are rejected for at least the same reasons as claim 25. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 20 recites the broad recitation a plurality of times, and the claim also recites such as at least 10 times which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purposes of examination, the limitation “such as at least 10 times” will be interpreted as merely exemplary. The term “substantially perpendicular” in claim 23 is a relative term which renders the claim indefinite. The term “substantially” 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. For the purposes of examination, the term will be interpreted as --perpendicular--. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 26 recites the broad recitation of additive manufacturing, and the claim also recites, such as 3D printing which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purposes of examination, the limitation “such as 3D printing” will be interpreted as merely exemplary. In the present instance, claim 27 recites the broad recitation of additive manufacturing, and the claim also recites, such as 3D printing which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purposes of examination, the limitation “such as 3D printing” will be interpreted as merely exemplary. The term “substantially similar” in claim 30 is a relative term which renders the claim indefinite. The term “substantially” and the term “similar” are 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. For the purposes of examination, the term will be interpreted as --providing a second brace part and attaching the first brace part and the second brace part--. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Section 33(a) of the America Invents Act reads as follows: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. Claims 16-24 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 16, lines 6-8 recites, “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” which positively claims the human body. Language such as “configured to” or “adapted for” is recommended to avoid positively claiming human body parts. For example, the claim could be amended to recite --such that the first primary brace part end is configured to be located on the primary anatomical structure and the first secondary brace part end is configured to be located on the secondary anatomical structure”. As claims 17-24 depend from claim 16, they are rejected for at least the same reasons as claim 16. 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. Claim(s) 16-20, 25-27 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Summit (US 2011/0301520). Regarding claim 16, Summit discloses in an embodiment of Figs. 40-41 a brace ([0077]) for management of an anatomical structure ([0077], capable of intended use), the brace comprising a first brace part (Figs. 40, 41; e.g. any part is a first brace part) the first brace part comprises:- a distal shell (534, 536) (shell is distal to user relative to pad; annotated Fig. 40 below; Fig. 36, step 671, pads are fabricated for a brace; [0066]) PNG media_image1.png 780 1012 media_image1.png Greyscale comprising a rigid material (NOTE: as the upper and lower portions 536 and 534 are a solid structure it is implied that they have some degree of rigidity) and having a proximal side and a distal side (annotated Fig. 40), wherein the proximal side of the distal shell is adapted to be arranged closer to the center of the anatomical structure ([0068], 615 contacts the skin and the proximal side of the distal shell is arranged closer to 615 and is thus is adapted to be arranged closer to the center of the anatomical structure than the distal side), - a compressible structure (682, 684, 686, 688) ([0078], padding sets are compressible) having a proximal side (annotated Fig. 40 above, Fig. 41, [0068] side closer to 615 which contacts the skin) and a distal side (annotated Fig. 40 , above, [0068] side further from 615 which contacts the skin) and comprising a first region (annotated Fig. 40 above), the compressible structure being elastically and non-permanently deformable in a height direction normal to the proximal side of the distal shell ([0072],the pads have spring rates and are thus elastic and capable of being elastically and non-permanently deformable; [0071], the pad is compressed against the user’s body; [0078]; NOTE: normal is interpreted as perpendicular and the compressible structure is elastically and non-permanently deformable [compressed] in a height direction that is perpendicular to a portion or tangent of the proximal side of the distal shell, annotated Fig. 40), and the compressible structure being arranged proximal to the distal shell (annotated Fig. 40), - a plurality of elongated members (621) ([0071], stems 621 of pads 611) including a first elongated member (Fig. 40 and Fig. 41 show a plurality of contact portions 615 of pads with elongated members 621 and annotated Fig. 37 below shows a first elongated member), PNG media_image2.png 746 745 media_image2.png Greyscale o wherein the first elongated member extends between a first primary point and a first secondary point in the height direction (annotated Fig. 37 above), o wherein the first primary point is arranged at and travels along with the proximal side of the compressible structure within the first region of the compressible structure ([0071], [0078]; NOTE: as the stem is attached to the contact portion 615 of the pad 611 it would travel along [move with] the proximal side of the compressible structure within the first region of the compressible structure, annotated Fig. 40 above), o wherein the first secondary point of the first elongated member is in a primary position relative to the distal shell when the first region of the compressible structure is in a non-compressed state ([0071]; [0078], annotated Fig. 37 above; when the pad 611 is not compressed the first secondary point is in a position relative to the distal shell which is a primary position), and wherein the first secondary point is in a secondary position relative to the distal shell when the first region of the compressible structure is in a compressed state ([0071]; [0078], Fig. 38, when the pad 611 is compressed the pad 611 including the stem 621 is compressed and the first secondary point of the stem moves relative to the distal shell so the first secondary point is in a different/secondary position relative to the distal shell), o wherein the first elongated member extends at least partly through the compressible structure ([0078], connectors releasably connect the padding sets 682, 684, 686, 688 to fenestrations or other features…The connectors can be tubular structures that allow air to pass from the outer portion of the brace through the pads 611 to the limb of the patient; NOTE: thus the tubular structures are connected to the pads 611 and thus connected to the elongated members 621 of the pads and thus the tubes are considered to be a part of the elongated members and pads 611 and the tubes pass through the compressible structure [padding sets 682, 684, 686, 688]), wherein the first brace part comprises a locking mechanism (531, 533) ([0077]; NOTE: per 112f analysis above a locking mechanism includes a hinge and 533 is a hinge), wherein the locking mechanism, in a locked state, prevents movement between the first secondary point of the first elongated member and the distal shell ([0072],the pads have spring rates and are thus elastic and capable of being elastically and non-permanently deformable; [0077]; [0071]; [0078]; in a completely compressed state of the pads 611, the pads are clamped between the arm of the user and the distal shell and thus cannot move relative to the distal shell; [0072]; [0077]; [0071]; [0078], If the locking mechanism 531, 533 is unlocked the shell could be expanded and the pads can move again, so the locking mechanism in a locked state can prevent movement between the first secondary point of the first elongated member and the distal shell; capable of intended use). Summit in an embodiment of Figs. 40-41 does not explicitly disclose 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. Summit in an embodiment of Figs. 15-16 teaches an analogous brace (930) for management of an anatomical structure ([0054]) comprising a primary anatomical structure (e.g. arm), a secondary anatomical structure (e.g. hand), and a joint (e.g. wrist) and/or an injury between the primary anatomical structure and the secondary anatomical structure (Fig. 15-16), the brace comprising a first brace part (924) extending from a first primary brace part end (annotated Fig. 16) PNG media_image3.png 823 895 media_image3.png Greyscale to a first secondary brace part end (annotated Fig. 16 above) and being adapted to be positioned to cover a first part of the anatomical structure extending over the joint and/or injury (Fig. 16) such that the first primary brace part end is located on the primary anatomical structure (e.g. arm, annotated Fig. 16 above) and the first secondary brace part end is located on the secondary anatomical structure (e.g. wrist, annotated Fig. 16). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the brace of Summit in an embodiment of Figs. 40-41 is 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, as taught by Summit in an embodiment of Figs. 15-16, in order to provide an improved brace that can have several modular adjustable brace sections (Summit, [0056]). Regarding claim 17, Summit as combined discloses the invention as described above with regard to claim 16. Summit further discloses wherein the distal shell comprises a plurality of openings ([0078], The connectors can be tubular structures that allow air to pass from the outer portion of the brace through the pads 611 to the limb of the patient. NOTE: thus there are openings in which the tubular structures are disposed that pass through the distal shell and the compressible structure as seen in Fig. 40), including a first opening (see in Fig. 40 where tube 687 is disposed is an opening), and wherein the first elongated member is configured to extend through the first opening ([0078], connectors releasably connect the padding sets 682, 684, 686, 688 to fenestrations or other features…The connectors can be tubular structures that allow air to pass from the outer portion of the brace through the pads 611 to the limb of the patient; NOTE: thus the tubular structures are connected to the pads 611 and thus connected to the elongated members 621 of the pads and thus the tubes are considered to be a part of the elongated members and pads 611 and the tubes pass through the compressible structure and distal shell and thus pass through the openings of the distal shell). Regarding claim 18, Summit as combined discloses the invention as described above with regard to claim 16. Summit further discloses wherein the plurality of elongated members includes a second elongated member ([0071], stems 621 of pads 611; NOTE: each pad 611 has an elongated member thus there is a second elongated member 621; see annotated Fig. 37 above with regard to the rejection to claim 16 showing a stem of an elongated member that each elongated member has), - wherein the second elongated member extends between a second primary point and a second secondary point in the height direction (see annotated Fig. 37 with regard to the claim 16 rejection where the first primary and secondary points are shown and these locations of points on the second elongated member would be a second primary point and a second secondary point), - wherein the second primary point is arranged at and travels along with the proximal side of the compressible structure within a second region of the compressible structure ([0071], [0078]; NOTE: as the second stem [second elongated member] is attached to the contact portion 615 of the second pad 611 it would travel along [move with] the proximal side of the compressible structure within a second region of the compressible structure, annotated Fig. 40 above), - wherein the second secondary point of the second elongated member is in a primary position relative to the distal shell when the second region of the compressible structure is in a non-compressed state ([0071]; [0078], annotated Fig. 37 above; when the pad 611 is not compressed the second secondary point is in a position relative to the distal shell which is a primary position), and wherein the second secondary point is in a secondary position relative to the distal shell when the second region of the compressible structure is in a compressed state ([0071]; [0078], Fig. 38, when the second pad 611 the pad 611 including the stem 621 is compressed and the second secondary point of the stem moves relative to the distal shell so the second secondary point is in a different/secondary position relative to the distal shell), wherein the locking mechanism, in the locked state, prevents movement between the second secondary point of the second elongated member and the distal shell ([0072]]; [0077]; [0071]; [0078]; in a completely compressed state of the pads 611, the pads are clamped between the arm of the user and the distal shell and thus cannot move relative to the distal shell; [0072]; [0077]; [0071]; [0078, If the locking mechanism 531, 533 is unlocked the shell could be expanded and the pads can move again, so the locking mechanism in a locked state can prevent movement between the second secondary point of the second elongated member and the distal shell; capable of intended use). Regarding claim 19, Summit as combined discloses the invention as described above with regard to claim 16. Summit further discloses wherein the compressible structure comprises at least one lattice structure ([0078], the padding sets 682, 684, 686, 688 can also include additional fenestrations to improve ventilations and thus would resemble a lattice design; NOTE: lattice is defined as a network or design resembling a lattice, merriamwebster.com, and a pad with fenestrations throughout would resemble a lattice). Regarding claim 20, Summit as combined discloses the invention as described above with regard to claim 16. Summit further discloses wherein the compressible structure is configured to be reversibly compressible ([0072], the pads have spring rates and are thus elastic and capable of being elastically and non-permanently deformable and thus reversibly compressible) between the non-compressed state and the compressed state a plurality of times, such as at least 10 times ([0072], [0077], The brace can have an upper portion 536 that is coupled to a lower portion 534 by a hinge 533 on one edge and an adjustable coupling 531 on the opposite edge; NOTE: with an adjustable coupling the brace is adjustably fastened and where the brace is unfastened the compression of the pads 611 would be reversed and this is capable of occurring a plurality of times; capable of intended use). Regarding claim 25, Summit, in an embodiment of Figs. 40-41, discloses method for manufacturing a brace for management of an anatomical structure ([0077] to [0082]) the method comprising: - providing a distal shell (534, 536) (shell is distal to user relative to the pad; annotated Fig. 40 above with regard to claim 16) for a first brace part (932) ([0056], adjustable and modular sections can be secured), the distal shell comprising a rigid material (NOTE: as the upper and lower portions 536 and 534 are a solid structure it is implied that they have some degree of rigidity) and having a proximal side and a distal side (annotated Fig. 40 above with regard to claim 16), wherein the proximal side of the distal shell is adapted to be arranged closer to the center of the anatomical structure ([0068], 615 contacts the skin and the proximal side of the distal shell is arranged closer to 615 and is thus is adapted to be arranged closer to the center of the anatomical structure than the distal side), - providing a compressible structure (682, 684, 686, 688) ([0078], padding sets are compressible as the pads 611 are compressible) and a plurality of elongated members (621) ([0071], stems 621 of pads 611), o the compressible structure having a proximal side (annotated Fig. 40 above with regard to claim 16, Fig. 41, [0068] side closer to 615 which contacts the skin) and a distal side (annotated Fig. 40 , above, [0068] side further from 615 which contacts the skin) and comprising a first region (annotated Fig. 40 above with regard to claim 16), the compressible structure being elastically and non-permanently deformable ([0071], the pad is compressed against the user’s body; [0072]; [0078]; NOTE: the pads have spring rates and are thus elastic and capable of being elastically and non-permanently deformable as the pad is compressible and expandable it is elastically and non-permanently deformable) , o the plurality of elongated members includes a first elongated member (Fig. 40 and Fig. 41 show a plurality of contact portions 615 of pads with elongated members 621 and annotated Fig. 37 above with regard to claim 16 shows a first elongated member), wherein the first elongated member extends between a first primary point and a first secondary point in the height direction (annotated Fig. 37 above with regard to claim 16), - arranging the compressible structure and the plurality of elongated members ([0071]; [0078]; Figs. 40-41; Figs. 37-39), o such that the compressible structure is arranged proximal to the distal shell (annotated Fig. 40 above with regard to claim 16), and the compressible structure being elastically and non-permanently deformable (in a height direction normal to the proximal side of the distal shell ([0071], the pad is compressed against the user’s body; [0072], the pads have spring rates and are thus elastic and capable of being elastically and non-permanently deformable; [0078]; NOTE: normal is interpreted as perpendicular and the compressible structure is elastically and non-permanently deformable [compressed] in a height direction that is perpendicular to a portion or tangent of the proximal side of the distal shell, annotated Fig. 40), o such that the first primary point of the first elongated member is arranged at, and travels along with, the proximal side of the compressible structure within the first region of the compressible structure ([0071], [0078]; NOTE: as the stem is attached to the contact portion 615 of the pad 611 it would travel along [move with] the proximal side of the compressible structure within the first region of the compressible structure, annotated Fig. 40 above), o such that the first secondary point of the first elongated member is in a primary position relative to the distal shell when the first region of the compressible structure is in a non-compressed state ([0071]; [0078], annotated Fig. 37 above; when the pad 611 is not compressed the first secondary point is in a position relative to the distal shell which is a primary position), o such that the first secondary point of the first elongated member is in a secondary position relative to the distal shell when first region of the compressible structure is in a compressed state ([0071]; [0078], Fig. 38, when the pad 611 is compressed the pad 611 including the stem 621 is compressed and the first secondary point of the stem moves relative to the distal shell so the first secondary point is in a different/secondary position relative to the distal shell), o such that the first elongated member extends at least partly through the compressible structure ([0078], connectors releasably connect the padding sets 682, 684, 686, 688 to fenestrations or other features…The connectors can be tubular structures that allow air to pass from the outer portion of the brace through the pads 611 to the limb of the patient; NOTE: thus the tubular structures are connected to the pads 611 and thus connected to the elongated members 621 of the pads and thus the tubes are considered to be a part of the elongated members and pads 611 and the tubes pass through the compressible structure [padding sets 682, 684, 686, 688]). - providing a locking mechanism (531, 533) ([0077]; NOTE: per 112f analysis above a locking mechanism includes a hinge and 533 is a hinge) for the first brace part (Fig. 40), wherein the locking mechanism, in a locked state, prevents movement between the first secondary point of the first elongated member and the distal shell ([0077]; [0071]; [0078]; in a completely compressed state of the pads 611, the pads are clamped between the arm of the user and the distal shell and thus cannot move relative to the distal shell. If the locking mechanism 531, 533 is unlocked the shell could be expanded and the pads can move again, so the locking mechanism in a locked state can prevent movement between the first secondary point of the first elongated member and the distal shell; capable of intended use). Summit does not disclose in an embodiment of Figs. 40-41, method for manufacturing 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. Summit in an embodiment of Figs. 15-16 teaches an analogous method for manufacturing a brace for management of an anatomical structure (e.g. arm) (Fig. 15-16) ([0046]) comprising a primary anatomical structure, a secondary anatomical structure (e.g. hand), and a joint (e.g. wrist) and/or an injury between the primary anatomical structure and the secondary anatomical structure (Fig. 15-16). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the method for manufacturing a brace for management of an anatomical structure of Summit in an embodiment of Figs. 40-41, is a method for manufacturing 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, as taught by Summit in an embodiment of Figs. 15-16, in order to provide an improved method that facilitates manufacturing a brace with a plurality of accessible regions (Summit, [0054], and a brace that can have several modular adjustable brace sections (Summit, [0056]). Regarding claim 26, Summit as combined discloses the invention as described above with regard to claim 25. Summit further discloses wherein providing the compressible structure comprises manufacturing the compressible structure using additive manufacturing ([0062]; [0079]), such as 3D printing ([0079]; NOTE: limitation interpreted under 112b above as exemplary). Regarding claim 27, Summit as combined discloses the invention as described above with regard to claim 25. Summit further discloses wherein providing the compressible structure and the plurality of elongated members comprises manufacturing the compressible structure and the plurality of elongated members in a simultaneous additive manufacturing process ([0062]; [0079]), such as a 3D printing process ([0079]; NOTE: limitation interpreted under 112b above as exemplary). Regarding claim 30, Summit as combined discloses the invention as described above with regard to claim 25. Summit further discloses providing a second brace part (904) substantially similar to the first brace part (see analysis above with regard to 112b rejection) and attaching the first brace part and the second brace part (940) ([0056]; Fig. 17). Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 16-22 and 25-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-20 of copending Application No. 19/144,691 in view of Summit (US 2011/0301520) (“the reference patent application”). Regarding claim 16, the limitations therein are recited in claim 11 of the reference patent application including a cast for management of an anatomical structure, the cast comprising a first cast part extending from a first primary cast part end to a first secondary cast part end and being adapted to be positioned to cover a first part of the anatomical structure, the first cast part comprising:- a distal shell comprising a rigid material and having a proximal side and a distal side,- a compressible structure having a proximal side and a distal side and comprising a first region, the compressible structure being elastically and non-permanently deformable in a height direction normal to the proximal side of the distal shell, and the compressible structure being arranged proximal to the distal shell,- a plurality of elongated members including a first elongated member, wherein the first elongated member extends between a first primary point and a first secondary point in the height direction, wherein the first primary point is arranged at and travels along with the proximal side of the compressible structure within the first region of the compressible structure, wherein the first secondary point of the first elongated member is in a primary position relative to the distal shell when the first region of the compressible structure is in a non-compressed state, and wherein the first secondary point is in a secondary position relative to the distal shell when the first region of the compressible structure is in a compressed state, wherein the first cast part comprises a locking mechanism, wherein the locking mechanism, in a locked state, prevents movement between the first secondary point of the first elongated member and the distal shell. Claim 11 of the reference patent application does not disclose that the cast is a brace, 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, wherein the proximal side of the distal shell is adapted to be arranged closer to the center of the anatomical structure, wherein the first elongated member extends at least partly through the compressible structure. Summit teaches a brace (930) (Figs. 15-16) ([0010];[0025]; custom designed and adjustable cast or brace) for management of an anatomical structure comprising a primary anatomical structure (e.g. arm), a secondary anatomical structure (e.g. hand), and a joint (e.g. wrist) and/or an injury between the primary anatomical structure and the secondary anatomical structure (Fig. 15-16), the brace comprising a first brace part (924) extending from a first primary brace part end (annotated Fig. 16 with regard to the rejection to claim 16 above) to a first secondary brace part end (annotated Fig. 16 above) and being adapted to be positioned to cover a first part of the anatomical structure extending over the joint and/or injury (Fig. 16) such that the first primary brace part end is located on the primary anatomical structure (e.g. arm, annotated Fig. 16 above) and the first secondary brace part end is located on the secondary anatomical structure (e.g. wrist, annotated Fig. 16), the first brace part comprises:- a distal shell (534, 536) (annotated Fig. 40 above with regard to claim 16) comprising a rigid material (NOTE: as the upper and lower portions 536 and 534 are solid it is implied that they have some degree of rigidity) and having a proximal side and a distal side (annotated Fig. 40), wherein the proximal side of the distal shell is adapted to be arranged closer to the center of the anatomical structure ([0068], 615 contacts the skin and the proximal side of the distal shell is arranged closer to 615 and is thus is adapted to be arranged closer to the center of the anatomical structure than the distal side), - a compressible structure (682, 684, 686, 688) ([0078], padding sets are compressible) having a proximal side (annotated Fig. 40 above, Fig. 41, [0068] side closer to 615 which contacts the skin) and a distal side (annotated Fig. 40 , above, [0068] side further from 615 which contacts the skin) and comprising a first region (annotated Fig. 40 above), the compressible structure being elastically and non-permanently deformable in a height direction normal to the proximal side of the distal shell ([0071], the pad is compressed against the user’s body; [0078]; NOTE: normal is interpreted as perpendicular and the compressible structure is elastically and non-permanently deformable [compressed] in a height direction that is perpendicular to a portion or tangent of the proximal side of the distal shell, annotated Fig. 40), and the compressible structure being arranged proximal to the distal shell (annotated Fig. 40), - a plurality of elongated members (621) ([0071], stems 621 of pads 611) including a first elongated member (Fig. 40 and Fig. 41 show a plurality of contact portions 615 of pads with elongated members 621 and annotated Fig. 3 above with regard to claim 16 shows a first elongated member), o wherein the first elongated member extends between a first primary point and a first secondary point in the height direction (annotated Fig. 37 above), o wherein the first primary point is arranged at and travels along with the proximal side of the compressible structure within the first region of the compressible structure ([0071], [0078]; NOTE: as the stem is attached to the contact portion 615 of the pad 611 it would travel along [move with] the proximal side of the compressible structure within the first region of the compressible structure, annotated Fig. 40 above), o wherein the first secondary point of the first elongated member is in a primary position relative to the distal shell when the first region of the compressible structure is in a non-compressed state ([0071]; [0078], annotated Fig. 37 above; when the pad 611 is not compressed the first secondary point is in a position relative to the distal shell which is a primary position), and wherein the first secondary point is in a secondary position relative to the distal shell when the first region of the compressible structure is in a compressed state ([0071]; [0078], Fig. 38, when the pad 611 is compressed the pad 611 including the stem 621 is compressed and the first secondary point of the stem moves relative to the distal shell so the first secondary point is in a different/secondary position relative to the distal shell), o wherein the first elongated member extends at least partly through the compressible structure ([0078], connectors releasably connect the padding sets 682, 684, 686, 688 to fenestrations or other features…The connectors can be tubular structures that allow air to pass from the outer portion of the brace through the pads 611 to the limb of the patient; NOTE: thus the tubular structures are connected to the pads 611 and thus connected to the elongated members 621 of the pads and thus the tubes are considered to be a part of the elongated members and pads 611 and the tubes pass through the compressible structure [padding sets 682, 684, 686, 688]), wherein the first brace part comprises a locking mechanism (531, 533) ([0077]; NOTE: per 112f analysis above a locking mechanism includes a hinge and 533 is a hinge). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the cast of the device of the reference patent application of claim 1 is a brace, as taught by Summit, and that the brace is 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, wherein the proximal side of the distal shell is adapted to be arranged closer to the center of the anatomical structure, wherein the first elongated member extends at least partly through the compressible structure, as taught by Summit in order to provide an improved device that is useful for a broken limb (Summit, [0055]) and that can be a modular design and in which fitted regions within the walls of the cast and an array of surface pads of progressive thickness can be produced with the initial case (Summit, [0059] to [0062]) ands as Summit discloses a cast or brace can be designed (Summit, [0010]). Regarding claim 17, the limitations therein are substantially recited in claim 12 of the reference patent application Regarding claim 18, the limitations therein are substantially recited in claim 12 of the reference patent application in view of Summit. Summit further teaches wherein the plurality of elongated members includes a second elongated member ([0071], stems 621 of pads 611; NOTE: each pad 611 has an elongated member thus there is a second elongated member 621; see annotated Fig. 37 above with regard to the rejection to claim 16 showing a stem of an elongated member that each elongated member has), - wherein the second elongated member extends between a second primary point and a second secondary point in the height direction (see annotated Fig. 37 with regard to the claim 16 rejection where the first primary and secondary points are shown and these locations of points on the second elongated member would be a second primary point and a second secondary point), - wherein the second primary point is arranged at and travels along with the proximal side of the compressible structure within a second region of the compressible structure ([0071], [0078]; NOTE: as the second stem [second elongated member] is attached to the contact portion 615 of the second pad 611 it would travel along [move with] the proximal side of the compressible structure within a second region of the compressible structure, annotated Fig. 40 above), - wherein the second secondary point of the second elongated member is in a primary position relative to the distal shell when the second region of the compressible structure is in a non-compressed state ([0071]; [0078], annotated Fig. 37 above; when the pad 611 is not compressed the second secondary point is in a position relative to the distal shell which is a primary position), and wherein the second secondary point is in a secondary position relative to the distal shell when the second region of the compressible structure is in a compressed state ([0071]; [0078], Fig. 38, when the second pad 611 the pad 611 including the stem 621 is compressed and the second secondary point of the stem moves relative to the distal shell so the second secondary point is in a different/secondary position relative to the distal shell), wherein the locking mechanism, in the locked state, prevents movement between the second secondary point of the second elongated member and the distal shell ([0077]; [0071]; [0078]; in a completely compressed state of the pads 611, the pads are clamped between the arm of the user and the distal shell and thus cannot move relative to the distal shell. If the locking mechanism 531, 533 is unlocked the shell could be expanded and the pads can move again, so the locking mechanism in a locked state can prevent movement between the second secondary point of the second elongated member and the distal shell; capable of intended use). Regarding claim 19, the limitations therein are substantially recited in claim 13 of the reference patent application. Regarding claim 20, the limitations therein are substantially recited in claim 12 of the reference patent application in view of Summit. Summit further teaches wherein the compressible structure is configured to be reversibly compressible between the non-compressed state and the compressed state a plurality of times, such as at least 10 times ([0077], The brace can have an upper portion 536 that is coupled to a lower portion 534 by a hinge 533 on one edge and an adjustable coupling 531 on the opposite edge; NOTE: with an adjustable coupling the brace is adjustably fastened and where the brace is unfastened the compression of the pads 611 would be reversed and this is capable of occurring a plurality of times; capable of intended use). Regarding claim 21, the limitations therein are substantially recited in claim 14 of the reference patent application. Regarding claim 22, the limitations therein are substantially recited in claim 15 of the reference patent application. Regarding claim 25, claim 16 of the reference patent application discloses a method for manufacturing a cast for management of an anatomical structure, the method comprising:- providing a distal shell for a first cast part, the distal shell comprising a rigid material and having a proximal side and a distal side,- providing a compressible structure and a plurality of elongated members, the compressible structure having a proximal side and a distal side and comprising a first region, the compressible structure being elastically and non- permanently deformable, the plurality of elongated members includes a first elongated member, wherein the first elongated member extends between a first primary point and a first secondary point in the height direction, - arranging the compressible structure and the plurality of elongated members, such that the compressible structure is arranged proximal to the distal shell, and the compressible structure being elastically and non-permanently deformable in a height direction normal to the proximal side of the distal shell, such that the first primary point of the first elongated member is arranged at, and travels along with, the proximal side of the compressible structure within the first region of the compressible structure, such that the first secondary point of the first elongated member is in a primary position relative to the distal shell when the first region of the compressible structure is in a non-compressed state, and such that the first secondary point of the first elongated member is in a secondary position relative to the distal shell when first region of the compressible structure is in a compressed state, - providing a locking mechanism for the first cast part, wherein the locking mechanism, in a locked state, prevents movement between the first secondary point of the first elongated member and the distal shell. Claim 16 of the reference application does not disclose a method for manufacturing 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 method comprising:- providing a distal shell for a first brace part, the distal shell comprising a rigid material and having a proximal side and a distal side, wherein the proximal side of the distal shell is adapted to be arranged closer to the center of the anatomical structure. Summit further teaches method for manufacturing a brace (930) ([0025]; custom designed and adjustable cast or brace) for management of an anatomical structure (e.g. arm) (Fig. 15-16) ([0046]) comprising a primary anatomical structure, a secondary anatomical structure (e.g. hand), and a joint (e.g. wrist) and/or an injury between the primary anatomical structure and the secondary anatomical structure (Fig. 15-16), the method comprising: - providing a distal shell (534, 536) (annotated Fig. 40 above with regard to claim 16) for a first brace part (932) ([0056], adjustable and modular sections can be secured), the distal shell comprising a rigid material (NOTE: as the upper and lower portions 536 and 534 are solid it is implied that they have some degree of rigidity) and having a proximal side and a distal side (annotated Fig. 40 above with regard to claim 16), wherein the proximal side of the distal shell is adapted to be arranged closer to the center of the anatomical structure ([0068], 615 contacts the skin and the proximal side of the distal shell is arranged closer to 615 and is thus is adapted to be arranged closer to the center of the anatomical structure than the distal side). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the method of manufacturing a cast for management of an anatomical structure of the reference patent application claim 1, is a method for manufacturing a brace, as taught by Summit and that the method is 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 method comprising:- providing a distal shell for a first brace part, the distal shell comprising a rigid material and having a proximal side and a distal side, wherein the proximal side of the distal shell is adapted to be arranged closer to the center of the anatomical structure, as taught by Summit, in order to provide an improved method that produces a method that is useful for a broken limb (Summit, [0055]) and that produces a device that can be a modular design and in which fitted regions within the walls of the cast and an array of surface pads of progressive thickness can be produced with the initial case (Summit, [0059] to [0062]) and as Summit discloses a method of manufacturing a brace or a cast (Summit, [0010]). Regarding claim 26, the limitations therein are substantially recited in claim 17 of the reference patent application. Regarding claim 27, the limitations therein are substantially recited in claim 18 of the reference patent application. Regarding claim 28, the limitations therein are substantially recited in claim 19 of the reference patent application. Regarding claim 29, the limitations therein are substantially recited in claim 20 of the reference patent application. Regarding claim 30, the limitations therein are substantially recited in claim 18 of the reference patent application in view of Summit. Summit further teaches providing a second brace part (904) substantially similar to the first brace part (see analysis above with regard to 112b rejection) and attaching the first brace part and the second brace part (940) ([0056]; Fig. 17). Allowable Subject Matter Claims 28-29 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 and contingent upon pertinent rejections and objections being overcome and the double patenting rejection being overcome. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to GINA MCCARTHY whose telephone number is (408)918-7594. The examiner can normally be reached Monday - Friday, 7:00-3:30 PT. 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, Alireza Nia can be reached at 571-270-3076. 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. /G.M./ Examiner, Art Unit 3786 /OPHELIA A HAWTHORNE/ Primary Examiner, Art Unit 3786