DETAILED ACTION
In the preliminary amendment filed 7/17/25, Applicant has amended claims 1-7; amended the specification; submitted a replacement abstract; and submitted replacement drawing sheets. Currently, claims 1-7 are 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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
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 it includes legal phraseology (i.e. “comprises” and in line 3, “the inner shell that is removably connected to the outer shell” should be amended to recite “the inner shell is removably connected to the outer shell”. 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).
Drawings
The drawings were received on 7/17/25. These drawings are acceptable.
Claim Objections
Claims 1, 5 and 6 are objected to because of the following informalities which require appropriate correction:
Claim 1 includes multiple minor informalities and it is suggested that the claim be amended as follows for improved clarity and readability:
A cranial remodeling orthosis comprising an outer shell and an inner shell, wherein the inner wall of the outer shell defines an inner cavity of the outer shell for insertion of the head of a wearer, wherein the inner shell is removably connected to the outer shell and defines a reduced inner cavity for insertion of the head of the wearer, which has a smaller volume than the inner cavity of the outer shell, wherein the reduced inner cavity corresponds to a certain intermediate stage of growth between an initial outer shape of the head of the wearer and a target outer shape of the head of the wearer, and wherein the inner shell is removably connected to the outer shell in at least two different places distributed around a margin of the inner shell.
In claims 5 and 6: “3D” should be amended to recite “three dimensional”.
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 1-7 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.
Claim 1 recites the limitation "the inner wall" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the surface" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-5 and 7 each depend directly or indirectly from a rejected claim and, therefore, contain the same deficiencies as the claims from which they depend.
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.
Claim(s) 1-7 are 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).
Specifically, Claims 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Claim 1 positively recites part of the human body in combination with the device, as for example: in claim 1, the limitation reciting “…the reduced inner cavity corresponds to a certain intermediate stage of growth…of the wearer’s head…” of the claim encompasses a human being. It has been held that a claim directed to or including within its scope, a human being will not be considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the constitution. Accordingly, proper procedure where a claim is directed to an apparatus “attached to” the human body or any part thereof is to reject such claim under 35 U.S.C 101 with an explanation that, because the claim positively recites a part of the human body, it is directed to nonstatutory subject matter. See Animals – Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987). Therefore, for at least this reason, claim 1 has been rejected under 35 USC 101. It is suggested that claim 1 be amended to recite that “…the reduced inner cavity is configured to correspond to a certain intermediate stage of growth…” in order to overcome this deficiency.
Claims 2-7 each depend directly or indirectly from a rejected claim and, therefore, contain the same deficiencies as the claims from which they depend.
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Mottram et al (CA-2996246-A1) in view of Huang (CN-217448164-U).
With respect to claim 1, Mottram discloses a cranial remodeling orthosis (orthosis 10 in figs 1A-1C; see abstract) comprising an outer shell (outer layer 20; fig 1A-C) and an inner shell (mesh layer 30; fig 1A-C), wherein the inner wall of the outer shell (surface of layer 20 that faces and is adjacent to layer 30) defines an inner cavity of the outer shell for insertion of the wearer's head (orthosis 10 is shaped to surround a substantial portion of the head of a wearer – para [70]; the interior of the orthosis is an open cavity as shown in fig 1A-C and accommodates the head during use), wherein the inner shell (30) is removably connected to the outer shell (the mesh layer and the outer layer are secured together by one or more of hook and loop fastener material, click lock attachments or pin and hole type fastenings – para [29]) and defines a reduced inner cavity for insertion of the wearer's head, which has a smaller volume than the inner cavity of the outer shell (as shown in figs 1A-C, layer 30 is located on the interior of layer 20 and thus fits inside the cavity defined by layer 20 and inherently defines an interior cavity having a reduced size and smaller volume as compared to that of layer 20; see fig 1A and 1C), wherein the reduced inner cavity corresponds to a certain intermediate stage of growth between an initial outer shape of the wearer's head and a target outer shape of the wearer's head (para [34]).
Although Mottram discloses that the inner shell (mesh layer) and the outer shell (outer layer) are secured together by one or more of hook and loop fastener material, click lock attachments or pin and hole type fastenings (para [29]), there is no explicit disclosure that the inner shell is removably connected to the outer shell in at least two different places distributed around a margin of the inner shell.
Huang, however, teaches an analogous cranial remodeling orthosis (translation pgs 1 and 4; orthosis 100 in fig 1;) comprising an outer shell (shell 3; fig 1; translation pg 4) and an inner shell (sheet 1; fig 1; translation pg 4) wherein the inner shell (1) is removably connected to the outer shell (3) in at least two different places distributed around a margin of the inner shell (detachably connected via connection between protrusion 12 and through hole 32 – translation pg 6; there is a second protrusion 121 and through hole 321 on the opposite side of the orthosis thus providing attachment at two different locations around a margin of sheet 1- see figs 3 and 6). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the orthosis of Mottram so that the inner shell is removably connected to the outer shell in at least two different places distributed around a margin of the inner shell, as taught by Huang, in order to provide more secure attachment between the inner and outer shell layers to prevent unwanted sliding or displacement between the layers during use.
With respect to claim 2, Mottram in view of Huang discloses the orthosis substantially as claimed (see rejection of claim 1) and Mottram also discloses that the inner shell is removably connected to the inner wall of the outer shell (the mesh layer and the outer layer are secured together by one or more of hook and loop fastener material, click lock attachments or pin and hole type fastenings – para [29]; as shown in figs 1A-C, layer 30 is located on the interior of layer 20 and thus is connected to the inner wall of layer 20).
With respect to claim 3, Mottram in view of Huang discloses the orthosis substantially as claimed (see rejection of claim 1) and Mottram also discloses in an alternative embodiment that the cranial remodeling orthosis can be a part of an assembly of the cranial remodeling orthosis (orthosis 210; fig 9-10) that further comprises at least one other inner shell (liner 270 – figs 9-10) for removable connection to the outer shell (the liner is attachable and detachable from the orthosis – para [93]) defining a different reduced inner cavity having a different volume (as shown in fig 9, layer 270 is located on the interior of the mesh layer and thus fits inside the cavity defined by mesh layer and inherently defines an interior cavity having a reduced size and smaller volume as compared to that of the mesh layer; the smaller size/volume is thus “different” from that of the mesh layer). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the orthosis of Mottram in view of Huang to further include at least one other inner shell for removable connection to the outer shell defining a different reduced inner cavity having a different volume, as taught in the embodiment of figures 9-10 of Mottram, in order to increase comfort, prevent rotation of the orthosis, and transfer moisture away from the wearer’s head (Mottram para [91-92]).
With respect to claim 4, Mottram in view of Huang discloses the orthosis substantially as claimed (see rejection of claim 1) and Mottram also discloses that the inner shell comprises a perforated surface of the inner shell (layer 30 is a “mesh” and is formed from a plurality of body elements and a plurality of openings defined by the body elements – para [11]).
With respect to claim 5, Mottram in view of Huang discloses the orthosis substantially as claimed (see rejection of claim 4) and Mottram also discloses that the inner shell is made of a 3D printed material (para [27-29]).
With respect to claim 6, Mottram in view of Huang discloses the orthosis substantially as claimed (see rejection of claim 5) and Mottram also discloses that the inner shell further comprises a mesh 3D structure between the surface of the inner shell and the inner wall of the outer shell (para [27-29]; location of layer 30 comprising the mesh structure adjacent to the inner wall of layer 20 is shown in figs 1A-C).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mottram et al (CA-2996246-A1) in view of Huang (CN-217448164-U) and further in view of Allen (US 2008/0045871).
With respect to claim 7, Mottram in view of Huang discloses the orthosis substantially as claimed (see rejection of claim 1). However, although Mottram discloses that the inner shell (mesh layer) and the outer shell (outer layer) are removably connected together by one or more of hook and loop fastener material, click lock attachments or pin and hole type fastenings (para [29]), there is no explicit disclosure that the inner shell is removably connected to the outer shell along most of the margin of the inner shell.
Allen, however, teaches an analogous orthosis which includes pin (16) and hole (26) type fasteners for removably connecting inner and outer shells (inner layer 12 is attached to piece 14; para [0025]; see figs 1 and 2C) wherein the pins 16 are distributed across almost the entire outer surface of layer 12 to cooperate with holes 26 distributed across almost the entire surface of piece 14 to thereby permit connection between layer 12 and piece 14 along most of the margin of layer 12 (see figs 1 and 2C). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the orthosis of Mottram in view of Huang so that the inner shell is removably connected to the outer shell along most of the margin of the inner shell, as taught by Allen, in order to further secure the attachment between the inner and outer shell layers to prevent unwanted sliding or displacement between the layers during use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786
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