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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/21/2025 has been entered.
Response to Amendment
Applicant’s amendments of claims 1, 3-4, and 21 are acknowledged by the Examiner.
Applicant’s amendments of claims 1, 3-4, and 21 have overcome the previous claim rejections under 35 U.S.C. 112(b). Therefore, the claim rejections under 35 U.S.C. 112(b) are withdrawn.
Claims 1-11 and 21 are pending in the current Application.
Response to Arguments
Applicant's arguments filed 11/21/2025 have been fully considered but they are not persuasive.
In regards to Applicant’s arguments that the limitations “at least one unlined zone consisting of unlined and unpadded space” of claim 1, and “being completely empty space and located directly adjacent to the plurality of ventilation holes” of claim 21, suggesting that these limitations precludes the mesh layer (30) from being located within the rigid shell (20) of Mottram, Examiner respectfully disagrees.
With regards to claim 1, the limitation of “at least one unlined zone consisting of unlined and unpadded space” only requires the unlined zone to consist of the rigid shell be “unlined” (i.e. not having a material placed against the rigid shell), and “unpadded” (i.e. not having a pad placed against the rigid shell). Neither limitation of claim 1 which define an “unlined zone” actually precluding the presence of additional material such as the mesh (30) of Mottram being between the rigid shell (20) of Mottram and the infant’s head. Furthermore, because claim 1 as a whole falls under a comprising statement, claim 1 is open to include additional structures that are unclaimed (see MPEP 2111.03 I; i.e. a material located between the rigid shell and infant’s head like the mesh of Mottram).
With regards to claim 21, “being completely empty space and located directly adjacent to the plurality of ventilation holes” of claim 21 does not overcome the reference of Mottram. Examiner in the previous rejection has defined the unlined zone of 110 as “the portion of 110 in which there exists a void between 30 and 20; see [0080]” (emphasis added). Void, as defined by the Merriam-Webster dictionary definitions 2, 3, and 5 of the term void is as follows: “containing nothing”, “not occupied”, and “being without something specified” (https://www.merriam-webster.com/dictionary/void). Thus, by definition, because Mottram discloses a void between 30 and 20 in [0080], Mottram discloses a space between 30 and 20 which contains nothing, is not occupied, or is without something specified (i.e. an empty space without an engagement between 20 and 30). Therefore, even if 30 is between the user’s head and the shell 20, the void between 20 and 30 defines a portion of 30 which is not placed against 20 and is therefore not “lining” 20 and forms an unlined zone which is completely empty space and located directly adjacent the ventilation holes as claimed.
With regards to Applicant’s arguments that “utilizes a mesh layer (30) that fills the entire inside of the orthosis (10). See FIGS. 3 and 4 and para. [0074]. That is, "the mesh layer 30, shown separately in FIG. 3, is disposed substantially within the outer layer 20, and corresponds substantially in shape to the outer layer." See FIG. 3 below and para. [0074]”. Examiner first notes that substantially is defined by the Merriam-Webster dictionary definition 5 as “being largely but not wholly that which is specified” (see https://www.merriam-webster.com/dictionary/substantial). Examiner asserts that for the mesh layer to “substantially” correspond in shape to the outer layer, only 51% (i.e. a large or majority portion) of the mesh layer is required to correspond in shape (i.e. line the outer shell (20)). Therefore, the disclosure of Mottram paragraph [0074] can be interpreted as 49% of the mesh layer does not correspond in shape to the outer shell to form the void as discussed in [0080] and thereby, forming “an unlined zone” of the outer shell as claimed. Additionally the Examiner notes that figures 3 and 4 do not depict the outer shell (20) overlying the mesh (30) and thus, Applicant cannot reasonably rely upon figures 3 and 4 to evidence that there is not an unlined portion between structures 30 and 20 when 20 is placed over 30.
In regards to Applicant’s argument that Mottram fails to disclose the removal of the mesh layer in certain areas or zones in [0026] and [0086]. Examiner first notes that, paragraph [0026] was not relied upon at all in the final rejection on pages 5-7. Furthermore, as discussed above, claims 1 and 21 do not require “a removal of the mesh” as suggested by Applicant as both claims fall under comprising statements leaving the prior art open to having additional structures, and the “consisting of” limitation only limits the unlined portion of the rigid shell to consist of a portion of the rigid shell which does not have a material or padding contacting (i.e. lining) the rigid shell, and does not exclude the presence of a material located between the shell and infant’s head as argued by Applicant.
Thus, neither claim 1 or 21 are distinguishable over the reference of Mottram and all rejections made in the final rejection under 35 U.S.C. 103 are hereby maintained and updated in view of the amendments made to claims 1, 3-4, and 21.
Claim Objections
Claims 21 is objected to because of the following informalities:
Claim 21 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 6-10, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mottram et al. (US 2019/0015238 A1) (hereinafter Mottram).
In regards to claim 1, Mottram discloses A cranial deformation orthosis device (110; see [0085]; see figure 1a) for a head of an infant (see [0001]), comprising:
a rigid outer shell (20 of 110; see [0073]; see figures 1a and 6a) having an anterior portion (110a; see [0085]; see figure 6a) detachably connected to a posterior portion (110b; see [0085]; detachable via 50, 152 and 154; see [0083] and [0085]), the anterior portion (110a) being shaped and configured to be donned on a forward portion of the head of the infant (see figure 6a that 110a is intended to be put on the anterior of a user’s head (as evidenced by the shape of 110a and opening in 110a for the user’s face)) and the posterior portion (110b) being shaped and configured to be donned on an aft portion of the head of the infant (see figure 6a that 110b is intended to be put on the posterior of the user’s head (as evidenced by the shape of 110b which corresponds to the back of a user’s head)), each of the anterior portion (110a) and the posterior portion (110b) has an outer surface (outer surface as seen in figure 6a) inner surface (inner surface seen in figure 6a); and
at least one lined zone (portion of 110 in which 30 conforms to 20 (see [0074]) and comprises padding 60; see [0086])) having selectively positioned padding (60; see [0086]; see figure 7; while not seen in the embodiment of figure 6a, the embodiment of 6a comprises an outer shell and mesh of which 60 is intended to be placed between (see [0086]); therefore the embodiment of figure 6a is considered to have a similar padding) on the inner surface (see figure 7) and configured to prevent head growth in a region of the head aligned thereunder (see [0018] and [0086]) and at least one unlined zone (portion of 110 in which there exists a void between 30 and 20; see [0080]) consisting of unlined and unpadded space on the inner surface (Void, as defined by the Merriam-Webster dictionary definitions 2, 3, and 5 of the term void is as follows: “containing nothing”, “not occupied”, and “being without something specified” (https://www.merriam-webster.com/dictionary/void); thus, because Mottram discloses a void between 30 and 20 in [0080], by definition, Mottram discloses a zone of 20 in which exists space between 30 and 20 which contains nothing, is not occupied, or is without something specified (i.e. an empty space where 30 does not engage or line 20); furthermore, padding 60 is intended to create pressure on the infants head to prevent growth (See [0086]), while the void is intended to promote growth in the direction of the void (see [0080]), therefore the portion of 110 in which there exists a void between 20 and 30 defines an unlined zone of 20 which is both unlined by 30 and unpadded by 60) and configured to permit head growth in a region of the head aligned thereunder (see [0080]), the at least one unlined zone (portion of 110 with void between 20 and 30) having a plurality of ventilation holes (24 of 110; see [0072]; see figure 6a) extending through the inner surface to the outer surface (see figure 6a) to allow air to reach the head without any obstruction (see figure 7 that 24 allows air to reach the infant’s head with minor obstructions provided by 30; in the instance where there exists a void between 20 and 30, no such obstructions would exist to create said minor obstructions of 24 as 30 is spaced apart from 20 (and therefore 24), thus airflow to the infant’s head would be unobstructed).
Mottram does not disclose at least one lined zone having selectively positioned padding on the inner surface of each of the anterior portion and the posterior portion, and at least one unlined zone being unlined and unpadded on the inner surface of each of the anterior portion and the posterior position.
However, Mottram teaches the use of one or more pads (see [0018] and [0086]) to provide a means to adjust the shape and volume of the orthosis to optimize the effect thereof (see [0086]), and that multiple voids can be provided to allow desired growth (see [0005] in reference to regions (plural) where there is a void to allow desired growth (see [0005]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified each of the anterior portion and the posterior portion of the rigid outer shell as disclosed by Mottram and to have included at least one lined zone having selectively positioned padding on the inner surface of each of the anterior portion and the posterior portion, and at least one unlined zone being unlined and unpadded on the inner surface of each of the anterior portion and the posterior position as taught and evidenced by the one or more pads utilized, and regions where there is a void of the disclosure of Mottram in order to have provided improved anterior and posterior portions of the rigid outer shell that would add the benefit of provide a means to adjust the shape and volume of the orthosis to optimize the (head shaping) effect thereof (see [0086]) and to have provided multiple regions where there is a void to allow desired growth (see [0005]).
Furthermore, such a modification is held to be obvious since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)) (see MPEP 2144.04 VI B). In the instant case a duplication of lined zone with the selectively positioned padding, and the void which defines an unlined and unpadded zone to be positioned on each of the anterior and posterior portions of the outer shell provides the known and expected result of shaping the infant’s head into a desired shape.
In regards to claim 2, Mottram discloses the invention as discussed above.
Mottram further discloses wherein each of the anterior portion (110a) and the posterior portion (110b) are hollow with a void formed between inner and outer surfaces (see figure 6a that 110a and 110b form a void for a user’s head), and wherein the at least one unlined zone (portion of 110a and 110b with void between 20 and 30) is asymmetric (see [0106] in reference to 20 being customized based on the head shape of the user, given that deformations in an infant’s cranial cavity are caused by asymmetries of their head, the 110a and 110b being customized to said deformities are considered to be asymmetric and their associated unlined zones would similarly be asymmetric).
In regards to claim 3, Mottram discloses the invention as discussed above.
Mottram further discloses wherein a size and shape of the at least one lined zone (region of 110a and 110b with 60) is assigned based on data of an exact three-dimensional scan of the head of the infant (see [0029], and [0102]; see figure 13), wherein the selectively positioned padding (60) is configured to apply a direct holding point to the head of the infant so as to prevent further growth of the head in a corresponding head region when cranial deformation orthosis device (110) is worn (see [0030] and [0086]).
In regards to claim 4, Mottram discloses the invention as discussed above.
Mottram further discloses wherein a size and a shape of the at least one unlined zone (portion of 110a and 110b with void between 20 and 30) is assigned based on data of an exact three-dimensional scan of the head of the infant (see [0029], and [0102]).
In regards to claim 6, Mottram discloses the invention as discussed above.
Mottram further discloses wherein in a connected state, an annular opening (22; see [0072]; see figure 6a that 110a and 110b have a contoured upper edge, see figure 1a that 10a and 10b have a similar edge which forms 22; thus when 110a and 110b are connected they are considered to form 22) is formed between adjoining upper contoured edges of the anterior and posterior portions (110a and 11b; see figure 6a).
In regards to claim 7, Mottram discloses the invention as discussed above.
Mottram further discloses wherein in a connected state, a slit is formed between adjoining lateral side edges of the anterior and posterior portions (110a and 110b; see figure 6a and 6b that when connected the two edges of 110a and 110b form a slit (similar to that seen in figure 1b).
In regards to claim 8, Mottram discloses the invention as discussed above.
Mottram further discloses wherein each of the anterior portion (110a) and the posterior portion (110b) comprise:
a pair of lateral edges extended between upper and lower contoured edges (see annotated figure 6a and 6b below); and at least one connector (152 and 154; see [0085]; see figure 6a) positioned integrally on each lateral edge (see figure 6a), each connector (152) of the anterior portion (110a) configured to securely connect with a corresponding connector (154) of the posterior portion (110b; see [0085]).
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In regards to claim 9, Mottram discloses the invention as discussed above.
Mottram further discloses wherein the at least one connector (152) of each lateral edge of the anterior portion (110a) is a tongue protruding orthogonally from the respective lateral edge (see figure 6a and 6b).
In regards to claim 10, Mottram discloses the invention as discussed above.
Mottram further discloses wherein the at least one connector (154) of each lateral edge of the posterior portion (110b) is a receiving groove (see [0085]; figure 6a) formed in the respective lateral edge and configured to prevent shear (152 receiving 154 prevents movement of 110a with respect to 110b and therefore prevents shear) and securely receive a corresponding tongue (152) of the anterior portion (110a; see [0085]).
In regards to claim 21, Mottram discloses A cranial deformation orthosis device (110; see [0085]; see figure 1a) for a head of an infant (see [0001]), comprising:
an outer shell (20 of 110; see [0073]; see figures 1a and 6a) having an anterior portion (110a; see [0085]; see figure 6a) detachably connected to a posterior portion (110b; see [0085]; detachable via 50, 152 and 154; see [0083] and [0085]), the anterior portion (110a) being shaped and configured to be donned on a forward portion of the head of the infant (see figure 6a that 110a is intended to be put on the anterior of a user’s head (as evidenced by the shape of 110a and opening in 110a for the user’s face)) and the posterior portion (110b) being shaped and configured to be donned on an aft portion of the head of the infant (see figure 6a that 110b is intended to be put on the posterior of the user’s head (as evidenced by the shape of 110b which corresponds to the back of a user’s head)), each of the anterior portion (110a) and the posterior portion (110b) has an outer surface (outer surface as seen in figure 6a) an inner surface (inner surface seen in figure 6a), and a plurality of ventilation holes (24 of 110; see [0072]; see figure 6a) extending through the inner surface to the outer surface (see figure 6a); and
at least one lined zone (portion of 110 in which 30 conforms to 20 (see [0074]) and comprises padding 60; see [0086])) having selectively positioned padding (60; see [0086]; see figure 7; while not seen in the embodiment of figure 6a, the embodiment of 6a comprises an outer shell and mesh of which 60 is intended to be placed between (see [0086]); therefore the embodiment of figure 6a is considered to have a similar padding) on the inner surface (see figure 7) and configured to prevent head growth in a region of the head aligned thereunder (see [0018] and [0086]) and at least one unlined zone (portion of 110 in which there exists a void between 30 and 20; see [0080]) being unlined and unpadded on the inner surface (a void by definition defines an unlined zone in which 30 does not line the inner surface of 20 as discussed in the rejection of claim 1; furthermore, 60 is intended to create pressure on the infants head to prevent growth (See [0086]), while the void is intended to promote growth in the direction of the void (see [0080]), therefore the portion of 110 in which there exists a void between 20 and 30 defines an unlined zone of 20 which is both unlined by 30 and unpadded by 60) and configured to permit head growth in a region of the head aligned thereunder (see [0080]), the at least one unlined zone (portion of 110 with void) being completely empty space (the definition of void as discussed above is “containing nothing”, “not occupied”, and “being without something specified”; thus a void between 20 and 30 is “a completely empty space”) and located directly adjacent the plurality of ventilation holes (24 of 110; given the 24 of 110 extends over the entirety of 20, the unlined zone defined by the void between 20 and 30 is located adjacent at least a portion of the plurality of 24 as claimed) to allow air to reach the head without any obstruction (see figure 7 that 24 allows air to reach the infant’s head with minor obstructions provided by 30; in the instance where there exists a void between 20 and 30, no such obstructions would exist to create said minor obstructions of 24 as 30 is spaced apart from 20 (and therefore 24), thus airflow to the infant’s head would be unobstructed).
Mottram does not disclose at least one lined zone having selectively positioned padding on the inner surface of each of the anterior portion and the posterior portion, and at least one unlined zone being unlined and unpadded on the inner surface of each of the anterior portion and the posterior position.
However, Mottram teaches the use of one or more pads (see [0018] and [0086]) to provide a means to adjust the shape and volume of the orthosis to optimize the effect thereof (see [0086]), and that multiple voids can be provided to allow desired growth (see [0005] in reference to regions (plural) where there is a void to allow desired growth (see [0005]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified each of the anterior portion and the posterior portion of the outer shell as disclosed by Mottram and to have included at least one lined zone having selectively positioned padding on the inner surface of each of the anterior portion and the posterior portion, and at least one unlined zone being unlined and unpadded on the inner surface of each of the anterior portion and the posterior position as taught and evidenced by the one or more pads utilized, and regions where there is a void of the disclosure of Mottram in order to have provided improved anterior and posterior portions of the outer shell that would add the benefit of provide a means to adjust the shape and volume of the orthosis to optimize the (head shaping) effect thereof (see [0086]) and to have provided multiple regions where there is a void to allow desired growth (see [0005]).
Furthermore, such a modification is held to be obvious since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)) (see MPEP 2144.04 VI B). In the instant case a duplication of lined zone with the selectively positioned padding, and the void which defines an unlined and unpadded zone to be positioned on each of the anterior and posterior portions of the outer shell provides the known and expected result of shaping the infant’s head into a desired shape.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mottram in view of Phillips et al. (WO-2018/145602 A1) (hereinafter Phillips).
In regards to claim 5, Mottram discloses the invention as discussed above.
Mottram further discloses wherein the plurality of ventilation holes (24) of the at least one unlined zone (portion of 110a and 110b with void between 20 and 30) are selectively arranged in a series of intersecting and/or spaced spiral curves or patterns terminating at a common inner circle (22 of 110; see figure 6a that 110a and 110b have a contoured upper edge, see figure 1a that 10a and 10b have a similar edge which forms 22; thus when 110a and 110b are connected they are considered to form 22; see annotated figure 6b below).
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Mottram does not disclose wherein a diameter of the ventilation holes varies from a largest diameter near or adjacent outer edges of the anterior portion and/or the posterior portion gradually to a smallest diameter closer to the common inner circle.
However, Phillips teaches an analogous device (10; see pg 5 ln 20-24]; see figures 2-7) for the analogous treatment of a head deformity of a patient (see [abstract]) the device (10) comprising analogous ventilation holes (28; pg 8 ln 29-34; see figure 2) and common inner circle (26; see pg 6 ln 1-6; see figure 6) wherein a diameter of the ventilation holes (28) varies from a largest diameter near or adjacent outer edges of the anterior portion and/or the posterior portion gradually to a smallest diameter closer to the common inner circle (26; see figure 2) for the purpose of providing optimized airflow and flexibility (see pg 8 ln 1-10).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ventilation holes as disclosed by Mottram and to have formed a diameter of the ventilation holes with a smaller diameter at the common inner circle and gradually increasing the diameters as the ventilation holes near outer edges of the anterior portion and/or the posterior portion as taught by Phillips in order to have provided improved ventilation holes that would add the benefit of providing optimized airflow and flexibility (see pg 8 ln 1-10).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mottram in view of Siddiqui et al. (US 20160302955 A1) (hereinafter Siddiqui).
In regards to claim 11, Mottram discloses the invention as discussed above.
Mottram further discloses a securing mechanism (50 of 110; see [0083]; see figures 1a and 6a) configured to move between a connected state when anterior and posterior portions are connected and a disconnected state when anterior and posterior portions are disconnected (see figures 2 and 6b), the securing mechanism comprising a latching mechanism (see [0083] in reference to 50 being any suitable latch mechanisms).
Mottram does not explicitly disclose the securing mechanism comprising a perimetral ridge protruding from an outer surface of the anterior and posterior portions and surrounding an interior portion, and a clasp configured to securely engage a latch of the interior portion in the connected state and pivot away from the latch in the disconnected state.
However, Siddiqui teaches an analogous securing mechanism (44; see [0044]; see figure 1) wherein the securing mechanism is a latch (see [0044]) comprising a perimetral ridge (outer ridge of 54; see [0045]; see figure 3) protruding from an outer surface of the anterior and posterior portions and surrounding an interior portion (60; see [0045]; see figure 3), and a clasp (48, 52, 62; see [0044] and [0048]; see figure 3) configured to securely engage a latch (58; see [0045]; see figure 3) of the interior portion in the connected state (see figure 8) and pivot away from the latch in the disconnected state (see figures 3-6) for the purpose of tightening and securing the device around the user’s anatomy and giving the user a mechanical advantage over just manually pulling the device tight (see [0012]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the latch securing mechanism as disclosed by Mottram and to have utilized the latch mechanism and associated structures as taught by Siddiqui in order to have secured the anterior and posterior portions of the cranial deformation orthosis device provided an improved securing mechanism that would add the benefit of tightening and securing the device around the user’s anatomy and giving the user a mechanical advantage over just manually pulling the device tight (see [0012]).
Conclusion
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/DANIEL A MILLER/Examiner, Art Unit 3786