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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/9/2026 has been entered.
Status of Claims
Claim(s) 1-4, 7-8, 10-15, 18-19, 21-31 is/are pending of which Claim(s) 1 and 15 is/are presented in independent form.
All references relied up on and not cited in the current Form 892 may be found in previous 892's or IDS'.
Claims 5-6, 9, 16-17, 20 cancelled.
Claims 1-4, 7-8, 10-15, 18-19, 21-22, 25-29 amended.
Previous 101 rejections withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 7-8, 10-15, 18-19, 21-31 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Rosicky is now the new primary reference relied upon.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: “[first/second] greatest radial distance” (claims 28-29) lacks antecedent basis in the specification.
Claim Objections
Claim 1, 7-8, 11, 24, 31 objected to because of the following informalities:
Claim 1 line 25 recites “a posterior extra growth area” should be -said posterior extra growth area-
Claim 7 line 3 recites “said anterior head growth” (as amended) should be -said anterior head growth area-
Claim 8 line 2 recites “said modified shape” should be -said modified head shape surface-
Claim 8 line 5 recites “said modified shape” should be -said modified head shape surface-
Claim 8 lines 3 and 6 recites “said one or more hold areas” should be -said one or more hold surface areas-
Claim 11 line 5 recites “said maximum second predetermined distance” should be -said second distance- (based on the other amendments)
Claim 25 line 2 recites “said anterior area” should be -said anterior second area-
Claim 25 line 5 recites “said posterior area” should be -said posterior second area-
Claim 24 line 2 recites “said second percentage” should be -said second predetermined percentage-
Claim 24 line 2 recites “said first percentage” should be -said first predetermined percentage-
Claim 31 line 2 recites “said second percentage” should be -said second predetermined percentage-
Claim 31 line 2 recites “said first percentage” should be -said first predetermined percentage-
Appropriate correction is required.
Examiner kindly asks for Applicant to review the readability and consistency of their claims with the terminology of their disclosure and to use more consistent terms.
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.
Claim 10-13, 18-19, 21-31 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 10 recites “said anterior growth area” in line 4 and wherein claim 1 recites both an “anterior head growth area” and an “anterior extra growth area” wherein it is unclear to which this term is supposed to be referring as written. For examining purposes, will be interpreted as “said anterior head growth area” (see previous related 112b).
Claim 10 recites “said posterior growth area” in line 7 wherein claim 1 recites both an “posterior head growth area” and an “posterior extra growth area” wherein it is unclear to which this term is supposed to be referring as written. For examining purposes, will be interpreted as “said posterior head growth area” (see previous related 112b).
Claims 11-13 rejected as being dependent on claim 10.
Claims 18-19, 21-24 as written are confusing and not clear and rejected under 112b for such issues. Claim 18 indicates the “second area” extends outward from the modified shape by a radial distance. Claim 19 indicates the radial distance is determined from a selected radial distance. Claim 21 says the radial distance comprises a maximum radial distance. Claim 22 then recites that the selected radial distance is a percentage of the maximum radial distance. However, this makes no sense as the selected radial distance is written as being/comprising the maximum radial distance, so they wouldn’t be some percentage of each other but exactly the same. Applicant’s disclosure and other claims appear to also indicate that the percentage here should be comparing the radial distance to the selected radial distance/maximum radial distance. As such, claim 22 in specific will be interpreted as “said [first/second] radial distance comprises a [first/second] predetermined percentage of said maximum [anterior/posterior] radial distance” wherein the selected radial distance and maximum radial distance appear to be the same distance.
Claims 25-31 are confusing for related reasons above indicated in claims 18-19, 21-24. Examiner kindly asks if the terminology of distances being claimed can have some level of consistency as the same distance for example of “first distance” in claim 1 is then called the “first radial distance” in claim 15, and then suddenly in claim 25 the “anterior area” which is presumed to mean the “anterior second area” is now having a distance being called “a maximum first radial distance” which appears as claimed to be the same distance as the “first radial distance” in the parent claim 15. This lack of consistency of claim terminology for the distances makes these claims as whole difficult to read and provides confusion on what distance is what. Applicant’s claims should be best matching their disclosure and the differing terminology just causes complete confusion. See interpretations below:
Claim 25-31 recites “a maximum [first/second] radial distance” which will be interpreted as “the [first/second] radial distance” from claim 15 as they appear to be meaning the same distance.
Claim 23 recites “said second predetermined percentage” and “”said first predetermined percentage”; however, claim 23 is written to depend from claim 21 which lacks antecedent basis for such terms. Will be interpreted as dependent on claim 22 instead.
Claim 24 recites “said second percentage” and “”said first percentage”; however, claim 24 is written to depend from claim 21 which lacks antecedent basis for such terms. Will be interpreted as dependent on claim 23 instead.
Claim 26 recites the limitation "said anterior portion" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites the limitation "said posterior portion" in line 5-6. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites the limitation "said anterior portion of said deformed shape" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 15 recites “an anterior portion of said cranial remodeling orthosis device”. Examiner will interpret this as referring to that “anterior portion”.
Claim 28 recites the limitation "said anterior portion" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "said posterior portion" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation “said uniform first radial distance” in line 2. There is insufficient antecedent basis for this limitation in the claim. Will be interpreted as “said first radial distance”
Claim 29 recites the limitation “said uniform second radial distance” in line 4. There is insufficient antecedent basis for this limitation in the claim. Will be interpreted as “said second radial distance”.
Examiner kindly asks for Applicant to review the present claims for how they are written and improve the clarity therein holistically.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 7-8, 10-11, 15, 18-19, 21-22, 25-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosicky (WO 2024153272 A1).
Regarding claim 1, Rosicky discloses a custom cranial remodeling orthosis device (Fig. 12-17) (see title) (Page 4) configured to reshape a deformed head shape (5) (Fig. 12-17) (Page 12-13, cranial orthosis is reshaping a deformed head shape 5 as shown in the figures) of a particular infant's head (Page 14, based on a specific infant’s model head) as said particular infant's head grows said cranial remodeling orthosis device being custom manufactured for said particular infant's head (Page 14, based on a specific infant’s model head as they grow, see Page 10 lines 7-16), comprising:
an asymmetric, monolithic interior surface (13) (lining 13, see Fig. 12-17, Page 25 line 2-30 and Page 6 line 1-5, there is provided in the cranial orthosis a monolithic lining 13, wherein the embodiments Fig. 11-16 provide the lining 13 as the most interior surface to make contact with the user as shown, wherein as shown in Fig. 12-17 the lining 13 is shown to be asymmetric), said interior surface (13) configured based upon a symmetric modified head shape surface (10) (Fig. 12-17, Pag 10 lines 1-10, inner wall 10 is a symmetric modified head shape surface corresponding to the final desired symmetric head shape of the infant) derived from a data file representing a deformed surface (5) representative of said deformed head shape (5) to be reshaped (Page 11-20-30 and Page 18 lines 1-26, shape of the invention is based on data representing a deformed surface representation of the infant’s head of the deformed head shape 5 shown in the figures to be reshaped) (See Annotated Fig. 13/16);
said modified head shape surface (10) and said deformed surface (5) defining one or more head hold areas where growth of said head is to be restrained (page 10 lines 8-16; page 13 lines 1-22, page 24; where the model of the infant’s head overlaps with that of the desired infant head the growth of the head will be limited being “hold areas”; where growth is to be supported an inner shell 4 will be placed to encourage growth therein) (See Annotated Fig. 13/16),
an anterior head growth area where growth of said head is to occur (Fig. 15-17 and Page 24 lines 17-22, the cranial orthosis may have an anterior head growth area defined by there being needed anterior head growth at the front) (See Annotated Fig. 16), and
a posterior head growth area where growth of said head is to occur (Fig. 12-14 and Page 24 lines 8-16, a posterior head growth area placed at the rear of the head wherein growth from a deformity is required) (See Annotated Fig. 13);
said asymmetric, monolithic interior surface (13) comprising one or more hold surface areas to restrain growth of said infant's head (page 10 lines 8-16; page 13 lines 1-22, page 24 and Fig. 12-17, wherein the interior surface 13 is without the shell 4 and adjacent to the wall 10 are hold areas where growth is not encouraged) (See Annotated Fig. 13/16),
said one or more hold surface areas determined from said modified head shape surface (10) and each disposed outside of and adjacent to a corresponding one of said head hold areas (page 10 lines 8-16; page 13 lines 1-22, page 24 and Fig. 13, shows the lining 13 have hold surface area being determined by the shape surface 10 and disposed outside of and adjacent those head hold areas where growth is limited) (See Annotated Fig. 13/16);
said asymmetric, monolithic interior surface (13) comprising an anterior extra growth area (13/4) providing an anterior extra growth room (4) for said infant's head contiguous to and extending outward from said anterior head growth area (Fig. 15-17, Page 24 lines 17-22; Page 22 lines 1-10, lining 13 has an anterior extra growth area defined by the area adjacent the anterior head growth room 4 defined by the inner shell 4 forming an inner cavity being a room where the head will grow into the room as defined by the shell 4) being contiguous and extending outwardly from such area) (See Annotated Fig. 16) and
a posterior extra growth area (13/4) providing a posterior extra growth room (4) for said infant's head contiguous to and extending outward from a said posterior head growth area (Fig. 12-14 and Page 24 lines 8-16 and Page 22 lines 1-10, lining 13 has a posterior extra growth area defined by the area adjacent the posterior head growth room 4 defined by the inner shell 4 forming an inner cavity being a room where the head will grow into the room as defined by the shell 4) (See Annotated Fig. 13);
said anterior extra growth area (13/4) extending outward from said corresponding anterior head growth area (10/4) by a first distance to provide said anterior extra growth room (4) (Fig. 15-17, the anterior extra growth room 4 defined by the placed inner shell 4 has a distance formed by its thickness between the lining 13 defining the anterior extra growth area and the head shape surface/inner wall 10 defining the anterior head growth area to the deformed head shape defining the anterior head growth area, the anterior side defining the first distance therein) (See Annotated Fig. 16 for indicated first distance);
a posterior extra growth area (13/4) extending outward from said corresponding posterior head growth area (10/4) by a second distance to provide said posterior extra growth room (4) (Fig. 12-14, the posterior extra growth room 4 defined by the placed inner shell 4 has a distance formed by its thickness between the lining 13 defining the posterior extra growth area and the head shape surface/inner wall 10 defining the posterior head growth area, the posterior side defining the second distance therein) (See Annotated Fig. 13 for shown second distance),
said second distance (Fig. 12-14) (4) being greater than said first distance (Fig. 15-17) (4) (See Fig. 12-17, wherein the distance/thickness of the inner shell 4 on the anterior side/first distance is smaller and less than that shown for the inner shell 4 on the posterior side/second distance) and said asymmetric, monolithic interior surface (13) being monolithic over the entirety of said one or more head hold areas, said anterior extra growth area and said posterior extra growth area (Fig. 12-17, the lining 13 is a single lining 13 thus being monolithic in entirety across all growth and hold areas it is placed on) (See Annotated Fig. 13/16).
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Regarding claim 2, Rosicky discloses the invention of claim 1 above.
Rosicky further discloses said anterior head growth area and said posterior head growth area each disposed at corresponding locations determined by the type of cranial deformity of said infant’s head (Page 1 lines 10-20; Page 13 lines 1-11; anterior and posterior head growth areas being where head growth is encouraged will be at locations determined by the type of deformity such as plagiocephaly; see Fig. 15-17 for anterior head growth and Fig. 12-14 for posterior head growth).
Regarding claim 3, Rosicky discloses the invention of claim 1 above.
Rosicky further discloses said first distance is a first radial distance from said anterior head growth area (10/4) (See Annotated Fig. 16, the first distance is an indicated radial distance from the inner surface 10 defining a head growth area to the inner surface of the shell 4 defining the cavity/growth room).
Regarding claim 4, Rosicky discloses the invention of claim 3 above.
Rosicky further discloses said second distance is a second radial distance from said posterior head growth area (10/4) (See Annotated Fig. 13, the second distance is an indicated radial distance from the inner surface 10 defining a head growth area to the inner surface of the shell 4 defining the cavity/growth room).
Regarding claim 7, Rosicky discloses the invention of claim 1 above.
Rosicky further discloses said anterior extra growth room (Annotated Fig. 16) extends uniformly outward over substantially its entirety from said anterior head growth area (Annotated Fig. 16, the anterior extra growth room as indicated is generally/substantially uniform in its extension from the indicated anterior head growth area);
said posterior extra growth room (Annotated Fig. 13) extends uniformly outward over substantially its entirety from said posterior head growth area (Annotated Fig. 13, the posterior extra growth room as indicated is generally/substantially uniform in its extension from the indicated posterior head growth area).
Regarding claim 8, Rosicky discloses the invention of claim 1 above.
Rosicky further discloses said anterior extra growth room (4) extends outward from said modified shape (10) by said first distance and tapers to adjacent said one or more hold areas (See Annotated Fig. 16, wherein the anterior extra growth room 4 and its indicated first distance tapers down to the adjacent hold area, and as shown extends outwardly from the modified shape surface 10);
and said posterior extra growth room (4) extends outward from said modified shape (10) by said second distance and tapers to adjacent said one or more hold areas (See Annotated Fig. 13, wherein the posterior extra growth room 4 and its indicated second distance tapers down to the adjacent hold area, and as shown extends outwardly from the modified shape surface 10).
Regarding claim 10, Rosicky discloses the invention of claim 8 above.
Rosicky further discloses said first distance is determined from a first selected radial distance between said deformed surface (5) and said modified head shape surface (10) in said anterior growth area (See Annotated Fig. 16, wherein the first distance as indicated is determined from the indicated first selected radial distance between the deformed surface 5 and the modified head shape surface 10);
said second distance is determined from a second selected radial distance between said deformed surface (5) and said modified head shape surface (10) in said posterior growth area (See Annotated Fig. 13, wherein the second distance as indicated is determined from the indicated second selected radial distance between the deformed surface 5 and the modified head shape surface 10).
Regarding claim 11, Rosicky discloses the invention of claim 8 above.
Rosicky further discloses said first distance comprises a first percentage of said first selected radial distance (See Annotated Fig. 16, wherein the first distance is implicitly a smaller percentage than the indicated first selected radial distance);
said second distance comprises a second percentage of said second selected radial distance (See Annotated Fig. 13, wherein the second distance is implicitly a smaller percentage than the indicated second selected radial distance).
Regarding claim 15, Rosicky discloses a cranial remodeling orthosis device (Fig. 12-17) (see title) (Page 4) configured to shape a particular infant’s head having a deformed head shape (5) (Fig. 12-17) (Page 12-13, cranial orthosis is reshaping a deformed head shape 5 as shown in the figures) (Page 14, based on a specific infant’s model head) as said particular infant's head grows, said cranial remodeling orthosis device custom manufactured for said particular infant's head (Page 14, based on a specific infant’s model head as they grow, see Page 10 lines 7-16), comprising:
an asymmetric, monolithic interior surface (13) (lining 13, see Fig. 12-17, Page 25 line 2-30 and Page 6 line 1-5, there is provided in the cranial orthosis a monolithic lining 13, wherein the embodiments Fig. 11-16 provide the lining 13 as the most interior surface to make contact with the user as shown, wherein as shown in Fig. 12-17 the lining 13 is shown to be asymmetric),
said interior surface (13) configured based upon a symmetric modified shape (10) (Fig. 12-17, Pag 10 lines 1-10, inner wall 10 is a symmetric modified head shape surface corresponding to the final desired symmetric head shape of the infant) derived from a data file representing a deformed shape (5) representative of said deformed head shape (5) to be reshaped (Page 11-20-30 and Page 18 lines 1-26, shape of the invention is based on data representing a deformed surface representation of the infant’s head of the deformed head shape 5 shown in the figures to be reshaped) (See Annotated Fig. 13/16);
said symmetric modified shape (10) with said deformed shape (5) defining hold areas configured to restrain head growth and growth areas configured to not restrain head growth (page 10 lines 8-16; page 13 lines 1-22, page 24; where the model of the infant’s head overlaps with that of the desired infant head the growth of the head will be limited being “hold areas”; where growth is to be supported an inner shell 4 will be placed to encourage growth therein) (See Annotated Fig. 13/16);
said asymmetric, monolithic interior surface (13) comprising first areas determined said hold areas (See Annotated Fig. 13, wherein there are “first areas” being at the indicated hold areas at the interior surface 13, these first areas being where the liner 13 is directly adjacent in the inner wall 10);
said asymmetric, monolithic interior surface (13) comprising second areas (See Annotated Fig. 13 and 16, second areas being the indicated “extra growth area”) determined from said growth areas (See Annotated Fig. 13 and 16, being areas of desired growth at the “Head Growth Areas” indicated),
said second areas contiguous with and extending outward from said growth areas to provide extra growth rooms (4) (See Annotated Fig. 13 and 16, and Page 24 lines 17-22; Page 22 lines 1-10, where shell 4 forms an inner cavity being a room where the head will grow into the room as defined by the shell 4 being contiguous and extending outwardly from such area indicated Head Growth Areas),
said extra growth rooms (4) provide growth space additional to that provided by said growth areas defined by said modified shape (Page 24 lines 17-22; Page 22 lines 1-10, the cavity/room defined by the shell 4 forms a growth space, being as shown additional to that as provided by the indicated Head Growth Areas in Annotated Fig. 13 and 16);
an anterior second area of said second areas disposed in an anterior portion of said cranial remodeling orthosis device Fig. 15-17 and Page 24 lines 17-22, the cranial orthosis may have an anterior head growth area defined by there being needed anterior head growth at the front) (See Annotated Fig. 16, the anterior second area being shown as indicated as the extra growth area) and extending radially outward by a first radial distance from a corresponding anterior one of said growth areas of said modified shape (10) (See Annotated Fig. 16, wherein there is a “first distance” radially extending outward from the modified shape 10 through the shell/room 4 to the inner surface of 13);
a posterior second area of said second areas disposed in a posterior portion of said cranial remodeling orthosis device ((Fig. 12-14 and Page 24 lines 8-16 and Page 22 lines 1-10, lining 13 has a posterior extra growth area defined by the area adjacent the posterior head growth room 4 defined by the inner shell 4 forming an inner cavity being a room where the head will grow into the room as defined by the shell 4) (See Annotated Fig. 13, the posterior second area being shown as indicated as the extra growth area) and extending radially outward by a second radial distance from a corresponding posterior one of said growth areas of said modified shape (10) (See Annotated Fig. 13, wherein there is a “second distance” radially extending outward from the modified shape 10 through the shell/room 4 to the inner surface of 13); and
said second radial distance (Annotated Fig. 13) (4) being greater than said first distance (Annotated Fig. 16) (4) (See Fig. 12-17, wherein the distance/thickness of the inner shell 4 on the anterior side/first distance is smaller and less than that shown for the inner shell 4 on the posterior side/second distance).
Regarding claim 18, Rosicky discloses the invention of claim 15 above.
Rosicky further discloses said anterior second area (Annotated Fig. 16, anterior extra growth room) extends substantially uniformly outward from said modified shape (10) by said first radial distance (Annotated Fig. 16, the anterior extra growth room/anterior second area as indicated is generally/substantially uniform in its extension from the modified shape 10, “first distance” indicated);
said posterior second area (Annotated Fig. 13, posterior extra growth room) extends substantially uniformly outward from said modified shape (10) by said second radial distance (Annotated Fig. 13, the posterior extra growth room/posterior second area as indicated is generally/substantially uniform in its extension from the modified shape 10, “second distance” indicated).
Regarding claim 19, Rosicky discloses the invention of claim 18 above.
Rosicky further discloses said first radial distance (first distance) is determined from a first selected radial distance between said deformed shape and said modified shape in said anterior portion (See Annotated Fig. 16, being the anterior portion, wherein the “first distance” is determined from the indicated distance extending between the deformed shape 5 and the modified shape 10);
and said second radial distance (second distance) is determined from a second selected radial distance between said deformed shape and said modified shape in said posterior portion (See Annotated Fig. 13, being the posterior portion, wherein the “second selected radial distance” is extending between the deformed shape 5 and the modified shape 10).
Regarding claim 21, Rosicky discloses the invention of claim 19 above.
Rosicky further discloses said first selected radial distance comprises a maximum anterior radial distance between said deformed shape (5) and said modified shape (10) in said anterior portion (See Annotated Fig. 16, wherein the first selected radial distance is a maximum); and
said second selected radial distance comprises a maximum posterior radial distance between said deformed head shape (5) and said modified shape (10) in said posterior portion (See Annotated Fig. 13, wherein the second selected radial distance is a maximum).
Regarding claim 22, Rosicky discloses the invention of claim 21 above (see 112b above).
Rosicky further discloses said first selected radial distance (interpreted as the first distance/first radial distance) comprises a first predetermined percentage of said first maximum anterior radial distance (See Annotated Fig. 16, wherein the first distance is an implicit percentage of the indicated selected radial distance being a maximum anterior radial distance); and
said second selected radial distance (interpreted as the second distance/second radial distance) comprises a second predetermined percentage of said maximum posterior radial distance (See Annotated Fig. 13, wherein the second distance is an implicit percentage of the indicated selected radial distance being a maximum posterior radial distance).
Regarding claim 25, Rosicky discloses the invention of claim 15 above.
Rosicky further discloses said anterior area extends radially outward from said modified shape (10) by a maximum first radial distance (“first distance”) and tapering to said first areas (See Annotated Fig. 16 being the anterior, wherein the anterior area extends radially outward from modified shape 10 by the first distance indicated being a maximum first radial distance, and then tapers to the first areas/hold areas therein); and
said posterior area extends radially outward from said modified shape (10) by a maximum second radial distance (“second distance”) and tapering to said first areas (See Annotated Fig. 16 being the posterior, wherein the posterior area extends radially outward from modified shape 10 by the second distance indicated being a maximum second radial distance, and then tapers to the first areas/hold areas therein).
Regarding claim 26, Rosicky discloses the invention of claim 25 above.
Rosicky further discloses said maximum first radial distance (‘first distance”) is determined from a first selected radial distance between said deformed head shape (5) and said modified shape (10) in said anterior portion (See Annotated Fig. 16, wherein the first distance is selected from the first selected radial distance); and
said maximum second radial distance (“second distance”) is determined from a second selected radial distance between said deformed head shape (5) and said modified shape (10) in said posterior portion (See Annotated Fig. 13, wherein the second distance is selected from the second selected radial distance).
Regarding claim 27, Rosicky discloses the invention of claim 26 above.
Rosicky further discloses said first selected radial distance is determined by utilizing radials extending outward from said anterior portion of said deformed shape to said modified shape (See Annotated Fig. 16, wherein the first selected radial distance is a radial from the anterior portion of the deformed shape 5 to modified shape 10); and
said second selected radial distance is determined by utilizing radials extending outward from said posterior portion to said modified shape (See Annotated Fig. 13, wherein the second selected radial distance is a radial from the posterior portion of the deformed shape 5 to modified shape 10).
Regarding claim 28, Rosicky discloses the invention of claim 27 above.
Rosicky further discloses said first selected radial distance comprises a first greatest radial distance between said deformed shape and said modified shape in said anterior portion (See Annotated Fig. 16, wherein the first selected radial distance is a greatest radial distance between deformed shape 5 and modified shape 10); and
said second selected radial distance comprises a second greatest radial distance between said deformed head shape and said modified shape in said posterior portion (See Annotated Fig. 13, wherein the second selected radial distance is a greatest radial distance between deformed shape 5 and modified shape 10).
Regarding claim 29, Rosicky discloses the invention of claim 28 above.
Rosicky further discloses said uniform first radial distance (first radial distance) comprises a first predetermined percentage of said first greatest radial distance (See Annotated Fig. 16, wherein the first radial distance is a percentage of the selected radial distance being the greatest radial distance); and
said uniform second radial distance (second radial distance) comprises a second predetermined percentage of said second greatest radial distance (See Annotated Fig. 13, wherein the second radial distance is a percentage of the selected radial distance being the greatest radial distance).
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) 12-14, 23-24, 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosicky (WO 2024153272 A1).
Regarding claim 12, Rosicky discloses the invention of claim 11 above.
Rosicky does not explicitly disclose said second percentage is selected to be greater than said first percentage.
However, Examiner notes that the Applicant’s specification lacks any criticality in the comparison of percentages outside of a mere happenstance of the deformed child head shape.
Furthermore, as can be seen in Annotated Fig. 13 and 16, the first percentage of the first distance to the first selected radial distance shown in Annotated Fig. 16 from the Figure may be inferred to be about 50% from the figure, and the second percentage of the first distance to the second selected radial distance as shown in Annotated Fig. 13 may be inferred to be about 60-70%, at least greater than the 50% of the first percentage.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have known that said second percentage is selected to be greater than said first percentage considering the provided Annotated Fig. 13 and 16 of Rosicky.
Furthermore, Rosicky discusses the size of the reduced inner cavity 12/shell 4 (being the first/second distance) being a percentage of the distance from the initial outer deformed head shape and the inner wall of the orthosis (being the desired modified head shape) (being the first/second selected radial distance, also called the target inner cavity), wherein this percentage may be 10-90% (Page 10 lines 0-8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the anterior and posterior areas with percentages between the 10-90% such that said second percentage is selected to be greater than said first percentage due to the anterior and posterior requiring different levels of encouraged growth dependent on the infant’s deformed head status (Rosicky Page 10 lines 0-10 and Page 13 line 0-11), furthermore this would have been obvious as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05. and “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984).
Regarding claim 13, Rosicky discloses the invention of claim 12 above.
Rosicky does not explicitly disclose said first percentage is selected to be 40%, and said second percentage is selected to be 70%.
However, Rosicky discloses the percentages as discussed may be chosen in a range of 10-90% (Page 10 line 0-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided said first percentage is selected to be 40%, and said second percentage is selected to be 70% since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. See MPEP § 2144.05.
Regarding claim 14, Rosicky discloses the invention of claim 12 above.
Rosicky does not explicitly disclose said second percentage is selected to be 70 percent.
However, Rosicky discloses the percentages as discussed may be chosen in a range of 10-90% (Page 10 line 0-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided said second percentage is selected to be 70 percent since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. See MPEP § 2144.05.
Regarding claim 23, Rosicky discloses the invention of claim 22 above (see 112b).
Rosicky does not explicitly disclose said second predetermined percentage is selected to be greater than said first predetermined percentage.
However, Examiner notes that the Applicant’s specification lacks any criticality in the comparison of percentages outside of a mere happenstance of the deformed child head shape.
Furthermore, as can be seen in Annotated Fig. 13 and 16, the first percentage of the first distance to the first selected radial distance shown in Annotated Fig. 16 from the Figure may be inferred to be about 50% from the figure, and the second percentage of the first distance to the second selected radial distance as shown in Annotated Fig. 13 may be inferred to be about 60-70%, at least greater than the 50% of the first percentage.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have known that said second percentage is selected to be greater than said first percentage considering the provided Annotated Fig. 13 and 16 of Rosicky.
Furthermore, Rosicky discusses the size of the reduced inner cavity 12/shell 4 (being the first/second distance) being a percentage of the distance from the initial outer deformed head shape and the inner wall of the orthosis (being the desired modified head shape) (being the first/second selected radial distance, also called the target inner cavity), wherein this percentage may be 10-90% (Page 10 lines 0-8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the anterior and posterior areas with percentages between the 10-90% such that said second percentage is selected to be greater than said first percentage due to the anterior and posterior requiring different levels of encouraged growth dependent on the infant’s deformed head status (Rosicky Page 10 lines 0-10 and Page 13 line 0-11), furthermore this would have been obvious as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05. and “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984).
Regarding claim 24, Rosicky discloses the invention of claim 23 above (see 112b).
Rosicky does not explicitly disclose said second percentage is 70 percent, and said first percentage is 40% percent.
However, Rosicky discloses the percentages as discussed may be chosen in a range of 10-90% (Page 10 line 0-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided said second percentage is 70 percent, and said first percentage is 40% percent since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. See MPEP § 2144.05.
Regarding claim 30, Rosicky discloses the invention of claim 29 above.
Rosicky does not explicitly disclose said second predetermined percentage is greater than said first predetermined percentage.
However, Examiner notes that the Applicant’s specification lacks any criticality in the comparison of percentages outside of a mere happenstance of the deformed child head shape.
Furthermore, as can be seen in Annotated Fig. 13 and 16, the first percentage of the first distance to the first selected radial distance shown in Annotated Fig. 16 from the Figure may be inferred to be about 50% from the figure, and the second percentage of the first distance to the second selected radial distance as shown in Annotated Fig. 13 may be inferred to be about 60-70%, at least greater than the 50% of the first percentage.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have known that said second percentage is selected to be greater than said first percentage considering the provided Annotated Fig. 13 and 16 of Rosicky.
Furthermore, Rosicky discusses the size of the reduced inner cavity 12/shell 4 (being the first/second distance) being a percentage of the distance from the initial outer deformed head shape and the inner wall of the orthosis (being the desired modified head shape) (being the first/second selected radial distance, also called the target inner cavity), wherein this percentage may be 10-90% (Page 10 lines 0-8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the anterior and posterior areas with percentages between the 10-90% such that said second percentage is selected to be greater than said first percentage due to the anterior and posterior requiring different levels of encouraged growth dependent on the infant’s deformed head status (Rosicky Page 10 lines 0-10 and Page 13 line 0-11), furthermore this would have been obvious as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05. and “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984).
Regarding claim 31, Rosicky discloses the invention of claim 30 above.
Rosicky does not explicitly disclose said second percentage is 70 percent and said first percentage is 40% percent.
However, Rosicky discloses the percentages as discussed may be chosen in a range of 10-90% (Page 10 line 0-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided said second percentage is 70 percent, and said first percentage is 40% percent since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. See MPEP § 2144.05.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Smith (US 20230149201 A1)
Mottram (US 20190015238 A1) (Fig. 4, extra growth room 35)
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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
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