DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election without traverse of groups I and II (claims 1-14 as per the applicant’s arguments) in the reply filed on 3/12/26 is acknowledged.
Claim Objections
Claim 5 is objected to because of the following informalities: line 1 should be amended to -the step of introducing the polymeric material into the mold cavity-. 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.
The following claim limitations
At least one cooling member (claim 11)
A first mechanism (claim 11)
A second mechanism (claim 11)
A third mechanism (claim 11)
has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder
Member (At least one cooling member - claim 11)
Mechanism (A first mechanism - claim 11)
Mechanism (A second mechanism - claim 11)
Mechanism (A third mechanism - claim 11)
coupled with functional language
for cooling the polyme1ic material within the mold cavity (At least one cooling member - claim 11)
for separating the sprue/vent plate from the main plate (A first mechanism - claim 11)
for separating the sprue/vent plate from the top plate (A second mechanism - claim 11)
for separating the bottom plate from the main plate (A third mechanism - claim 11)
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 11 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
series of tubes (¶0068) (At least one cooling member - claim 11)
spring mechanisms or core lifters (¶0070) (A first mechanism - claim 11)
spring mechanisms or core lifters (¶0070) (A second mechanism - claim 11)
spring mechanisms or core lifters (¶0070) (A third mechanism - claim 11)
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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 1-10 and 12 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.
Regarding claim 1:
The claim recites the limitation "the vents" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-10 are rejected due to their dependence on claim 1.
Regarding claim 6:
The claim recites the limitation "the main cavity" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 8:
The claim recites the limitation "the contoured surface" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
The claim recites the limitation "the distal end" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 12:
The claim recites the limitation "the opening" in line 6. There is insufficient antecedent basis for this limitation in the claim.
The limitation “the plates” in line 6 is unclear. The limitation is unclear since several “plates” have been established in claim 11 (on which this claim depends; see the sprue/vent plate, main plate, bottom plate and top plate) and its unclear as to which plate the limitation of claim 12 refers to. For the sake of examination, the office has assumed that this limitation refers to all of the plates.
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) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10058658 B1 to Voytilla in view of WO 0047390 A1 to Higgins et al. (Higgins).
Regarding claim 1:
Voytilla discloses:
A method of molding a device (10 with the mold assembly shown in figure 6a) comprising the steps of:
providing a mold assembly (400) having top plate (see the top plate A in figure 1 below), a sprue/vent plate (410) including a core portion (414), a main plate (420) including a recess (422) defining a mold cavity (402) having a contoured surface (see the contoured surface 424 as shown in figure 6C), and a bottom plate (430);
closing the mold assembly (400) such that the core portion (414) enters into the recess (422) in the main plate (420) to define a space corresponding to the shape (see the shape/device as shown in figure 2a) of the device (10 as shown in figure 6a);
introducing a polymeric material (see column 7, lines 40-65 in regards to introducing material into the mold and column 8, lines 1-23 for the polymer material) into said mold cavity (402) to fill said mold cavity (402) and said space to form said molded device (10) having a body (see body 12 as shown in figure 2a) and molded surface (see the molded surface 15 as shown in figure 2a) corresponding to said contoured surface (424).
Voytilla fails to disclose:
Separating the sprue/vent plate from the main plate to withdraw the core portion from within the molded device;
followed by separating the sprue/vent plate from the top plate;
followed by separating the bottom plate from the main plate; and
removing said molded device from the main plate.
Higgins teaches:
A mold (see figures 1-4) that includes a top plate (6), a sprue/vent plate (4), a main plate (7) and a bottom plate (3). The reference further teaches how the plates abut each other during the molding process (see figure 3) and are separated during the ejection of the of the molded part (as shown in figure 4 and mentioned on page 8, “Fig. 4 shows the tool in the open position with the synthetic cork in the cavity insert”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Voytilla to separate the sprue/vent plate, main plate, top plate and bottom plate from each other as taught by Higgins in order to remove the molded device from the mold (Higgins, page 8). While the Higgin reference does not mention the specific process or sequence as mentioned/required by the claim it would have been obvious to try based on the teaching of Higgins since there are only a finite number of way the mold assembly can be separated to remove the molded device from the mold and prepare for the next molding process. Further, the structure/arrangement of the mold assembly requires some of these steps in order to remove the molded device from the mold assembly. For example, the main plate and the sprue/vent plate would need to be separated from each other and further the main plate and the bottom plate would need to be separated from each other to remove the molded device from the mold assembly.
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Figure 1 - figure 6a of Voytilla, annotated by the examiner
Regarding claim 2:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Voytilla and Higgins:
The method of claim 1, wherein the step of separating the sprue/vent plate (410 of Voytilla) from the main plate (420 of Voytilla) causes the vents to break and the core portion (414 of Voytilla) to be withdrawn from within the molded device (as shown in figure 4 of Higgins the sprue/vent plate 4 is removed from the main plate 7 with the molded device 14 still in the main plate 7 and would be performed in Voytilla in the same manner) and the main plate (420).
Regarding claim 3:
Voytilla discloses:
The method of claim 1,wherein the step of removing the molded device (10) from the main plate (420) comprises removing the molded device (10, inherent since the molded device should be removed from the mold in order to use it).
Voytilla fails to disclose:
Removing the molded device through the bottom of the main plate.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Voytilla in this manner. As indicated above, the removal of the molded device from the bottom or top of the main plate would have been obvious to try since there are only two possible way to remove the molded device from the main plate (either the top of bottom).
Regarding claim 4:
Voytilla discloses:
The method of claim 1, wherein the step of introducing the polymeric material into the mold cavity (402) (see column 7, lines 40-65 in regards to introducing material into the mold and column 8, lines 1-23 for the polymer material) comprises injecting a polymeric material (column 8, lines 1-23 for the polymer material) into the mold cavity (402) through an injection nozzle and runner (see injection C in figure 1 above and runner as mentioned in column 7, lines 50-60 and column 8, lines 1-20) associated with (defined by the top plate and sprue/vent plate and as shown in figure 1 above element C) the top plate (A in figure 1 above).
Regarding claim 5:
Voytilla discloses:
The method of claim 1, wherein after the step of introducing polymeric material into the mold cavity (402), the mold assembly (400) is heated to cure the polymeric material or the mold assembly (400) is cooled (see cooling mentioned in column 8, lines 1-20) by supplying a cooling material (cooled by the material/mass of the main plate 420) to the main plate (420).
Regarding claim 6:
Voytilla discloses:
The method of claim 1, wherein the contoured surface (424) of the main cavity (402) is in the shape of a stopper (see the stopper 10 as shown in figure 2a) having a main body (12) defining an open rearward end (14), a closed front end (20), and a cylindrical sidewall (15) extending between (as shown in figure 2a) the open rearward (14) and the closed front end (20).
Regarding claim 7:
Voytilla discloses:
The method of claim 6, wherein the shape of the contoured surface (424) is configured to create a plurality of ribs (see ribs 17-19 as shown in figure 2a) extending radially outward around a perimeter of the main body (12) and axially spaced apart (as shown in figure 2a) along this main body (12).
Regarding claim 8:
Voytilla discloses:
The method of claim 6, wherein the bottom plate (430) has a flat face configured to create a stopper having a flat face (see flat face 432 as shown in figure 6a) or the bottom plate (430) includes a contoured surface (424) configured to create a stopper having a flat portion (see flat portion 20 as shown in figure 2b) on an outer edge of a closed front end of the stopper (10)(as shown in figure 2B) and extending inward from the outer edge of the stopper (flat face 20 extends inward as part of body 12 as shown in figure 2b) and wherein the contoured surface (424) is shaped to create a projection (21 or 19 as shown in figure 2b) extending from the closed front end (20), wherein the projection (21) defines a base as it intersects with the distal end of the stopper (see how 21 projects from 20 radially outward) and extends from the flat portion of the top of the closed front end (as shown in figure 2B), said projection being configured to cooperate within a syringe barrel to reduce dead space during injection (as shown in figures 5a and 5b where the projection wraps around the distal end of the stopper to form a seal).
Regarding claim 9:
Voytilla discloses:
The method of claim 1. including the step of providing a film (20/21) between the bottom plate (430) and the main plate (420) and wherein upon closing of the mold assembly (“barrier material” column 8, lines 1-10), the film (20/21) is sandwiched between the bottom plate (430) and the main plate (420) and upon removal of the device from the mold assembly, the film (20/21) is secured to the molded device (10)(as shown in figure 2a).
Regarding claim 10:
Voytilla discloses:
The method of claim 9, including the step of trimming excess film from the molded device (column 8, lines 20-23).
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10058658 B1 to Voytilla in view of US 4620958 A to Wiechard and US 2987772 A to Beatty.
Regarding claim 11:
Voytilla discloses:
A system for molding a device (10 with the mold assembly shown in figure 6a) comprising:
a mold assembly (400) having top plate (see the top plate A in figure 1 above), a sprue/vent plate (410), a main plate (420), and a bottom plate (430), the sprue/vent plate (410) including a core portion (414) extending from a surface (as shown in figure 6a) thereof, the main plate (420) including a recess (422) defining a mold cavity (402) having a contoured surface (see the contoured surface 424 as shown in figure 6C), said mold cavity (402) configured for receiving the core portion (414) from the sprue/vent plate (410) to define a space (as shown in figure 6C) corresponding to the shape (see the shape/device as shown in figure 2a) of the device (10 as shown in figure 6a) to be molded;
an injection nozzle (see the injection nozzle C in figure 1 above) and runner (runner as mentioned in column 7, lines 50-60 and column 8, lines 1-20) mated to the top plate (A in figure 1 above), said injection nozzle (C in figure 1 above) and runner (as mentioned in column 7, lines 50-60 and column 8, lines 1-20) configured for supplying a polymeric material (column 8, lines 1-23 for the polymer material) into the mold cavity (402) to fill said space to form said molded device having a body (see body 12 as shown in figure 2a) and molded surface (see the molded surface 15 as shown in figure 2a) corresponding to said contoured surface (see the contoured surface 424 as shown in figure 6C).
Voytilla fails to disclose:
At least one cooling member for cooling the polymeric material within the mold cavity;
a first mechanism for separating the sprue/vent plate from the main plate to withdraw the core portion from within the molded device;
a second mechanism for separating the sprue/vent plate from the top plate; and
a third mechanism for separating the bottom plate from the main plate to enable removal of the molded device from the main plate.
Beatty teaches:
A system (figure 1) for molding a device (50). The system includes a main plate (22) and a sprue/vent plate (21). Further, the system includes a cooling member/tubes (61/62) for cooling the main plate and allowing the molded material to cure (column 2, lines 50-55).
Wiechard teaches:
A system (figure 2) for molding a device (20). The system includes a main plate (33) and a sprue/vent plate (32). The system also includes mechanisms (spring and pins 34 and 37) for allowing the plates to separate from each other (column 4, lines 30-50).
Regarding the limitation “At least one cooling member for cooling the polymeric material within the mold cavity”:
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Voytilla to further include cooling members/tubes (consistent with the 35 USC 112(f) interpretation above) to supply coolant to the main plate as taught by Beatty to cool the main plate and cure the molded device. The Voytilla reference indicates the mold is cold (column 8, lines 5-15) but fails to establish how it is done and the cooling members/tubes of Beatty would provide this function.
Regarding the limitation “a first mechanism for separating the sprue/vent plate from the main plate to withdraw the core portion from within the molded device; a second mechanism for separating the sprue/vent plate from the top plate; and a third mechanism for separating the bottom plate from the main plate to enable removal of the molded device from the main plate”:
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Voytilla to further include first, second and third mechanisms between the sprue/vent plate, main plate, top plate and bottom plate as taught by Wiechard to allow for the removal of the molded device and preparation for the molding of the next device (Wiechard, column 4, lines 30-50).
Regarding claim 12:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Voytilla, Beatty and Wiechard:
The system of claim 11, wherein the first, second. and third mechanisms (incorporated from Wiechard into Voytilla) for separating the top plate (A in figure 1 above of Voytilla), sprue/vent plate (410 of Voytilla), main plate (420 of Voytilla), and bottom plate (430 of Voytilla) of the mold assembly (400 of Voytilla) comprises a series of spring mechanisms of varying force (see the spring mechanisms 34 of Wiechard incorporated into Voytilla) or a series of core lifters (not shown) to sequentially separate the sprue/vent plate from the main plate: the sprue/vent plate from the top plate; and the bottom plate from the main plate and wherein the spring mechanisms include leader pins (see the pins 37 of Wiechard incorporated into Voytilla) to limit the opening of each of the plates.
Regarding claim 13:
Voytilla discloses:
The system of claim 11, wherein a film (20/21) can be inserted between the bottom plate (430) and the main plate (420) and wherein closing of the mold assembly (400) causes the film to be sandwiched (“barrier material” column 8, lines 1-10)between the bottom plate (430) and the main plate (420) such that the film is secured to the molded device (as shown in figure 2a).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10058658 B1 to Voytilla, US 4620958 A to Wiechard and US 2987772 A to Beatty as applied to claim 13 above, and further in view of US 20170368264 A1 to Fournier et al. (Fournier).
Regarding claim 14:
Voytilla, Wiechard and Beatty fail to disclose:
The system of claim 13,including a trim die with a flat faced punch for removing excess film from the molded device.
Fournier teaches:
A system (figure 6) that includes a mold (301/302) for molding a device (513). Further, the system includes a die (350) for removing the excess material (¶0064).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Voytilla to further include a die as taught by Fournier for removing excess material from the device (¶0064).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is prior art:
US-20040099994-A1
Brinkhues
See the sprue/vent plate 14 and main plate 15
US-20060089602-A1
Boucherie
See the sprue/vent plate 12 and the main plate 13
JP-2009061343-A
KOBAYASHI
See the device 87
JP-2005013315-A
KOBAYASHI
See the mold 83
JP-2012147859-A
MAEDA
See the device 1/21/11/31
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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