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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A donning mechanism configured to accept insertion of a combination of the respirator mask body and respirator mask gasket and wrap around the user's head when the respirator mask is worn by the user as set forth in claim 5.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
As per paragraph [0060] of the specification, “a donning mechanism that has one or more straps that wrap around the user's head instead of over-ear straps is also within the scope of the invention”.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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.
Claim(s) 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Szasz et al. U.S. Publication No. (2019/0358473 A1) in view of Thornton U.S. Publication No. (2015/0045926 A1).
With respect to claim 1, Szasz et al. substantially discloses a respirator mask [0001] and (as shown in figs.1-11 comprising:
a respirator mask body (12, fig.4), the respirator mask body (12) including a plurality of openings (18) and [0051] for the exchange of gas and an air filtration media (14) configured to filter particles from air passing into and out of the respirator mask body [0051]; and
a respirator mask gasket (24) coupled to the respirator mask body (12), the respirator mask gasket (24) being sized and shaped responsively a portion of user's face including the user's nose and mouth [0055] and being configured to closely abut the user's face when worn [0055].
Szasz et al. substantially discloses the invention as claimed except the respirator mask gasket sized and shaped responsively to a three-dimensional scan of a portion of user's face including the user's nose and mouth.
Thornton however, teaches a medical mask formed for a particular user from a three-dimensional electronic model includes a body formed from a polymerized photopolymer material. An interior surface of the body is configured to seat on the particular user's face and comprises a physical embodiment of a three-dimensional electronic model corresponding to unique facial features of the particular user; a method of creating a three-dimensional electronic model for use in forming a custom medical mask for a particular user includes scanning a portion of the particular user's face using an electronic scanning device, generating a three-dimensional electronic model of the portion of the particular user's face based on the scanning, and transmitting the three-dimensional electronic model of the portion of the particular user's face for use in forming the custom medical mask for the particular user from a photopolymer using a stereolithography apparatus (abstract). The body may represent one or more pieces of thin material configured to cover the particular user's nose and/or mouth [0037].
In view of the teachings of Thornton, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the respirator mask gasket of Szasz et al. in like manner, such that the respirator mask is sized and shaped responsively to a three-dimensional scan of a portion of user's face including the user's nose and mouth such that it conforms substantially optimally to a user's unique facial features [0007] of Thornton.
With respect to claim 2, the combination of Szasz et al./Thornton substantially discloses the invention as claimed. As to the limitations, “wherein the respirator mask gasket is added to the respirator mask body via an injection molding process”, is drawn to an article of manufacture, and therefore the limitation is considered to be a product-by-process limitation that is given patentable weight only for the structural limitations imparted to the final product by the process. When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps (emphasis added). Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
With respect to claim 3, the combination of Szasz et al./Thornton substantially discloses the invention as claimed. Szasz et al. discloses the respirator mask body is not customized to the user's face [0056, in some cases, the face seal 24 is customized for a specific user, in other cases the face seal 24 can flexibly accommodate a variety of shapes and sizes of a user's face, which implies the respirator body is not customized].
With respect to claim 4, the combination of Szasz et al./Thornton substantially discloses the invention as claimed. Thornton further teaches at least one of the respirator mask gasket, the respirator mask, and the respirator mask body are manufactured via a three- dimensional printing process [0023, mask fabrication 16 may represent one or more well-known rapid-prototyping techniques such as, for example, three-dimensional printing (3DP), selective laser sintering (SLS), and/or STL].
With respect to claim 5, the combination of Szasz et al./Thornton substantially discloses the invention as claimed. Szasz et al. further discloses a donning mechanism or strap (28) configured to accept insertion of a combination of the respirator mask body and respirator mask gasket and wrap around the user's head when the respirator mask is worn by the user [0050].
With respect to claim 6, the combination of Szasz et al./Thornton substantially discloses the invention as claimed. Szasz et al. further discloses the donning mechanism or strap (28) includes an opening sized and positioned for removable insertion of the combination of the respirator mask body and respirator mask gasket (as shown in figs.4-5).
With respect to claim 7, the combination of Szasz et al./Thornton substantially discloses the invention as claimed. As to the limitations, “wherein the respirator mask gasket is designed using a model that overlays a respirator mask gasket blank onto the three-dimensional scan of the portion of user's face” is drawn to an article of manufacture, and therefore the limitation is considered to be a product-by-process limitation that is given patentable weight only for the structural limitations imparted to the final product by the process. When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps (emphasis added). Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
With respect to claim 8, the combination of Szasz et al./Thornton substantially discloses the invention as claimed. As to the limitations, “wherein the respirator mask gasket is designed using a model that overlays a respirator mask gasket blank onto the three-dimensional scan of the portion of user's face performs a Boolean subtraction on the respirator mask gasket blank to subtract portions of the respirator mask gasket blank responsively to the one or more features of the user's face so that the respirator mask gasket blank fits the portion of the user's face” is drawn to an article of manufacture, and therefore the limitation is considered to be a product-by-process limitation that is given patentable weight only for the structural limitations imparted to the final product by the process. When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps (emphasis added). Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
With respect to claim 9, the combination of Szasz et al./Thornton substantially discloses the invention as claimed. Szasz et al. further discloses the respirator mask gasket (24) is configured to have an air-tight seal with the user's face [0055, the face seal 24 is located behind the front shell 12 and contacts the users face to make an air tight seal against the skin. This forces all of the air intake through the front shell 12 and through the filter 14].
With respect to claim 10, the combination of Szasz et al./Thornton substantially discloses the invention as claimed. Szasz et al. further discloses the respirator mask gasket (24) is coupled to the respirator mask body (12) via at least one of a mechanical interlocking mechanism, as for example, clips or other mechanical devices (35, 30, fig.4) and [0057]-[0060].
With respect to claim 11, the combination of Szasz et al./Thornton substantially discloses the invention as claimed. Szasz et al. further discloses the respirator mask gasket (24) is made from a deformable material [0056, the face seal is made of silicone]. Note: Applicant specification discloses the same deformable material, in [0005], Applicant discloses the respirator mask gasket may be made from a deformable material such as silicon].
With respect to claim 12, the combination of Szasz et al./Thornton substantially discloses the invention as claimed, see rejection to claim 1 above. In [0011], Szasz et al. discloses the face seal may be overmolded to the support such that the face seal seals the perimeter of the filter between the support and the front shell], hence, the system for manufacturing the respirator mask includes an overmolding; where the claimed and prior art products are identical or substantially identical in structure, or are produced by identical or substantially identical processes, a prima facie case of obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775,227 USPQ 773 (Fed. Cir. 1985); as such, the combination of Szasz et al./Thornton substantially discloses a system for manufacturing a respirator mask comprising: a respirator mask body mold portion, the respirator mask body mold portion being configured to generate a respirator mask body that includes a plurality of openings for the exchange of gas and an opening for the insertion of a filtration media; and a respirator mask gasket mold portion, the respirator mask gasket mold portion being customized so that it is sized and shaped responsively to a three-dimensional scan of a portion of user's face including the user's nose and mouth, the respirator mask gasket mold portion being configured to couple to the respirator mask body mold portion, thereby forming a complete mold, so that a material may be injected into the complete mold.
With respect to claim 13, the combination of Szasz et al./Thornton substantially discloses the invention as claimed. Szasz et al. did not explicitly discloses the respirator mask gasket mold portion is specific to the user and the respirator mask body mold portion is not specific to the user, however, in [0056, Szasz et al. discloses the face seal 24 is customized for a specific user, in other cases the face seal 24 can flexibly accommodate a variety of shapes and sizes of a user's face], therefore, depending on the frequency of use of the respirator mask and depending on the specific user, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify respirator mask of Szasz et al./Thornton such that the respirator mask gasket mold portion is specific to the user and the respirator mask body mold portion is not specific to the user.
With respect to claim 14, the combination of Szasz et al./Thornton substantially discloses the invention as claimed. Thornton further teaches the respirator mask gasket mold portion is manufactured using a three-dimensional printing process [0023, mask fabrication 16 may represent one or more well-known rapid-prototyping techniques such as, for example, three-dimensional printing (3DP), selective laser sintering (SLS), and/or STL].
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 15-17 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-3 of prior U.S. Patent No. (12,201,859 B2). This is a statutory double patenting rejection.
Conclusion
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/OPHELIA A HAWTHORNE/ Primary Examiner, Art Unit 3786