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 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 2, 9, and 13 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.
The term “3DS” in claims 2, 9, and 13 is a relative term which render the claims indefinite. The term “3DS” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although, [0013] of the specification recites, “…physical or virtual (computer implemented) three-dimensional (a) training devices, tools, models, simulations and/or representations, and (b) demographically determined training devices, tools, models, simulations and/or representations, (collectively referred to herein as a “3DS” or “3-DS”)…”, it is unclear whether the Applicant is intending to encompass all of the listed alternatives within the claim or is intending to solely reference the portions of the 3DS definition appearing earlier in the claims.
For the purposes of examination, the Examiner assumes the Applicant is intending to solely reference the portions of the 3DS definition introduced prior to the corresponding recitation of “the 3DS”.
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.
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.
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.
Claims 1-13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rios [US20140120505A1].
Regarding claims 1-12, the claims share similar limitations to claims 13 and 15-20. For citations on rejection, see the rejection of claims 13 and 15-20 below.
Regarding claim 13, Rios discloses:
A method for providing training for at least one cosmetic treatment (Rios, Abstract, “Systems and methods are disclosed for an apparatus and method for practicing injection techniques through an injectable apparatus.”), the method comprising:
providing a plurality of demographically determined three-dimensional training devices, wherein each of the demographically three-dimensional training device includes
a structural framework corresponding to at least one human anatomical part (Rios, [0009], “The apparatus can simulate any human or animal part, such as, for example, the face, head, brain, neck, back, chest, spine, torso, arms, legs, hands, feet, mouth, or any other body part or portion of the body of interest.”),
at least one demographically determined simulated human tissue layer disposed on at least a portion of the structural framework and having at least one demographic bias indicator (Rios, [0009], “the anatomical model can include various injection conditions, such as, for example, layered skin, available in multiple tones and textures to mimic a diverse span of age, race, and skin texture.”), and
at least one defect disposed upon the simulated human tissue layer,
wherein the at least one defect is selected from the group consisting of a cyst, wound, lesion, scar, fat pad and lymphoma and combinations thereof (Rios, [0081], “the skin may have wrinkles, scars, hyper-pigmentation, lacerations, or other blemishes typically treated by injections.”); and
selecting at least one demographically determined three-dimensional training device from the plurality of demographically determined three-dimensional training devices based on at least one desired demographic bias indicator and at least one desired defect associated with the at least one cosmetic treatment (See note directly below.).
Although, Rios does not explicitly disclose the ability to select at least one training device from the plurality of training devices based on a desired defect to utilize with a specific cosmetic treatment, it would’ve been obvious before the effective filing date of the claimed invention to make such a selection as the concept of needing more than one model for various treatment options is merely separating the various capabilities of Rios and duplicating the same model for practicing said treatment options. As recited in MPEP2144.04 and provided below for ease of reference, when a prior art reads on a claim, wherein the only distinguishing factor resides in making a portion separable or duplicating parts, these distinguishing factors are insufficient to distinguish the claimed invention over the prior art; therefore, the claims of the instant application are rendered obvious over the prior art, Rios.
MPEP2144.04, Section V, C: “In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose.").”
MPEP2144.04, Section VI, B: “In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.).”
Regarding claim 15, Rios discloses:
The method of claim 13, wherein the simulated human tissue layer comprises at least one
epidermis-simulating layer which is the outermost layer of the 3DS (Rios, [0012], “the top layer of injectable skin consists of separate layers simulating mammalian skin: the epidermis...”),
a dermis-simulating layer adjacent to the epidermis-simulating layer comprising an upper dermis-simulating layer and a lower dermis-simulating layer (Rios, [0012], “the top layer of injectable skin consists of separate layers simulating mammalian skin: the epidermis, dermis, and hypodermis.”) and
a subcutaneoussimulating layer disposed inwardly from the dermis-simulating layer (Rios, [0013], “The injection apparatus can also simulate the back of the neck of an animal for subcutaneous injections.”).
Regarding claim 16, Rios discloses:
The method of claim 13, wherein each of the demographically three-dimensional training device comprises
at least one target site disposed upon the simulated human tissue layer (Rios, [0074], “the electromagnetic brake may be adjusted to simulate the resistance of skin, tissue, or muscle that the needle 212 would be penetrating.”).
Regarding claim 17, Rios discloses:
The method of claim 16, wherein the at least one target site comprises
the at least one defect disposed therein (Rios, [0081], “the skin may have wrinkles, scars, hyper-pigmentation, lacerations, or other blemishes typically treated by injections.”).
Regarding claim 18, Rios discloses:
The method of claim 13, wherein the at least one demographic bias indicator provides the training device with an aesthetic associated with at least one demographic factor selected from the group consisting of
age, gender, race, ethnicity, weight, height and skin tone (Rios, [0009], “the anatomical model can include various injection conditions, such as, for example, layered skin, available in multiple tones and textures to mimic a diverse span of age, race, and skin texture.”).
Regarding claim 19, Rios discloses:
The training device of claim 13, wherein the defect is a cutaneous defect-simulating structure (Rios, [0081], “the skin may have wrinkles, scars, hyper-pigmentation, lacerations, or other blemishes typically treated by injections.” Wrinkles, scars, hyper-pigmentation, and lacerations are forms of cutaneous defects.).
Regarding claim 20, Rios discloses:
The method of claim 13, wherein the defect protrudes above an outer-most surface of the skin-simulated layer (Rios, [0012], “the layers of skin may be thicker or thinner to simulate the skin of humans or animals with uneven skin layers or damaged skin. The separate layers of injectable skin may consist of elastomers simulating the look and feel of human or animal skin and muscle.”).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Rios as applied to claims 1-13 and 15-20 above, and further in view of Rreeves [US20100316728A1].
Regarding claim 14, Rios discloses delivering active ingredients to an anatomy model as cited above, but Rios does not disclose the use of intercellular, transcellular, or transappendageal delivery mechanisms.
Rreeves, however, discloses:
The active ingredient is delivered by mechanisms selected from at least one
intercellular, transcellular, or transappendageal (Rreeves, [0054]-[0059], The cited paragraphs discuss the application of various active ingredients to the skin and the impact of the ingredients on the intercellular matrix of the skin. The active ingredients discussed can be administered intercellularly, transcellularly, or transappendageally.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized topical ointments as in Rreeves, which can be administered intercellularly, transcellularly, or transappendegeally in the system executing the method of Rios with the motivation of training students in the administration of these ointments as taught by Rreeves over that of Rios.
Conclusion
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/Z.J.P./Examiner, Art Unit 3715
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715