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 treatment module comprising at least one coring element” in claim 1. The limitation describing the treatment module and the at least one coring element (“configured to remove a portion of skin tissue when the coring element is inserted into and withdrawn from the skin tissue”, functional language) fails to include sufficient structure to perform the recited function of "removing". The specification describes the treatment module and the at least one coring element as a needle hub comprising one or more hollow needles (para. 041, 127). Therefore, “a treatment module comprising at least one coring element” is interpreted as a needle hub comprising one or more hollow needles or any structural equivalent thereof that removes a portion of skin tissue when it is inserted into and withdrawn from the skin tissue.
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.
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 § 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 and 58-76 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.
Claim 1 recites the limitation "the coring element" in line 4. There is insufficient antecedent basis for this limitation in the claim. It is also unclear to the examiner if “the coring element” is meant to further define the at least one coring element. For examination purposes, “the coring element” is interpreted as “the at least one coring element”.
Claim 59 (line 1) and claim 60 (line 1) recites the limitation "the increase in collagen content ". There is insufficient antecedent basis for this limitation in the claim. For examination purposes, "the increase in collagen content” is interpreted as “the increase in collagen production".
Claim 60 recites the limitation "the performance " in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the performance” is interpreted as “a performance”.
Claim 63 recites the limitation "the area " in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the area” is interpreted as “an area”.
Claim 73 recites the limitation "one or more system parameters" in line 2. It is unclear to the examiner if “one or more system parameters” is meant to further define the one or more system parameters introduced in line 1 of claim 73 or new, additional, parameters. For examination purposes, “one or more system parameters” is interpreted as “the one or more system parameters”.
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.
Claim(s) 1 and 58-76 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levinson et al. (US 20190099199) [hereinafter Levinson].
Regarding claim 1, Levinson discloses a system 10, 151 for producing a cosmetic effect in skin tissue of a patient (Figs. 1A-F, 16G-N, para. 0006, 0134), the system comprising:
a treatment module 10 comprising at least one coring element 14 configured to remove a portion of skin tissue when the coring element 14 is inserted into and withdrawn from the skin tissue (Figs. 1A, 2, 9, para. 0110, 0127, 0134); and
an actuation assembly 151 operably attached to the treatment module 10 (Figs. 16G-N, para. 0134, and configured to translate and/or actuate the treatment module 10 in one or more directions relative to a surface of the skin tissue (para. 0143, 0163),
wherein the system 10, 151 is configured to perform a microcoring procedure that provides a therapeutic outcome and wherein the therapeutic outcome comprises an increase in collagen production (Figs. 1A-F, 9, para. 0106, 0142-0143, 0208; see note below).
Note: The limitation “wherein the system is configured to perform a microcoring procedure that provides a therapeutic outcome and wherein the therapeutic outcome comprises an increase in collagen production” is interpreted as functional language that describes the functionality and the intended use of the claimed invention. Therefore, “a microcoring procedure”, “a therapeutic outcome”, and “an increase in collage production” are not positively claimed and are interpreted as functional components that the system is capable of performing and providing. For example, “a therapeutic outcome” cannot be claimed as a structural component of the system, but is considered functional language that the system is capable of providing. The system of Levinson comprises all of the structure required for the functional language in the limitation (“a treatment module”, “at least one coring element”, and “an actuation assembly”) and is used for the same intended purpose of performing a microcoring procedure in the skin of a patient that provides a therapeutic outcome (see para. 0106, 0142-0143, 0208 of Levinson). Therefore, the system of Levinson is capable of performing a microcoring procedure that provides a therapeutic outcome and wherein the therapeutic outcome comprises an increase in collagen production A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114).
Regarding claim 58, Levinson discloses wherein the therapeutic outcome further comprises an increase in skin thickness (The examiner notes that “the therapeutic outcome” is not positively claimed, see note above for the rejection of claim 1. Since Levinson discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met).
Regarding claim 59, Levinson discloses wherein the increase in collagen content (interpreted as “the increase in collagen production”, see 112b rejection above) comprising an increase of at least 30%, at least 50%, and/or at least 70% (The examiner notes that “the increase in collagen content” is not positively claimed, see note above for the rejection of claim 1. Since Levinson discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met).
Regarding claim 60, Levinson discloses wherein the increase in collagen content (interpreted as “the increase in collagen production”, see 112b rejection above) is present three months after the performance of the microcoring procedure (The examiner notes that “the increase in collagen content” is not positively claimed, see note above for the rejection of claim 1. Since Levinson discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met).
Regarding claim 61, Levinson discloses wherein the system is configured to perform the microcoring procedure that provides the therapeutic outcome and achieves minimal or no scarring (The examiner notes that the limitation is functional, see note above for the rejection of claim 1 in regards to functional language. Since Levinson discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met).
Regarding claim 62, Levinson discloses wherein the minimal or no scarring comprises scarring with a Manchester Scar Scale value of less than 10 (The examiner notes that “the minimal or no scarring” is not positively claimed, see note above for the rejection of claims 1 and 61. Since Levinson discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met).
Regarding claim 63, Levinson discloses wherein the therapeutic outcome further comprises a skin surface area reduction of at least 3%, 5%, and/or 7% of the area treated (The examiner notes that “the therapeutic outcome” is not positively claimed, see note above for the rejection of claim 1. Since Levinson discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met).
Regarding claim 64, Levinson discloses wherein the system is configured to perform the microcoring procedure that provides the therapeutic outcome and achieves a GAIS score of at least 1 and/or 2 at 90 days after the performance of the microcoring procedure (The examiner notes that the limitation is functional, see note above for the rejection of claim 1 in regards to functional language. Since Levinson discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met).
Regarding claim 65, Levinson discloses wherein the therapeutic outcome further comprises replenishing essential nutrients of the skin and/or replenishing constituents of the skin (The examiner notes that “the therapeutic outcome” is not positively claimed, see note above for the rejection of claim 1. Since Levinson discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met).
Regarding claim 66, Levinson discloses wherein the therapeutic outcome further comprises at least a 50%, 75%, and/or 85% likelihood of achieving an LWSS improvement of at least 0.1, 0.2, 0.3, and/or 0.5 (The examiner notes that “the therapeutic outcome” is not positively claimed, see note above for the rejection of claim 1. Since Levinson discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met).
Regarding claim 67, Levinson discloses wherein the therapeutic outcome further comprises at least a 50%, 75%, and/or 85% likelihood of achieving a GAIS improvement of at least 1.0 (The examiner notes that “the therapeutic outcome” is not positively claimed, see note above for the rejection of claim 1. Since Levinson discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met).
Regarding claim 68, Levinson discloses wherein the therapeutic outcome further comprises at least a 50%, 75%, and/or 85% likelihood of achieving a significant level of patient satisfaction (The examiner notes that “the therapeutic outcome” is not positively claimed, see note above for the rejection of claim 1. Since Levinson discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met).
Regarding claim 69, Levinson discloses wherein the therapeutic outcome further comprises at least a 50%, 75%, and/or 85% likelihood of achieving no more than mild bleeding post-procedure (The examiner notes that “the therapeutic outcome” is not positively claimed, see note above for the rejection of claim 1. Since Levinson discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met).
Regarding claim 70, Levinson discloses wherein the therapeutic outcome further comprises at least a 50%, 75%, and/or 85% likelihood of avoiding a significant response related to ecchymosis, edema, erythema, hyperpigmentation, itching, pain and/or discomfort, redness, tenderness, and/or tightness (The examiner notes that “the therapeutic outcome” is not positively claimed, see note above for the rejection of claim 1. Since Levinson discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met).
Regarding claim 71, Levinson discloses wherein the therapeutic outcome further comprises a pain score of no more than 3.5 and/or no more than 3.0 (The examiner notes that “the therapeutic outcome” is not positively claimed, see note above for the rejection of claim 1. Since Levinson discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met).
Regarding claim 72, Levinson discloses wherein the therapeutic outcome further comprises removal of skin cores without formation of scars (The examiner notes that “the therapeutic outcome” is not positively claimed, see note above for the rejection of claim 1. Since Levinson discloses all of the structural components needed to necessitate the functional language of the claim, the claim is met).
Regarding claim 73, Levinson discloses further comprising an algorithm (interpreted as a computer component of a base unit of the system, para. 0134, 0164) and one or more system parameters (para. 0186-0187, 0189), wherein the algorithm is configured to adjust one or more system parameters in order to achieve the therapeutic outcome (para. 0164, 0185-0187, 0189).
Regarding claim 74, Levinson discloses wherein the algorithm is configured to automatically adjust the one or more system parameters (para. 0164, 0175, 0185-0187).
Regarding claim 75, Levinson discloses wherein the algorithm is configured to adjust the one or more system parameters based on one or more patient parameters (para. 0164, 0175, 0185-0187, 0214).
Regarding claim 76, Levinson discloses further comprising one, two, or more sensors (para. 0175, 0214), wherein the one or more patient parameters are recorded by the one, two, or more sensors (para. 0175, 0186, 0189, 0214).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771