DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 3/16/2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 337-362, drawn to a system of directional skin tightening.
Group II, claim(s) 363-367, drawn to a system of fractional coring.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of an excisor, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of US 2005/0283141 (Giovannoli). Giovannoli discloses the use of an excisor to excise skin using various different modalities (paragraphs 32-64). As noted in the paragraphs cited, an excisor is used in skin tightening procedures and thus is not a special technical feature.
During a telephone conversation with Kiri Lee Sharon on 7/7/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 337-362. Affirmation of this election must be made by applicant in replying to this Office action. Claims 363-367 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/15/2023, 9/13/2024, 1/23/2025, 11/21/2025, 3/11/2026, and 6/22/2026 are being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 340, 346, 348, 349 and 352 are objected to because of the following informalities:
In claim 340 lines 1-2, “consisting of mechanical means” should be --consisting of a mechanical means,--.
In claim 346, line 2, “a simultaneously or sequentially manner” should be --a simultaneous or sequential manner--.
In claim 348, line 2, “relatively” should be --relative--.
In claim 348, line 7, “said parameters are” should be --said at least one parameter is--.
In claim 348, line 8, “said controller” should be --said at least one controller--.
In claim 349, line 2, “RPM; said translation” should be --RPM; (b) said translation--.
In claim 349, line 3, “relatively to said skin” should be --relative to said skin--.
In claim 352, line 1, “comprising stopping mechanism” should be --comprising a stopping mechanism--.
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.
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: “stopping mechanism” in claim 352.
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.
Based on Applicant’ specification, “stopping mechanism” is a stopper (page 41).
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “mechanical means” in claims 340 and 341.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 338, 340, and 341 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Based on the wording of the claim 338, the tensioner appears to be a different component than the applicator. However, these do not appear to be different components based on the Applicant’s specification. The phrase “additionally comprising a tensioner” should read as --wherein said applicator comprises a tensioner…--.
For the purposes of compact prosecution, Examiner is interpreting the limitation as --wherein said applicator comprises a tensioner--.
Based on the wording of claims 340 and 341, the term “any other type of energy” in lines 3-4 could encompass several types of energy outside of the presented list, which could include solar, nuclear and chemical as well as other potential types not currently being considered. It is not clear how these energy types can be used in the process of excising tissue or providing contraction of expansion of the skin region.
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 337-362 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 337 recites the limitation “a region of skin tissue” in line 2. It is not clear if this is a new instance or refers to the “skin region” mentioned in line 1 of the claim.
Claims 338-362 inherit the deficiencies of claim 337 and are likewise rejected.
Claim 338 recites the limitation “before said step of producing a plurality of excised tissue portions” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 340 and 341 are unclear. It is not clear how the components are the excisor or applicator as these appear to be a mixture of structure (mechanical means) and process steps. Claim 340 should probably read as --…wherein the excisor is configured to produce the plurality of excised tissue portions is performed by selecting from a group consisting of…--. Claim 341 should probably read as --…wherein the applicator is configured to apply energy to the skin region by means selected from a group consisting of…--.
Claims 340 and 341 recite the limitation “any other type of energy” in lines 3-4. This limitation when combined with the other energy types for selection mentioned in the claim encompasses all types of energy, which renders the claim indefinite.
Claim 342 recites the limitation “each region of said skin tissue” in line 2. This is unclear as only one skin region is mentioned in claim 337.
Claim 344 recites the limitation "said at least one skin coring instrument" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 345 recites the limitation "said plurality of punches" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 346 recites the limitation "said plurality of punches" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 347 recites the limitation "said plurality of punches" in lines 1-2 and “said skin” in lines 5-6. There is insufficient antecedent basis for these limitations in the claim.
Claim 348 recites the limitation "the positioning", “said at least one robotic arm”, and “said skin area” in line 2; “the rotation” in line 4; and “said skin” in line 5. There is insufficient antecedent basis for these limitations in the claim.
Claims 352-354 inherit the deficiencies of claim 348 and are likewise rejected
Claim 349 recites the limitation "said rotation" in lines 1-2, “said translation” in line 2, “said at least one robotic arm”, and “said skin” in line 4. There is insufficient antecedent basis for these limitations in the claim.
Claim 350 recites the limitation "each punch" and “said plurality of punches” in line 1. There is insufficient antecedent basis for these limitations in the claim.
Claim 351 recites the limitation "each punch" and “said plurality of punches” in line 1. There is insufficient antecedent basis for these limitations in the claim.
Claim 352 recites the limitation "said plurality of punches" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 355 recites the limitation "the skin" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 356 recites the limitation "said at least one skin coring instrument" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 356, the phrase "such as" in line 4 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 357 recites the limitation “in communication with at least one of said excisor” in lines 3-4. This is unclear because there is not a plurality of excisors or any other element that might be an alternative element that would have been an alternative to the excisor claimed.
Claim 358 recites the limitation "said skin" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 358 recites the limitation “said skin could be” in line 1, which is unclear. The phrase “could be” makes it so that the skin is one, any, or maybe even none of the later elements recited thus making it unclear and indefinite.
Claim 360 recites the limitation "the preferred location" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 361 is unclear. The limitation appears to limit a method step but the claim is directed to a system. It is not clear how the step further limits the system.
Claim 362 recites the limitation “said skin coring instrument” and “said excised tissue” in line 2. There is insufficient antecedent basis for these limitations in the claim.
Due to the 112 issues of claim 344-351 and 356, for the purposes of compact prosecution, Examiner is interpreting claim dependencies as follows: Claims 344, 348, 349 and 356 are dependent on claim 343; and claims 345-347, 350 and 351 are dependent on claim 344.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 337 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,636,512. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of US 12,636,512 disclose a species that anticipates the current genus claim. The mapping is shown in the table below.
Present Application
US 12,636,512
337. A system of directional skin tightening of a skin region, comprising:
(i) an excisor configured to produce a plurality of excised tissue portions in a region of skin tissue; and
(ii) an applicator configured to apply at least one type of energy to said skin region in at least one predetermined direction to provide contraction or expansion of said skin region in a predetermined direction, so as to provide directional skin tightening in said skin tissue.
1. (Currently Amended) An apparatus of fractional coring for directional skin
tightening, comprising:
(i) an excisor configured to produce a plurality of excised tissue portions in a
region of skin tissue; and,
(ii) a securing fastener configured to secure, to the region of the skin tissue, a
tensioner having at least two portions, the tensioner adapted to provide contraction or expansion of said region in at least one predetermined direction; thereby promoting collagen growth and providing directional skin tightening in said skin tissue;
wherein said excisor is configured to be in communication with at least one RF
generator, adapted to provide RF energy, such that said excisor is adapted to provide RF energy to said region of skin tissue;
wherein said producing a plurality of excised tissue portions in a region of skin
tissue is performed by a system comprising at least one robotic arm, said at least one robotic arm comprising at least one skin coring instrument; and wherein said skin coring instrument comprises:
a micro-coring punch including a plurality of punches arranged in a predetermined pattern, the plurality of punches comprising at least six punches;
a motor configured to rotate each punches of the plurality of micro-coring punches around at least one axis of symmetry of each punch and wherein rotation of each punch
of the plurality of punches is synchronized with the rotation of a remainder of the plurality of punches;
a conveyor configured to advance the micro-coring punch towards skin and to position the micro-coring punch to penetrate the skin to a depth of at least two
millimeters; and
a stepper configured to step a micro-coring punch and locate the micro-coring punch such that at least one element selected from a group consisting of vertex, facet and
any combination thereof of a stepped micro-coring punch hexagon is overlapped with at least one element selected from a group consisting of vertex, facet and any combination thereof of a previous micro-coring punch hexagon.
For claim 337 and claim 1 of US 12,636,512, the underlined sections disclose the same excisor limitations. The italicized sections are the of the present claim and claim 1 of US 12,636,212 have an overlap in subject matter. Specifically, the italicized section of claim 1 of US 12,636,512 discloses a tensioner, which can be considered as a species of applicator that applies a type of energy (mechanical in this case) in a predetermined direction to the skin region, thus making the tensioner limitation of claim 1 of US 12,636,512 a species of the applicator. Claim 1 of US 12,636,212 further discloses the presence of additional components. Thus, the species claim of US 12,636,212 anticipates the current genus claim.
Claim Rejections - 35 USC § 102
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) 337-342 and 361-362 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by US 2016/0192961 (Ginggen et al., hereinafter Ginggen).
In regards to claim 337, Ginggen discloses methods and apparatuses for skin treatment (title and abstract; figures 1-17, 22, and 23; paragraphs [0005]-[0282]). Ginggen discloses a system (figure 22) with the following components:
(i) an excisor (micro-coring needle) configured to produce a plurality of excised tissue portions in a region of skin tissue (paragraphs [0081] and [0194]); and
(ii) an applicator (pinching rods) configured to apply at least one type of energy to said skin region in at least one predetermined direction to provide contraction or expansion of said skin region in a predetermined direction, so as to provide directional skin tightening in said skin tissue (paragraphs [0081], [0194], and [0265]; rods stretch and contract the skin region in a pre-determined direction to pinch skin).
In regards to claim 338, Ginggen discloses the limitations of claim 337. In addition, Ginggen states in paragraph [0081] that the stretch skin tissue before using the micro-coring needles.
In regards to claim 339, Ginggen discloses the limitations of claim 337. In addition, it can be seen in figure 22 that there is a direction of skin tightening. This direction can be considered as either an x or y direction depending on the point of reference.
In regards to claim 340, Ginggen discloses the limitations of claim 337. Ginggen further shows that the excisor can employ several different methods (paragraphs [0249]-[0264]) including mechanical means (drill – figures 1-2; wires or fiber on rotating component – figures 3A-B; blades-figure 4; paragraphs [0063] and [0254]), application of heat or laser energy (figure 12), any other type of energy (high pressure fluid – figures 5A-B; cold needles – figure 6A-B; chemical agents – figure 7; pulsed electrical fields -figure 8).
In regards to claim 341, Ginggen discloses the limitations of claim 337. In addition, Ginggen shows in figure 22 that the applicator is a set of pinching rods, which would be mechanical means.
In regards to claim 342, Ginggen discloses the limitations 337. Ginggen also discloses control of tensioning of the skin in paragraphs [0192]-[0198], which would require application of mechanical energy at powers or intensities to different regions of tissue (rods being pushed or rotated together or away from each other to create the tension).
In regards to claim 361, Ginggen discloses the limitations of claim 337. Due to the 112 issues of claim 361 and the additional limitation not further limiting the system, Ginggen meets the limitations of the claim.
In regards to claim 362 Ginggen discloses the limitations of claim 337. In addition, as noted on in paragraph [0123] the cutters are part of the coring instrument, and would thus be adapted to grind tissue.
Claim(s) 337-339, 355, 358, 359 and 361 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by US 2020/0188184 (Levinson et al., hereinafter Levinson).
In regards to claim 337-339, Levinson discloses methods and devices for skin tightening (title and abstract; figures 1-6; paragraphs [0006]-[0161]). Levinson discloses a device with the following:
(i) an excisor (coring needle, laser ablation, radiofrequency ablation or ultrasonic ablation, and blades) configured to produce a plurality of excised tissue portions in a region of skin tissue (paragraphs [0006], [0026], [0027], [0042], [0071], [0119], [0131],[0134], [0135], [0140], [0144], and [0159]); and
(ii) an applicator (dressing – functions as a tensioner that applies stretching tension, thus a mechanical means) configured to apply at least one type of energy to said skin region in at least one predetermined direction to provide contraction or expansion of said skin region in a predetermined direction, so as to provide directional skin tightening in said skin tissue (paragraphs [0006]-[0013],[0015]-[0019], [0024]-[0030], [0035]-[0066], [0068]-[0083], [0113], [0115]-[0119], [0144]-[0159]; dressing are used to tighten the skin where the dressings attach and can contract or expand the skin in a manner that is directional along both the x and y axis or directional along the x-axis).
In regards to claim 355, Levinson discloses the limitations of claim 337. Levinson further discloses wherein said system is configured to deliver additives to the skin (the method of the invention can include one or more useful therapeutic agents. Exemplary agents include one or more growth factors; paragraph [0113]), saline solution growth factors, platelet-derived growth factor "PDGF", transforming growth factor beta "TGF-J3", fibroblast growth factor "FGF", epidermal growth factor "EGF", and keratinocyte growth factor; one or more stem cells; steroids, agents which prevent post-inflammatory skin hyperpigmentation, hydroquinone, azelaic acid, kojic acid, mandelic acid, or niacinamide; one or more analgesics; one or more antifungals; one or more anti-inflammatory agents, or a mineralocorticoid agent, an immune selective anti-inflammatory derivative; one or more antimicrobials a foam; or a hydrogel, one or more antiseptics, one or more antiproliferative agents, one or more emollients; one or more hemostatic agents, a procoagulant, an anti-fibrinolytic agent, one or more procoagulative, one or more anticoagulative agents, one or more immune modulators, including corticosteroids and nonsteroidal immune modulators, one or more proteins; or one or more vitamins and any combination thereof.
In regards to claim 358, Levinson discloses the limitations of claim 337. Levinson further discloses wherein said skin is part of a treatment area selected from a group consisting of forehead, cheeks, jaw line, neck, thighs, upper arms, abdomen, face, eyelid, nose, forehead, chin, forehead, lips, nose, neck, chest, legs, back and any combination thereof (paragraph [0122]).
In regards to claim 359, Levinson discloses the limitations of claim 337. Levinson further discloses that the system is used for focal elimination of redundant dermal tissue for skin tightening, at least partially scar removal, skin rejuvenation (the devices, dressings, apparatuses, and methods are useful for treating one or more diseases, disorders, or conditions to improve skin appearance, to rejuvenate skin, and/or to tighten skin; paragraph [0024]), at least partially removal of pigment, at least partially tattoo removal, veins, acne, allodynia, blemishes, ectopic dermatitis, hyperpigmentation, hyperplasia, lentigo or keratosis, loss of translucency, loss of elasticity, melasma, photodamage, psoriasis, rhytides, wrinkles, sallow color, scar contracture, scarring, wrinkles, folds, acne scars, dyschromia, striae, surgical scars, cellulite, tattoos removal, cheek wrinkles, facial wrinkles, facial folds, skin aging, skin contraction, skin irritation/sensitivity, skin laxity, striae, vascular lesions, angioma, erythema, hemangioma, papule, port wine stain, rosacea, reticular vein, or telangiectasia, or any other unwanted skin irregularities and any combination thereof.
In regards to claim 361, Levinson discloses the limitations of claim 337. Due to the 112 issues of claim 361 and the additional limitation not further limiting the system, Levinson meets the limitations of the claim.
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.
Claim(s) 343-345, 347-354, 356, 357, and 360 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0188184 (Levinson et al., hereinafter Levinson) as applied to claim 337 above, and further in view of US 2011/0224693 (Bodduluri et al., hereinafter Bodduluri).
In regards to claim 343, Levinson discloses the limitations of claim 337. Levinson further discloses the use of at least one skin coring instrument (a plurality of excised tissue portions can be achieved by use of one or more hollow tubes or needles; paragraph [0131]). Levinson does not disclose the presence of at least one robotic arm. Bodduluri discloses the production of a plurality of excised tissue portions in a region of skin tissue is performed by a system comprising at least one robotic arm (a robotic system 25 comprising a robotic arm 27; the robotic system 25 for performing "punch-biopsy" type micro-tissue removals in a predetermined pattern across a patient's scalp using an appropriately sized coring needle; paragraphs [0046], [0082]), said at least one robotic arm comprising at least one skin coring instrument (a robotic system 25 comprising a robotic arm 27; the robotic system 25 for performing "punch-biopsy" type micro-tissue removals in a predetermined pattern across a patient's scalp using an appropriately sized coring needle; paragraphs [0046], [0082]). Bodduluri states that the robot control systems reduces the risks in the procedure associated with physician fatigue (paragraph [0082]). Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed, to have modified the method of Levinson, with the robotic system comprising a robotic arm of Boddoluri, for the advantage of performing a pattern removal of tissue using hundreds or even thousands of "punch-biopsy" type micro-tissue removals in a predetermined pattern across the patient's skin without the necessary complications and risks due to physician fatigue caused by repetitive manual tissue punches.
In regards to claim 344, the Levinson and Bodduluri discloses the method of claim 343. Levinson further shows that the at least one skin coring instrument comprises at least one selected from a group consisting of at least one needle, at least one punch and any combination thereof (a plurality of excised tissue portions can be achieved by use of one or more hollow tubes or needles; paragraph [0131]); said at least one skin coring instrument is configured to contact a surface of the skin to generate holes in the skin tissue by excising portions of the skin tissue (a plurality of excised tissue portions can be achieved by use of one or more hollow tubes or needles; paragraph [0131]).
In regards to claim 345, Levinson and Bodduluri disclose the limitations of claim 344. Levinson further discloses wherein at least a portion of said at least one skin coring instrument is disposable (the at least one needle will be disposable, as is well known in the medical field; paragraph [0131]).
In regards to claim 347, Levinson and Bodduluri disclose the limitations of claim 344. Levinson further discloses wherein said at least one skin coring instrument is adapted to penetrate said skin to a depth of 1 to 4 mm (excised tissue portions forms a hole in the skin region, where the depth of the hole is more than about 1.0 mm and results in a tissue portion having a length that is more than about 1.0 mm (e.g., about 1.0 mm, 1.5 mm, 2.0 mm. 2.5 mm, 3.0 mm, or 3.5 mm); paragraph [0129]) and wherein said at least one skin coring instrument is characterized by a radius of 0.15mm-2.0mm (exemplary components for performing excisions include a needle, such as a 16 gauge needle having an inner diameter of 1.194 mm; paragraph [0131]).
In regards to claim 348, Levinson in view of Bodduluri disclose the limitations of claim 343. Bodduluri further discloses wherein said system additionally comprising at least one controller adapted to control a positioning of said at least one robotic arm relatively to said skin area (a controller operatively associated with the processor and configured to position the moveable arm; paragraph [0010]). Bodduluri further discloses wherein said at least one controller comprising at least one engine adapted to control at least one parameter selected from a group consisting of a rotation, translation, angle of penetration of said at least one robotic arm relatively to said skin, depth of penetration (use of the robotically controlled system for needle location, alignment and depth control; paragraph [0082]), coverage rate, a diameter of at least one excised tissue multiplied by number of cores, different area of said skin to be treated and any combination thereof and wherein said at least one parameter is adjusted manually by the operator or automatically by said controller (receiving input via a user interface of at least one of a speed, an orientation, or a depth; see claim 22 of Bodduluri). Bodduluri states that the robot control systems reduce the risks in the procedure associated with physician fatigue (paragraph [0082]). It would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to have modified the system of Levinson, with the robotic system comprising a robotic arm and controller of Bodduluri, for the advantage of performing a pattern removal of tissue using hundreds or even thousands of "punch-biopsy" type micro-tissue removals in a predetermined pattern across the patient's skin without the necessary complications and risks due to physician fatigue caused by repetitive manual tissue punches.
In regards to claim 349, Levinson and Bodduluri disclose the limitations of claim 348. Levinson does not disclose wherein said rotation is at a speed in the range of 1000-7000 RPM. BODDULURI does not disclose wherein said rotation is at a speed in the range of 1000-7000 RPM, wherein said translation is at a speed in the range of 0-500mm/sec, wherein said translation of said at least one robotic arm relatively to said skin changes as said at least one robotic arm gets closer to said skin, wherein said rotation of said at least one robotic arm changes as said at least one robotic arm gets closer to said skin and penetrates said skin. However, Bodduluri discloses wherein the cannula is rotated in a drill-like motion (BODDULURI; paragraph [0060]), wherein the tissue can be excised using a quick reciprocating thrust along its longitudinal axis (BODDULURI; paragraph [0060]), wherein said translation of said at least one robotic arm relatively to said skin changes as said at least one robotic arm gets closer to said skin (the robotic arm 27 is moved by calculated positional and rotational offsets, and thus will inherently comprise wherein said translation of said at least one robotic arm relatively to said skin changes as said at least one robotic arm gets closer to said skin; paragraphs [0056], [0065]), and wherein said rotation of said at least one robotic arm changes as said at least one robotic arm gets closer to said skin and penetrates said skin (the robotic arm 27 is moved by calculated positional and rotational offsets, and thus will inherently comprise wherein said rotation of said at least one robotic arm relatively to said skin changes as said at least one robotic arm gets closer to said skin and penetrates said skin; paragraphs [0056], [0065]). Bodduluri states that the robot control systems reduce the risks in the procedure associated with physician fatigue (paragraph [0082]). It would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to have modified the system of Levinson, with the robotic system comprising a robotic arm and controller of Bodduluri, for the advantage of performing a pattern removal of tissue using hundreds or even thousands of "punch-biopsy" type micro-tissue removals in a predetermined pattern across the patient's skin without the necessary complications and risks due to physician fatigue caused by repetitive manual tissue punches.
In regards to claim 350, Levinson and Bodduluri disclose the limitations of claim 344. Bodduluri further discloses wherein each one skin coring instrument rotates individually in a predefined direction in a predetermined speed. Bodduluri discloses wherein each one skin coring instrument rotates individually in a predefined direction in a predetermined speed (the harvesting cannula cuts by rotation; wherein the controller controls the speed and direction; paragraphs [0077]; see claim 9 of Bodduluri). Bodduluri states that the robot control systems reduce the risks in the procedure associated with physician fatigue (paragraph [0082]). It would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to have modified the method of Levinson, with the robotic system of Bodduluri, for the advantage of performing a pattern removal of tissue using hundreds or even thousands of "punch-biopsy" type micro-tissue removals in a predetermined pattern across the patient's skin without the necessary complications and risks due to physician fatigue caused by repetitive manual tissue punches.
In regards to claim 351, Levinson and Bodduluri disclose the limitations of claim 344. Bodduluri further discloses wherein each one skin coring instrument translates individually (by rotating the cannula in a drill-like motion, or by a quick reciprocating thrust along its longitudinal axis; paragraph [0060]). Bodduluri states that the robot control systems reduce the risks in the procedure associated with physician fatigue (paragraph [0082]). It would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to have modified the method of Levinson, with the robotic system of Bodduluri, for the advantage of performing a pattern removal of tissue using hundreds or even thousands of "punch-biopsy" type micro-tissue removals in a predetermined pattern across the patient's skin without the necessary complications and risks due to physician fatigue caused by repetitive manual tissue punches).
In regards to claim 352, Levinson and Bodduluri disclose the limitations of claim 348. Bodduluri further discloses wherein said at least one controller comprises a stopper adapted to limit the depth to which at least a portion of said skin coring instrument penetrates said skin (the controller controls the depth of penetration, and thus will comprise a stopper adapted to limit the depth to which at least a portion of said skin coring instrument penetrates said skin; paragraphs [0008], [0082]). Bodduluri states that the robot control systems reduce the risks in the procedure associated with physician fatigue (paragraph [0082]). Note that Applicant’s specification gives physical or software examples of stopping so anything that stops the advancement of the skin coring instrument is a stopper. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to have modify the system of Levinson, with the robotic system comprising a robotic arm and controller of Bodduluri, for the advantage of performing a pattern removal of tissue using hundreds or even thousands of "punch-biopsy" type micro-tissue removals in a predetermined pattern across the patient's skin without the necessary complications and risks due to physician fatigue caused by repetitive manual tissue punches.
In regards to claim 353, Levinson and Bodduluri disclose the limitations of claim 348. In addition, Levinson discloses wherein an angle of penetration is substantially perpendicular to said skin (as shown; figure 1A).
In regards to claim 354, Levinson and Bodduluri disclose the limitations of claim 348. Bodduluri further discloses wherein said at least one controller is adapted to define at least one no-fly zone (the same image processing techniques described above can be used to avoid harm to existing hair follicles, while removing bits of tissue throughout a targeted region of the scalp; paragraph [0082]); said at least one no-fly zone being defined as an area to which said system provides no treatment (the same image processing techniques described above can be used to avoid harm to existing hair follicles, while removing bits of tissue throughout a targeted region of the scalp; paragraph [0082]). Bodduluri states that the robot control systems reduce the risks in the procedure associated with physician fatigue (paragraph [0082]). Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify Levinson to include the robot control system of Bodduluri , for the advantage of performing a pattern removal of tissue using hundreds or even thousands of "punch-biopsy" type micro-tissue removals in a predetermined pattern across the patient's skin without the necessary complications and risks due to physician fatigue caused by repetitive manual tissue punches.
In regards to claim 356, Levinson and Bodduluri disclose the limitations of claim 343. Bodduluri further discloses wherein said system additionally comprising at least one imaging subsystem adapted to guide said at least one skin coring instrument (movement of the robotic arm 27 is governed by a system controller in response to control signals derived from image data acquired by a pair of "stereo" cameras 28 attached to the distal end of the robotic arm; paragraph [0048]). Bodduluri states that the robot control systems reduce the risks in the procedure associated with physician fatigue (paragraph [0082]). Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to have modified the system of Levinson, with the robotic system comprising a robotic arm and camera of Bodduluri, for the advantage of performing a pattern removal of tissue using hundreds or even thousands of "punch-biopsy" type micro-tissue removals in a predetermined pattern across the patient's skin without the necessary complications and risks due to physician fatigue caused by repetitive manual tissue punches.
In regards to claim 357, Levinson discloses the limitations of claim 337. However, Levinson does not disclose the presence of additional at least one subsystem. Bodduluri discloses wherein said system additionally comprising at least one subsystem selected from a group consisting of a) vacuum subsystem adapted to apply suction to remove excising portions of said skin tissue (the cannula then extracts the graft using friction between the graft and the inside of the cannula or a combination of such friction and vacuum; paragraph [0076]); b) at least one retainer, in communication with at least one excisor configured to produce a plurality of excised tissue portions, adapted to contain said excised tissue, to avoid the use of vacuum; c) any combination thereof. Bodduluri states that the vaccuum is used to extract/remove tissue (paragraphs [0060], [0078],[0097]). Thus, it would have been obvious to one ordinary skill in the art, before the filing date of the claimed invention, to modify the system of Levinson to include a vacuum subsystem, as taught by Bodduluri in order to extract tissue.
In regards to claim 360, Levinson discloses the limitations of claim 337 but does not disclose wherein said system utilizes at least one selected from a group consisting of mechanical visualization, OCT, Ultrasound, machine learning algorithms, artificial intelligence, image processing and any combination thereof to efficiency select the preferred location of the tissue to be treated to enhance outcome of said treatment. In a related area, Bodduluri discloses a system that harvests tissue wherein said system utilizes at least one selected from a group consisting of mechanical visualization, OCT, Ultrasound, machine learning algorithms, artificial intelligence, image processing (image processing techniques described above can be used to avoid harm to existing hair follicles, while removing bits of tissue throughout a targeted region of the scalp; paragraph [0082]) and any combination thereof to efficiency select the preferred location of the tissue to be treated to enhance outcome of said treatment. Bodduluri states that the robot control systems reduce the risks in the procedure associated with physician fatigue (paragraph [0082]). Thus, it would have been obvious, to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the system of Levinson with the robotic system the robotic system and image processing of Bodduluri, for the advantage of performing a pattern removal of tissue using hundreds or even thousands of "punch-biopsy" type micro-tissue removals in a predetermined pattern across the patient's skin without the necessary complications and risks due to physician fatigue caused by repetitive manual tissue punches.
Claim(s) 346 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0188184 (Levinson et al., hereinafter Levinson) and US 2011/0224693 (Bodduluri et al., hereinafter Bodduluri) as applied to claim 344 above, and further in view of US 2020/0038051 (Austen).
In regards to claim 346, Levinson and Bodduluri disclose the limitations of claim 344 but do not show that the punches penetrate the skin in a sequential or simultaneous manner. Neither Levinson nor Bodduluri disclose wherein at least two skin coring instruments are adapted to penetrate said skin either in a simultaneously or sequentially manner. In a related area, Austen discloses a method and apparatus used for skin resurfacing. Austen discloses wherein at least two skin coring instruments are adapted to penetrate said skin either in a simultaneously or sequentially manner (at least two needles 120 (at least two skin coring instruments) are shown penetrating the skin simultaneously; figure 2A; paragraph [0044]). Austen states that this allows for generation of a plurality of damaged regions simultaneously to facilitate faster treatment of tissue by requiring fewer insertion/withdrawal cycles (paragraphs [0010] [0052]). Due to Levinson disclosing wherein the coring instrument can comprise one or more needles (Levinson; paragraph [0131]), it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to have modified the system of Levinson and Bodduluri, with the needles of Austen, for the advantage performing multiple tissue excisions more efficiently.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
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