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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02 March 2026 has been entered.
Response to Arguments
Applicant's arguments filed 02 March 2026 have been fully considered but they are not persuasive.
Applicant argues that Chomas is directed to minimally invasively cutting fibrous septae to release and loosen the dermis from the underlying connective tissue and does not teach insertion location is in a crease or fold and advancing the instrument to first and second treatment site at the buttocks and the thigh (page 6). In addition, applicant argues that Knowlton teaches fractional resection of external punching to resect skin and fat, thus, one of ordinary skill in the art would not modify Chomas based on treatment of cobblestone surface morphology of Knowlton (page 7). Applicant further argues that Knowlton 251 uses inserting instrument for injection of a cooling fluid to contract collagen , which is completely divergent from Chomas’ cutting septae to release and loosen the dermis (pages 7-8). Finally, applicant argues that Chomas, Knowlton and Knowlton 251 do not disclose the advancement and treatment at two treatment sites by inserting through one opening (page 8).
However, the examiner respectfully disagrees.
Chomas is directed to cellulite treatment device and cellulites appears in hips, buttocks, and legs ([0003]). The examiner has cited Chomas for an instrument insertion location for treating cellulite, but has not referenced to Chomas for “a crease or fold in skin where the buttocks meets the thigh.” Thus, the examiner has incorporated “Knowlton 251” which visually showed the treatment areas to be buttocks and thighs including a crease/fold where the buttocks meets thigh, Figures 54A and 54B clearly shows inserting the instrument (labelled as 10 in Figure 54B) into the crease between thigh and buttocks as claimed. Moreover, the examiner notes that paragraph [0297] explicitly discloses “infragluteal fold” which is a medical term for crease or fold where buttocks meets thigh as claimed.
In response to applicant's argument that combination of Chomas in view of Knowlton, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Specifically, Knowlton was cited for inserting location of the tool, not for combining Chomas with external treatment of Knowlton.
Moreover, the examiner further cited Knowlton 521 which explicitly disclose advancing within the patient’s body for multiple target sites and treatment at the sites as follows:
Knowlton 251 teaches treating cellulite (apparatus used to correct buttock ptosis and diminishment of cellulite [0258]), in infragluteal folds, uniform flap is raised with closed dissection over the buttocks and the superior aspect of the posterior lateral thigh ([0297]; which reads on the limitation of “a crease or fold in the skin where the buttocks meets the thigh”) and a dissecting tissue in a substantially uniform plane of dissection includes a housing configured to be advanced under a tissue layer (abstract) and advancing the instrument to target region ([0155] and [0249]), and figures 54A and 54B show inserted instrument at the transition of buttocks and thigh, advanced toward buttocks regions and transecting the septae to correct cellulite ([0249]), thus, reads on claimed advancing the instrument from first to second treatment site with the instrument inserted through the opening. Knowlton 251 further teaches closed advancement using a closed flap dissection with a uniform flap ([0083] Figures 68-71) and surgeon can advance the instrument to stop at a selected end point within tissue site and withdraw back to the incision site or some selected point in between ([0288]).
The examiner further submits that Knowlton 251 is directed to treating cellulite by transecting the septae ([0249]), which is analogous to Chomas’ cutting tool for creating a plane of dissection which cuts or resects the fibrous septae responsible for creating the chambers of fat cells, treatment ([0165]). Thus, Knowlton 521 is not different from Chomas, rather they are concerned with treating cellulite by disrupting septum.
Therefore, rejection is proper and maintained, and the examiner notes that the rejection has been modified in view of amendment.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 17 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a method of treating, with an instrument, cellulite on a thigh and a buttock of a patient, and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “determining an instrument insertion location based on a first location of a first treatment site at the buttock, a second location of a second treatment site at the thigh, and a length of the instrument, wherein the instrument insertion location is in a crease or fold in skin where the buttock meets the thigh.”
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to determining a location in a crease or fold in skin where the buttock meets the thigh, based on target treatment locations and length of the instrument to be inserted. The determination of the location can be performed by observing the crease or fold of buttock and the thigh, and surgeon can find a best location of insertion, by judging based on shortest travel of the instrument to first and second target sites and length of the instrument that can reach the target site from the insertion point. These determination can be conducted by mental framework of observation, judgement and opinion. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “creating an opening through the skin at the instrument insertion location inserting the instrument through the opening; advancing the instrument to first and second treatment sites.” Creating an opening and inserting instrument and advancing the instrument to target location merely amounts to a post-solution insignificant activity. There is no recitation of positively performing treatment by the instrument, but the claim limitation merely recites inserting the instrument to the determined location by mental framework, and advancing the instrument to target locations.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 17 is ineligible.
Claim 21 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 17 rejection.
Claim 2 recites the following elements: “determining the instrument insertion location when the patient is standing.” This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 21 is ineligible.
Allowable Subject Matter
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 17 is allowable if amended to overcome 101 rejection, and subsequently dependent claims 18-21 are objected to as being dependent upon a rejected base claim, but would be allowable if independent claim 17 is amended to overcome 101 rejection set forth above.
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 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.
The following rejection has been modified in view of applicant's arguments and/or amendments.
Claims 1, 4, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over “Chomas et al.,” US 2012/0165725 (hereinafter Chomas), “Knowlton,” US 2018/0000504 (hereinafter Knowlton), and “Knowlton et al.,” US 2004/0049251 (hereinafter Knowlton 251).
Regarding to claim 1, Chomas teaches a cellulite treatment method comprising:
creating an instrument insertion location (a cutting tool is inserted through a conduit through entry hole through the skin [0084], a cutting tool penetrate the skin or be placed through a hole in the skin [0140]; applicator inserted through the skin using a subdermal catheter through a hole in the skin [0179]; incision or other hole in the skin created by various dissection devices [0185]);
inserting an instrument through the insertion site opening through the skin ([0084], inserting cutting blade percutaneously [0194]);
advancing the instrument, to treatment site to disrupt a septum at the treatment site (cutting tool for creating a plane of dissection which cuts or resects the fibrous septae responsible for creating the chambers of fat cells, treatment [0165]).
Chomas discloses treating a cellulite wherein the patient has a thigh and a buttocks ([0016]), but does not teach the instrument insertion location is in a crease or fold in the skin where the buttocks meets the thigh, and advancing the instrument to first and second treatment site at the buttocks and the thigh.
However, in the analogous field of endeavor in cellulite treatment method, Knowlton teaches treating cellulite ([0434]), in infragluteal folds ([0477]; which reads on the limitation of “a crease or fold in the skin where the buttocks meets the thigh”) and advancing instrument in treating cellulite in areas of buttocks and thighs ([0362] discloses cellulite treatment is applied for areas of the skin with cobblestone appearances in the buttocks and lateral thighs, thus instrument is advanced to the treatment sites of thigh and buttocks).
Knowlton does not further teach advancing instrument to first and second site with the instrument inserted through the opening as amended.
However, the examiner submits Knowlton 251 teaches treating cellulite (apparatus used to correct buttock ptosis and diminishment of cellulite [0258]), in infragluteal folds, uniform flap is raised with closed dissection over the buttocks and the superior aspect of the posterior lateral thigh ([0297]; which reads on the limitation of “a crease or fold in the skin where the buttocks meets the thigh”) and a dissecting tissue in a substantially uniform plane of dissection includes a housing configured to be advanced under a tissue layer (abstract) and advancing the instrument to target region ([0155] and [0249]), and figures 54A and 54B show inserted instrument at the transition of buttocks and thigh, advanced toward buttocks regions and transecting the septae to correct cellulite ([0249]), thus, reads on claimed advancing the instrument from first to second treatment site with the instrument inserted through the opening. Knowlton 251 further teaches closed advancement using a closed flap dissection with a uniform flap ([0083] Figures 68-71) and surgeon can advance the instrument to stop at a selected end point within tissue site and withdraw back to the incision site or some selected point in between ([0288]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify insertion site as taught by Chomas to incorporate teaching of Knowlton and Knowlton 251, since device entering the gluteal fold was well known in the art as taught by Knowlton and advancing to target region was well known in the art as disclosed by Knowlton 251. One of ordinary skill in the art could have combined the elements as claimed by Chomas with no change in their respective functions, inserting the cutter into the skin in a crease or fold where buttocks meet thigh, advancing the instrument to target regions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide cellulite correction in the buttocks and thighs ([0362] Knowlton), and there was reasonable expectation of success.
Regarding to claim 4, Chomas, Knowlton, and Knowlton 251 together teach all limitations of claim 1 as discussed above.
Knowlton further teaches the patient is in a standing in figures 54A-B which shows determining location is in the cease where the buttock meets the thigh.
Regarding to claims 11-12, Chomas, Knowlton, and Knowlton 251 together teach all limitations of claim 1 as discussed above.
Knowlton discloses Langer’s lines are used for directional guidance of the instrument ([0506]) wherein resection field is achieved by following Langer’s lines ([0392]) and also at right angles to Langer’s line ([0392] and [0398]).
Claims 2-3, 5-6, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Chomas and Knowlton, and Knowlton 251 as applied to claim 1 (and claim 2 for claims 3 and 5-6, and 14-15) above, and further in view of “Hart,” US 2014/0335072 (hereinafter Hart).
Regarding to claim 2, Chomas and Knowlton, and Knowlton 251 together teach all limitations of claim 1 as discussed above.
Chomas further teaches following limitations:
marking a dimple to be treated at the first treatment site (a physician applies a reference mark to the dermis to identify a cellulite dimple for a treatment [0190])
marking the instrument insertion location (entry hole [0019], [0084], capturing dimpled cellulite into the recessed portion of the handpiece [0192]);
advancing the deployable pull-back cutter below the skin generally parallel to the surface of the skin or angles with respect thereto toward a marked dimple (conduit will penetrate into the tissue disposed within the recessed area, substantially parallel to the surface of the tissue [0087])
deploying a cutting blade of the instrument at the first/second treatment site (cutting blade is slidably disposed within sleeve[0093], cutting blades of the cutting tool is deployed [0195]); and
retracting the cutting blade to cut a septum associated with the dimple at the first/second treatment site(cut the fibrous septa [0031], [0073], reciprocating cutting blade [0091]-[0092], cutting tool is moved in a forward and reverse direction [0196])
Chomas does not further explicitly disclose marking dimples “while a patient is standing,” and “observing transillumination, from a transillumination through the skin from an illuminating source on the instrument, through the skin while advancing the instrument to the first treatment site” as claimed.
However, in the same field of a cellulite treatment, Knowlton 251 teaches advancing the tool to dissect fibrous septa to correct cellulite ([0249]), and the tool includes a transcutaneous visualization with LED integral or attached to the tool to transilluminate through the skin to provide the physician with a real time indication of the tissue flap thickness and dissection depth ([0251]-[0255]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the deployable cutting tool as taught by Chomas to incorporate teaching of Knowlton 251, since cutting tool with visualization structure was well known in the art of dissecting and treating cellulite as taught by Knowlton 251. One of ordinary skill in the art could have combined the elements as claimed by cutter with no change in their respective functions, but add/integrate with LED to the device housing, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide real time monitoring of the tissue dissection ([0253]), and there was reasonable expectation of success.
Knowlton 521 further discloses patient is in a standing position (Figures 54A-B), but does not state that dimple is marked while the patient is standing, the examiner submits that dimples are usually evaluated while the patient is in upright position and provides “Hart” to support that it is well known in the art to measure dimple in a standing patient.
In a same field of endeavor in treating or reducing cellulite, Hart teaches that dimples are visually evident when the patient is standing ([0021]), and marking an instrument insertion location ([0053]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify marking the dimples as taught by Chomas to incorporate teaching of Hart, since assessing dimples while patient is standing was well known in the art as taught by Hart. One of ordinary skill in the art could have combined the elements as claimed by Chomas with no change in their respective functions, performing the marking the dimples while the patient is standing as taught by Hart, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to visual assessment of the treatment areas ([0021]), and provides visual assessment of treatment area without manipulation ([0047]) and there was reasonable expectation of success.
Regarding to claims 5, Chomas, Knowlton, Knowlton 251, and Hart together teach all limitations of claim 2 as discussed above.
Chomas further teaches following limitations:
Of claim 5, wherein the instrument has a linkage which pushes the cutting blade generally parallel to the surface of the skin (Figures 18, 19A-C, blades are pivotally associated with the tool [0142]-[0143], [0147], [0149]), and generally perpendicular to septa (Figures 27A-D show piercing perpendicularly to the septa, [0212])
Regarding to claim 6, Chomas, Knowlton, and Hart together teach all limitations of claim 2 as discussed above.
Knowlton further teaches following limitations wherein the illuminating source is a light emitting diode (LED [0251]).
Regarding to claims 3, Chomas, Knowlton, Knowlton 251, and Hart together teach all limitations of claim 2 as discussed above.
Hart further teaches following limitations:
Of claim 3, wherein the dimple at the first treatment site is marked with a circle ([0013] and [0051] Figure 1 dimple is marked with circle)
Regarding to claims 14-15, claims 14-15 are rejected in the same manner as claims 2-3 as set forth above, as the examiner notes that Knowlton already disclosed first and second treatment sites as buttocks and thighs, and same rejection applied to the limitations and can be applied to first and second treatment sites.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chomas, Knowlton, and Hart as applied to claim 2 above, and further in view of “Clark, III et al.,” US 2014/0257272 (hereinafter Clark, III).
Regarding to claim 8, Chomas, Knowlton, and Hart together teach all the limitations of claim 2 as discussed above.
Chomas does disclose a squeezing tool on the dimples (vacuum, suction [0082]), but does not disclose using the tool after the treatment effect confirmation as claimed.
However, in the same field of endeavor in cellulite treatment, Clark, III teaches using a squeezing tool on the treated dimple as a post procedural treatment ([0275]-[0276] Figures 37A-B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify vacuuming the dimples as taught by Chomas to incorporate teaching of Clark, III, since post procedural vacuum treatment was well known in the art as taught by Clark, III. One of ordinary skill in the art could have combined the vacuuming the tissue as claimed by Chomas with no change in their respective functions, by performing post procedural vacuuming the dimples and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to reduce re-depression ([0275]), and improve healing ([0275]), and there was reasonable expectation of success.
Claims 9-10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Chomas, Knowlton, Knowlton 251, and Hart as applied to claim 2 above, and further in view of “Davidson et al.,” US 2018/0250217 (hereinafter Davidson).
Regarding to claims 9-10 and 16, Chomas, Knowlton, Knowlton 521, and Hart together teach all limitations of claim 2 as discussed above.
In the analogous field of endeavor in cellulite treatment, Davidson teaches following limitations:
Scanning the skin of the patient, using a scanner associated with a computerized controller (computer generated images [0055]), to identify the dimple at the first treatment site (Figures 2A-E, 4A-E, 5A-E [0208], [0212], [0213]-[0215]); and
Storing pre-treatment scanning data (pre-treatment and post-treatment images are shown side by side [0234]; [0281]-[0284]);
Scanning the skin of the patient to generate after-treatment data (pre-treatment and post-treatment images are shown side by side [0234]; [0281]-[0284]); and
Comparing the pre-treatment scanning data to the after-treatment data (Figure 6B and Figures 10A-B, pre-treatment and post-treatment images are shown side by side [0234]; [0281]-[0284])
Although, Davidson does not explicitly teach storing the data, the examiner submits that computerized controller is equipped with memory system, supported by Knowlton 251 ([0308] and [0309]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify vacuuming the dimples as taught by Chomas to incorporate teaching of Davidson, since scanning target with pre and post treatment was well known in the art as taught by Davidson. One of ordinary skill in the art could have combined the vacuuming the tissue as claimed by Chomas with no change in their respective functions, by using the scanning device to provide pre and post treatment images, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to assessment for treatment ([0281]-[0284]) and there was reasonable expectation of success.
Regarding to claim 16, Chomas, Knowlton, Knowlton 521, and Hart in combination of Davidson together teach all limitations of claim 9 as discussed above.
Claim 16 is rejected in the same manner as claim 9, as Knowlton discloses first and second treatment site to be buttocks and thighs, and same rejection applied to the limitations and can be applied to first and second treatment sites.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schwarz (US 10,549,110) teaches that the treatment location is gluteal sulcus (gluteal fold) (Col. 34 lines 44-51, Figure 15).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICIA J PARK whose telephone number is (571)270-1788. The examiner can normally be reached on Monday-Thursday 8 am - 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal M Bui-Pho can be reached on 408-918-9701. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICIA J PARK/Primary Examiner, Art Unit 3793
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