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 .
Reissue Applications
Applicant is reminded of the continuing obligation under 37 CFR § 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which US Pat. No. 11,229,575 (hereinafter “the ‘575 patent”) is or was involved. These proceedings would include interferences, reissues, reexaminations and litigations.
Applicant is further reminded of the continuing obligation under 37 CFR § 1.56 to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Maintenance Fees
Review of the file indicates that the 3.5 year maintenance fees for the ‘575 patent were paid on 06/12/2025.
Reissue Declaration
MPEP § 1414 (II) states,
(A) A reissue applicant must acknowledge the existence of an error in the specification, drawings, or claims, which error causes the original patent to be defective. In re Wilder, 736 F.2d 1516, 222 USPQ 369 (Fed. Cir. 1984). A change or departure from the original specification or claims represents an "error" in the original patent under 35 U.S.C. 251. See MPEP § 1402 for a discussion of grounds for filing a reissue that may constitute the "error" required by 35 U.S.C. 251. Not all changes with respect to the patent constitute the "error" required by 35 U.S.C. 251. It is noted that an error to be corrected under 35 U.S.C. 251 may be the addition of a claim or claims that is/are narrower in scope than the existing patent claims, without any narrowing of the existing patent claims. See In re Tanaka, 640 F.3d 1246, 1251, 98 USPQ2d 1331, 1334 (Fed. Cir. 2011).
(B) Applicant need only specify in the reissue oath/declaration one of the errors upon which reissue is based. Where applicant specifies one such error, this requirement of a reissue oath/declaration is satisfied. Applicant may specify more than one error and examiners should not object that more than one error is specified in the reissue oath/declaration.
For an application filed on or after September 16, 2012 that seeks to enlarge the scope of the claims of the patent, the reissue oath or declaration must also identify a claim that the application seeks to broaden in the identification of the error that is relied upon to support the reissue application. A general statement, e.g., that all claims are broadened, is not sufficient to satisfy this requirement. In specifically identifying the error as required by 37 CFR 1.175(a), it is sufficient that the reissue oath/declaration identify the claim being broadened and a single word, phrase, or expression in the specification or in an original claim, and how it renders the original patent wholly or partly inoperative or invalid. The corresponding corrective action which has been taken to correct the original patent need not be identified in the oath/declaration. (emphasis added).
The reissue declaration filed with this application is defective because it fails to identify the error which is relied upon to support the reissue application. See 37 CFR 1.175 and MPEP § 1414. This reissue application seeks to enlarge the scope of the claims by checking the box indicating “by reasons of the patentee claiming more or less than he had the right to claim in the patent.” Additionally, applicant states in their remarks filed 01/24/2024 “in this broadening reissue application.” See Remarks filed 10/24/2024, p. 12, ll. 3-4. Therefore, applicant must file a new Reissue Declaration including an error statement identifying the error in the claims, i.e. at least one word, and the claim # containing that error.
Claim Rejections - 35 USC § 251 - Reissue Declaration
The following is a quotation of the first paragraph of 35 U.S.C. 251:
(a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.
Claims 1-48 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect in the declaration is set forth in the discussion above in this Office action.
Response to Amendment
The amendment to the specification filed on 01/24/2024 is objected to as not complying with the requirements of 37 CFR 1.173 (d)(1)&(2) because each change relative to the ‘575 patent has not been properly marked. 37 CFR (d)(1)&(2) state:
(d) Changes shown by markings. Any changes relative to the patent being reissued which are made to the specification, including the claims, upon filing, or by an amendment paper in the reissue application, must include the following markings:
(1) The matter to be omitted by reissue must be enclosed in brackets; and
(2) The matter to be added by reissue must be underlined, except for amendments submitted on compact discs (§§ 1.96 and 1.821(c)). Matter added by reissue on compact discs must be preceded with “<U>” and end with “</U>” to properly identify the material being added.
The amendment to the specification in the amendment filed 01/24/2024 does not underline the new additions with respect to the original patent specification.
These corrections should be submitted with the next correspondence.
Election/Restrictions
Newly submitted claim 48 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: independent claim 48 is directed to the subcombination of a probe.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 48 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should 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. In either instance, 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.
I. Claims 1-47, drawn to an apparatus/system or method to reduce subcutaneous fat or induce inflammation of subcutaneous adipose tissue in a treatment area, classified in A61N2007/0008.
II. Claim 48, drawn to a probe for delivering a plurality of pressure waves to an external area of a patient, classified in A61N2007/0091.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the combination does not require at least a cylindrical portion configured to extends through an opening along the spark head into the chamber. The subcombination has separate utility such as utility by itself and not part of a larger apparatus, system or method. Additionally, the subcombination could be used in another combination that uses a different pulse rate than the one claimed and disclosed for the claimed apparatus/system or method to reduce subcutaneous fat or induce inflammation of subcutaneous adipose tissue in a treatment area of Group I.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: a serious examination burden as evidenced by, for example, non-prior art issues relevant to one invention that are not relevant to the other invention. In this case, the subcombination requires an extensive search in the structure of the probe that is not required for the probe claimed in the combination.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should 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. In either instance, 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).
Claim Objections
Claims 26 and 38 are objected to because of the following informalities:
In claim 26, “comprising” occurs twice in succession on line 3.
In claim 38, “the method comprising” occurs twice in succession on lines 3-4.
Appropriate correction is required.
Recapture
Claims 26-48 are rejected under 35 U.S.C. 251 as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based. In re McDonald, 43 F.4th 1340, 1345, 2022 USPQ2d 745 (Fed. Cir. 2022); Greenliant Systems, Inc. et al v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Shahram Mostafazadeh and Joseph O. Smith, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984). A broadening aspect is present in the reissue which was not present in the application for patent. The record of the application for the patent shows that the broadening aspect (in the reissue) relates to claimed subject matter that applicant previously surrendered during the prosecution of the application. Accordingly, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claim subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
As stated in M.P.E.P. § 1412.02,
In Clement, 131 F.3d at 1468-70, 45 USPQ2d at 1164-65, the Court of Appeals for the Federal Circuit set forth a three step test for recapture analysis. In North American Container, 415 F.3d at 1349, 75 USPQ2d at 1556, the court restated this test as follows:
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We apply the recapture rule as a three-step process:
(1) first, we determine whether, and in what respect, the reissue claims are broader in scope than the original patent claims;
(2) next, we determine whether the broader aspects of the reissue claims relate to subject matter surrendered in the original prosecution; and
(3) finally, we determine whether the reissue claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule.
In North American Container, the court cited Pannu, 258 F.3d at 1371, 59 USPQ2d at 1600; Hester, 142 F.3d at 1482-83, 46 USPQ2d at 1649-50; and Clement, 131 F.3d at 1468, 45 USPQ2d at 1164-65 as cases that lead to, and explain the language in, the North American Container recapture test.
Step 1: New independent claims 26, 38, 46 and 48 and their dependent claims are broader than original independent patent claims 1, 9 and 17 and their dependent claims.
New independent claim 26 does not include the claim limitation of “where the pressure wave generating probe is configured to emit the plurality of pressure waves each having an energy density of between 0.5 mJ per mm2 and 7.0 mJ per mm2 at the pressure wave outlet window” which was part of original independent patent claim 1.
New independent claim 38 does not include the claim limitation of “where the pressure wave generating probe is configured to emit the plurality of pressure waves each having an energy density of between 0.5 mJ per mm2 and 7.0 mJ per mm2 at the pressure wave outlet window” which was part of original independent patent claim 9.
New independent claim 46 does not include the claim limitation of “where the pressure wave generating probe is configured to emit the series of pressure waves at an energy density of between 2.0 mJ per mm2 and 7.0 mJ per mm2 at the shockwave outlet and induce no transient cavitation bubbles in a water-based medium” which was part of original independent patent claim 17.
Therefore step 1 of the three-step test is met for claims 26-47.
Step 2: In the prosecution of US Application 15/573,353, applicant relied upon the limitation of “where the pressure wave generating probe is configured to emit the series of pressure waves at an energy density of between 2.0 mJ per mm2 and 7.0 mJ per mm2 at the [shockwave/pressure wave] outlet” in order to gain allowance of the claims; this limitation is not included in new independent claims 26, 38 and 46 submitted for reissue.
In this case, Applicant argued in their response filed 11/02/2020 that “Uebelacker fails to disclose a device configured to ‘emit the series of pressure waves at an energy density of at least 2.0 mJ per mm2’ at the [shockwave/pressure wave] outlet.” See Response on page 8 of 10.
The claim language removed from claims 26-47 which resulted in the broadening of claims 26-47 is the exact claim language or related claim language of the surrendered subject matter by applicant.
Therefore, step 2 of the three-step test is met for claims 26-47.
Step 3: It is impermissible recapture for a reissue claim to be as broad as, or broader in scope than any claim that was canceled or amended in the original prosecution to define over the art. Claim scope that was canceled or amended is deemed surrendered and therefore barred from reissue. Clement, 131 F.3d at 1470, 45 USPQ2d at 1165. It must be determined whether the reissue claim omits or broadens any limitation that was added or argued during the original prosecution to overcome an art rejection. Such an omission in a reissue claim, even if it is accompanied by other limitations making the reissue claim narrower than the patent claim in other aspects, is impermissible recapture. Pannu, 258 F.3d at 1371-72, 59 USPQ2d at 1600. In any broadening reissue application, the examiner will determine, on a claim-by-claim basis, whether the broadening in the reissue application claim(s) relates to subject matter that was surrendered during the examination of the patent for which reissue is requested) by an amendment narrowing claim scope in order to overcome a rejection and/or argument relying on a claim limitation in order to overcome a rejection.
Claims 26-47 entirely eliminate the surrendered subject matter. During the prosecution of the ‘575 patent, Applicant specifically argued that the prior art did not disclose “where the pressure wave generating probe is configured to emit the series of pressure waves at an energy density of between 2.0 mJ per mm2 and 7.0 mJ per mm2 at the [shockwave/pressure wave] outlet.” Therefore, the Applicant is not permitted to remove this limitation without invoking impermissible recapture.
Therefore, step 3 of the three-step test is met for claims 26-47.
The omission of “where the pressure wave generating probe is configured to emit the series of pressure waves at an energy density of between 2.0 mJ per mm2 and 7.0 mJ per mm2 at the [shockwave/pressure wave] outlet” from new claims 26-47 invokes impermissible recapture of surrendered subject matter as detailed above by the three step test. Therefore, claims 26-47 are rejected under 35 U.S.C. 251 as indicated above.
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.
Claims 26-47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/917,971 (“the ‘971 application”) in view of WO 2011/006017 A1 to Cioanta et al. (hereinafter “Cioanta”).
18/421,864
18/917,971
Claim 26 (New)
Claim 1
A method of treating a patient to reduce subcutaneous fat in at least one treatment area, where fat comprises fat cells having intracellular fat and interstitial space between the fat cells, the method comprising:
A method of treating a patient comprising:
directing a pressure wave generating probe to a first treatment area of the patient; and
directing a pressure wave generating probe to a first treatment area of the patient; and
emitting a plurality of pressure waves to the first treatment area at a pulse rate of between 15Hz and 100Hz,
emitting a plurality of pressure waves to the first treatment area at a pulse rate of between 15Hz and 100Hz,
where the pressure wave generating probe is configured to emit the plurality of pressure waves each having an acoustic pressure amplitude between 0.5 to 50 MPa;
where the pressure wave generating probe is configured to emit the plurality of pressure waves each having an acoustic pressure amplitude between 0.5 to 50 MPa;
(see Claim 27 below)
where the plurality of pressure waves are directed to the first treatment area for a duration substantially between 60 and 240 seconds;
where the plurality of pressure waves are not focused prior to entering into the first treatment area of the patient.
where the plurality of pressure waves are not focused prior to entering into the first treatment area of the patient.
Claim 27
The method of claim 26, wherein the plurality of pressure waves are directed to the first treatment area for a duration substantially between 60 and 240 seconds.
(see Claim 1 above)
Claim 28
Claim 2
The method of claim 26, wherein the first treatment area includes an area of subcutaneous fat comprising fat cells having intracellular fat and interstitial space between the fat cells.
The method of claim 1, wherein the first treatment area includes an area of subcutaneous fat comprising fat cells having intracellular fat and interstitial space between the fat cells.
Claim 29
Claim 3
The method of claim 28, wherein the plurality of pressure waves are emitted at a pulse rate of substantially between 20 and 75 Hz.
The method of claim 2, wherein the plurality of pressure waves are emitted at a pulse rate of substantially between 20 and 75 Hz.
Claim 30
Claim 4
The method of claim 26, further comprising: directing the pressure wave generating probe to a second treatment area emitting a plurality of pressure waves to the second treatment area at a pulse rate of substantially between 15 Hz and 100 Hz: and where the plurality of pressure waves are directed to the second treatment area for a duration substantially between 60 and 240 seconds.
The method of claim 1, further comprising: directing the pressure wave generating probe to a second treatment area emitting a plurality of pressure waves to the second treatment area at a pulse rate of substantially between 15 Hz and 100 Hz: and where the plurality of pressure waves are directed to the second treatment area for a duration substantially between 60 and 240 seconds.
Claim 31
Claim 5
The method of claim 30, wherein the second treatment area includes an area of subcutaneous fat comprising fat cells having intracellular fat and interstitial space between the fat cells.
The method of claim 4, wherein the second treatment area includes an area of subcutaneous fat comprising fat cells having intracellular fat and interstitial space between the fat cells.
Claim 32
Claim 6
The method of claim 31, further comprising directing at least a portion of the plurality of pressure waves to the first treatment area and the second treatment area such that delivery of the at least a portion of the plurality of pressure waves to the first and second treatment areas reduces the appearance of cellulite in the treatment areas.
The method of claim 5, further comprising directing at least a portion of the plurality of pressure waves to the first treatment area and the second treatment area such that delivery of the at least a portion of the plurality of pressure waves to the first and second treatment areas reduces the appearance of cellulite in the treatment areas.
Claim 33
Claim 7
The method of claim 26, wherein: pressure wave generating probe comprises a pressure wave outlet window, where the pressure wave generating probe is configured to emit the plurality of pressure waves each having an energy density of less than 2.0 mJ per mm2 at the pressure wave outlet window.
The method of claim 1, wherein: pressure wave generating probe comprises a pressure wave outlet window, where the pressure wave generating probe is configured to emit the plurality of pressure waves each having an energy density of less than 2.0 mJ per mm2 at the pressure wave outlet window, and
Claim 34
Claim 8
The method of claim 33, further comprising applying the plurality of pressure waves to an adipose tissue in the first treatment area at: a pulse rate of between 25 and 500 HZ; and an energy density of between 0.5 and 2.0 mJ per mm2 per pressure wave.
The method of claim 7, further comprising applying the plurality of pressure waves to an adipose tissue in the first treatment area at: a pulse rate of between 25 and 500 HZ; and an energy density of between 0.5 and 2.0 mJ per mm2 per pressure wave.
Claim 35
Claim 9
The method of claim 34, where the plurality of pressure waves emitted by the pressure wave generating probe induce no adipose cell damage when treating the first treatment area.
The method of claim 8, where the plurality of pressure waves emitted by the pressure wave generating probe induce no adipose cell damage when treating the treatment area.
Claim 36
Claim 10
The method of claim 26, where the plurality of pressure waves do not induce transient cavitation in an aqueous solution of the pressure wave generating probe.
The method of claim 1, where the plurality of pressure waves do not induce transient cavitation in an aqueous solution of the pressure wave generating probe.
Claim 37
Claim 11
The method of claim 33, where: the plurality of pressure waves include a pressure wave energy of between 0.50 and 7.0 mJ per mm2 at the pressure wave outlet window, and the pressure wave outlet window has an area of between 0.5 and 20 mm2.
The method of claim 1, where: the plurality of pressure waves include a pressure wave energy of between 0.50 and 7.0 mJ per mm2 at the pressure wave outlet window, and the pressure wave outlet window has an area of between 0.5 and 20 mm2.
Claim 38
Claim 12
A method of inducing inflammation of subcutaneous adipose tissue in a treatment area of a patient to reduce subcutaneous fat in the treatment area, where fat comprises fat cells having intracellular fat and interstitial space between the fat cells, the method comprising, the method comprising:
A method of inducing inflammation of subcutaneous adipose tissue in a treatment area of a patient, the method comprising:
directing a pressure wave generating probe to an external treatment area of the patient; and
directing a pressure wave generating probe to an external treatment area of the patient; and
emitting a plurality of pulses to the treatment area, each pulse including a plurality of pressure waves at a rate of between 15 Hz and 100 Hz;
emitting a plurality of pulses to the treatment area, each pulse including a plurality of pressure waves at a rate of between 15 Hz and 100 Hz;
(see Claim 39 below)
wherein a time period between pulses of is substantially between 0.5 to 50 microseconds
(see Claim 26 and 27 above)
where the plurality of pulses are directed to the treatment area for a duration substantially between 60 and 240 seconds;
where the plurality of pressure waves are not focused prior to entering into the treatment area of the patient.
where the plurality of pressure waves are not focused prior to entering into the treatment area of the patient.
Claim 39
The method of claim 38, wherein a time period between pulses is substantially between 0.5 to 50 microseconds;
(see Claim 12 above)
Claim 40
Claim 13
The method of claim 38, where: the pressure wave generating probe comprises a pressure wave outlet window, and the pressure wave generating probe is configured to emit the plurality of pressure waves having between 0.5 and 7.0 mJ per mm2 at the pressure wave outlet window.
The method of claim 12, where: the pressure wave generating probe comprises a pressure wave outlet window, and the pressure wave generating probe is configured to emit the plurality of pressure waves having between 0.5 and 7.0 mJ per mm2 at the pressure wave outlet window.
Claim 41
Claim 14
The method of claim 38, where the plurality of pulses are applied to the treatment area at a pulse energy of 4.6 Joules per pulse.
The method of claim 12, where the plurality of pulses are applied to the treatment area at a pulse energy of 4.6 Joules per pulse.
Claim 42
Claim 15
The method of claim 38, where each of the plurality of pressure waves includes a rise time of less than 20 nanoseconds.
The method of claim 12, where each of the plurality of pressure waves includes a rise time of less than 20 nanoseconds.
Claim 43
Claim 16
The method of claim 38, where the plurality of pressure waves have an acoustic pressure amplitude between 0.5 to 50 MPa.
The method of claim 12, where the plurality of pressure waves have an acoustic pressure amplitude between 0.5 to 50 MPa.
Claim 44
Claim 17
The method of claim 38, where the treatment area is within a depth of 6 cm from a surface of the treatment area, and where the treatment area is a butt, thigh, stomach, waist, upper arm area, or a portion thereof.
The method of claim 17, where the treatment area is within a depth of 6 cm from a surface of the treatment area, and where the treatment area is a butt, thigh, stomach, waist, upper arm area, or a portion thereof.
Claim 45
Claim 18
The method of claim 38, where the plurality of pressure waves emitted from the pressure wave generating probe comprise substantially planar pressure waves.
The method of claim 9, where the plurality of pressure waves emitted from the pressure wave generating probe comprise substantially planar pressure waves.
Claim 46
Claim 19
Acoustic shockwave generation system configured to reduce subcutaneous fat in a treatment area, where fat comprises fat cells having intracellular fat and interstitial space between the fat cells, the system comprising:
Acoustic shockwave generation system configured to reduce subcutaneous fat in a treatment area, where fat comprises fat cells having intracellular fat and interstitial space between the fat cells, the apparatus comprising:
a pressure wave generating probe configured to deliver a plurality of pressure waves to an external area of the patient, the pressure wave generating probe comprising:
a pressure wave generating probe configured to deliver a plurality of pressure waves to an external area of the patient, the pressure wave generating probe comprising:
a housing defining a chamber and a shockwave outlet, the chamber configured to be filled with a liquid; and
a housing defining a chamber and a shockwave outlet, the chamber configured to be filled with a liquid; and
a plurality of electrodes disposed in the chamber to define one or more spark gaps;
a plurality of electrodes disposed in the chamber to define one or more spark gaps;
where the pressure wave generating probe is configured to emit the plurality of pressure waves at a pulse rate of between 15 Hz and 1000 Hz;
where the pressure wave generating probe is configured to emit the plurality of pressure waves at a pulse rate of between 15 Hz and 1000 Hz;
where the pressure wave generating probe is configured to emit the plurality of pressure waves each having an acoustic pressure amplitude between 0.5 to 50 MPa;
where the pressure wave generating probe is configured to emit the plurality of pressure waves each having an acoustic pressure amplitude between 0.5 to 50 MPa;
where the plurality of pressure waves are not focused prior to entering into the first treatment area of the patient.
where the plurality of pressure waves are not focused prior to entering into the first treatment area of the patient.
Claim 47
Claim 20
The system of claim 44, where the pressure wave generating probe is configured to emit the plurality of pressure waves at an energy density of between 0.5 and 7.0 mJ per mm2 at the shockwave outlet and induce no transient cavitation bubbles in a water-based medium, and where a pressure wave outlet window associated with the shockwave outlet has an area of 0.5 cm2 to 20 cm2.
The system of claim 19, where the pressure wave generating probe is configured to emit the plurality of pressure waves at an energy density of between 0.5 and 7.0 mJ per mm2 at the shockwave outlet and induce no transient cavitation bubbles in a water-based medium, and where a pressure wave outlet window associated with the shockwave outlet has an area of 0.5 cm2 to 20 cm2.
Claims 26-47 are substantially identical to claims 1-20 of the ‘971 application except for the additional limitation of “to reduce subcutaneous fat in at least one treatment area, where fat comprises fat cells having intracellular fat and interstitial space between the fat cells” in the preamble of independent claims 26 and 38. However, this limitation is obvious in light of the teachings of Cioanta which discloses using shockwaves in order to reduce subcutaneous fat. See para. [00251] stating, “Use of extracorporeal pressure shock waves may also be used for cellulite, body sculpting, skin rejuvenation, "spider veins", burns, acute and chronic wounds, scar tissue, lymph-edema and enhancement of collateral blood flow. Pressure shock waves can be used to liquefy fat (adipose tissue), which then can be pushed together with cellular debris into lymphatic system due to the pressure gradient created by the pressure shock waves.”
Additionally, it is necessarily inherent that fat cells have intracellular fat and adipose tissue has interstitial space between the fat cells since this cellular organization is a product of nature and necessarily occurs in subcutaneous fat/adipose tissue.
This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 7, 9, and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cioanta in view of WO2011/089270 to Voss (hereinafter “Voss”).
Regarding claims 1 and 9, Cioanta teaches a method of treating a patient to reduce subcutaneous fat / inducing inflammation of subcutaneous tissue in a treatment area (see para. [00251] stating, “Use of extracorporeal pressure shock waves may also be used for cellulite, body sculpting, skin rejuvenation, "spider veins", burns, acute and chronic wounds, scar tissue, lymph-edema and enhancement of collateral blood flow. Pressure shock waves can be used to liquefy fat (adipose tissue), which then can be pushed together with cellular debris into lymphatic system due to the pressure gradient created by the pressure shock waves.”), where fat comprises fat cells having intracellular fat and interstitial space between the fat cells (it is considered necessarily inherent that fat cells have intracellular fat and adipose tissue has interstitial space between the fat cells since this cellular organization is a product of nature and necessarily occurs in subcutaneous fat tissue), the method comprising: directing a pressure wave generating probe to an external treatment area of the patient (see Fig. 27A); and emitting a plurality of pressure waves to the treatment area at a pulse rate of between 15 Hz and 1000 Hz (see para. [0006] for disclosure of 15Hz), where the pressure wave generating probe comprises a pressure wave outlet window (junction between the probe 30 and skin 28; see Fig. 27A), where the pressure wave generating probe is configured to emit the plurality of pressure waves each having an energy density of between 0.5 mJ per mm2 and 7.0 mJ per mm2 at the pressure wave outlet window (see para. [0003] stating, “As used herein, High Energy pressure shock waves generate a flux density higher than 0.3 mJ/mm2”.), and where the plurality of pressure waves are not focused prior to entering into the treatment area of the patient (see paras. [00147] and [00434]).
Cioanta meets the claim limitations as described above but fails to specifically disclose the pressure waves having an energy density of between 0.5 mJ per mm2 and 7.0 mJ per mm2. However, Voss teaches a medical device for lipolysis treatment (disintegration of subcutaneous adipose tissue) to induce the release of stored fat from adipocytes (fat cells). See p. 4. As stated on page 6, “The method may include the additional step of activating an ultrasonic treatment head for introducing ultrasonic energy into human tissue, preferably an ultrasonic head for performing a lipolysis treatment on a patient, preferably emitting ultrasonic waves of an intensity of about 3 W/sqcm and/or at a frequency of between 0.9 and 4 MHz and/or a pressure wave applicator emitting high intensity pressure waves, preferably of an intensity of about 0.01 mJ/sqmm to 1.5 mJ/sqmm.”
At the effective time of filing, it would have been obvious to one of ordinary skill in the art to incorporate the teaching of the energy density of 1.5 mJ/mm2 as taught by Voss into the invention of Cioanta. Cioanta teaches a high energy pressure shock wave of a flux density higher than 0.3 mJ/mm2 but does not provide a specific value. Voss provides a specific range of an energy density which is missing from Cioanta; and therefore, one skilled in the art would have been motivated to incorporate the disclosed density of Voss into the invention of Cioanta. Further, one would have expected predictable results since 1.5mJ/mm2 is higher than 0.3mJ/mm2 which is specified by Cioanta.
Regarding claim 3, Cioanta teaches the method of claim 1 and further discloses directing at least a portion of the plurality of pressure waves to the treatment area such that delivery of the at least a portion of the plurality of pressure waves to the treatment area reduces the appearance of cellulite in the treatment area (see page 6 stating on lines 1-2, “cosmetic treatments based on destroying the fat cells and pushing them into lymphatic system for elimination (cellulite, body sculpting, etc.)”).
Regarding claim 7, Cioanta teaches the method of claim 1 and further discloses where the plurality of pressure waves emitted by the pressure wave generating probe cause a volume loss of the treatment area. See para. [00251] “Use of extracorporeal pressure shock waves may also be used for cellulite, body sculpting, skin rejuvenation, "spider veins", burns, acute and chronic wounds, scar tissue, lymph-edema and enhancement of collateral blood flow. Pressure shock waves can be used to liquefy fat (adipose tissue), which then can be pushed together with cellular debris into lymphatic system due to the pressure gradient created by the pressure shock waves.”
Regarding claim 11, Cioanta teaches the method of claim 9 and further discloses where the treatment area is within a depth of 6 cm from a surface of the treatment area, and where the treatment area is a butt, thigh, stomach, waist, upper arm area, or a portion thereof. See para. [00260] stating, “The treatment area for various conditions can be found at different depths relative to the skin 28. Exemplary penetration depth of pressure shock waves for cellulite, skin rejuvenation, wound healing, scars and "spider veins" is only superficial in the order of 1 - 30 mm.” and para. [00458] stating, “Embodiments of the invention can be used in non- limiting examples on the torso, buttocks and for the front of body 27.”
Regarding claim 12, Cioanta teaches the method of claim 9 and further discloses where the plurality of pressure waves emitted from the pressure wave generating probe comprise substantially planar pressure waves. See Cioanta Claim 10.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE SERKE WILLIAMS whose telephone number is (571)272-4970. The examiner can normally be reached Monday through Friday core hours 8am-4pm ET.
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/CATHERINE S WILLIAMS/Reexamination Specialist, Art Unit 3993
Conferees:
/Laura Davison/Reexamination Specialist, Art Unit 3993
/Patricia L Engle/SPRS, Art Unit 3993