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 .
Response to Amendment
This office action is in response to amendment filed on 01/02/2026. As directed by the amendment, claim 1 was canceled, claims 2, 13, and 21 were amended, and no claims were newly added. Thus, claims 2-21 are presently pending in this application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “wherein at least two of the plurality of head pressure applying regions extend in different directions relative to one another” of claim 13 lines 6-7 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13-20 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.
Regarding claim 13 lines 6-7, the term “wherein at least two of the plurality of head pressure applying regions extend in different directions relative to one another” is unclear as to how the head garment portion (120; Figs. 1 and 7) comprising head pressure applying regions (121) is extending two different directions or how the regions as claimed would extend. It appears, from Fig. 7, that the head pressure applying regions (121) are in a continuous line. Is the neck garment portion (110) intended to be a part of this different directionality claim?
Any remaining claims are rejected as being dependent upon a rejected base claim.
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 2-3, 7, 9-14 and 16-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of Chase (11,944,585).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application claims recite additional features not present in the patent claims.
Regarding application claim 2, the following comparison between the patent claims and the application claim, see underlined features in the patent claims, show what elements have been excluded in the presentation of the application claim.
Patent claim 2
Application claim 2
1. A compression garment comprising: a head garment configured to be positioned around both sides of a head of a body from a posterior of the head to an anterior of the head,
wherein the head garment comprises a plurality of controllable head pressure applying regions positionable proximate at least cheeks and a posterior of the head,
each of the plurality of controllable head pressure applying regions comprising one or more cells configured to receive a fluid,
wherein, during use, one cell of the one or more cells of the head garment extends forward from a posterior portion of the head garment toward a forward portion of the head garment, and further angles downward from the forward portion of the head garment to a cheek portion of the head garment,
the head garment further comprising a forehead garment portion positionable proximate a forehead of the head, wherein the forehead garment portion comprises one or more forehead connection straps configured for use in donning the head garment on the head.
2. The compression garment of claim 1, wherein the compression garment is controllable by a controller configured to control each of the plurality of controllable head pressure applying regions to apply pressure to the cheeks and the posterior of the head to move lymph at least from the cheeks towards a neck of the head.
2. A method of lymphedema treatment of a head and a neck using compression therapy utilizing a head garment including a plurality of head pressure applying regions of comprising:
moving lymph from a cheek of the head of a lymphedema patient towards a posterior of the head and from the posterior of the head towards the neck of the lymphedema patient by controlling pressure applied to the head of the body using the plurality of head pressure applying regions of the head garment to reduce localized fluid retention and tissue swelling of the head of the lymphedema patient, at least a portion of the plurality of head pressure applying regions positioned in a pattern radiating away from a face of the head toward the posterior of the head.
Thus, it is apparent, for the broadening aspect, that patent claim 2 includes features that are not in application claim 2, where patent claim 2 includes everything as claimed, see the table above, and where patent claim 2 and instant application claim 2 differ by reciting the underlined features.
Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Since instant application claim 2 is anticipated by patent claim 2, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then instant application claim 2 is obvious over patent claim 2 with respect to the broadening aspect.
Regarding application claim 3, patent claim 2 reads on the application claim.
Regarding application claim 7, patent claim 2 reads on the application claim.
Regarding application claim 9, patent claim 2 reads on the application claim.
Regarding application claim 10, patent claim 2 reads on the application claim.
Regarding application claim 11, patent claim 2 reads on the application claim.
Regarding application claim 12, patent claim 2 reads on the application claim.
Regarding application claim 13, patent claim 2 reads on the application claim.
Regarding application claim 14, patent claim 2 reads on the application claim.
Regarding application claim 16, patent claim 2 reads on the application claim.
Regarding application claim 17, patent claim 2 reads on the application claim.
Regarding application claim 18, patent claim 2 reads on the application claim.
Regarding application claim 19, patent claim 2 reads on the application claim.
Regarding application claim 20, patent claim 2 reads on the application claim.
Regarding application claim 21, patent claim 2 reads on the application claim.
Claims 2-3, 7, 10, 13-14 and 18-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of Chase (11,154,452) in view of Rosett (1,795,893) and Waldridge (2003/0032905).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application claims recite additional features not present in the patent claims.
Regarding application claim 2, the following comparison between the patent claims and the application claim, see underlined features in the patent claims, show what elements have been excluded in the presentation of the application claim.
Patent claim 1
Application claim 2
1. A compression garment system comprising:
a head and torso garment comprising:
a plurality of head pressure applying regions controllable to apply pressure to a plurality of portions of a head of a body,
wherein the plurality of head pressure applying regions are positioned in a concentric pattern radiating away from a face of the head of the body to apply pressure to the plurality of portions of the head of the body to move lymph from portions of the head proximate the face to a neck of the body, and
a plurality of torso pressure applying regions controllable to apply pressure to a plurality of portions of a torso of the body; and
a controller operably coupled to the head and torso garment to control pressure applied by the plurality of head pressure applying regions and the plurality of torso pressure applying regions in at least a preparation phase and a drainage phase, wherein, when in the preparation phase, the controller is configured to apply pressure to the plurality of portions of the torso and the plurality of portions of the head using the plurality of torso pressure applying regions and the plurality of head pressure applying regions to prepare the torso of the body for lymph to be drained from the head the neck of the body,
wherein, when in the drainage phase, the controller is configured to apply pressure to the plurality of portions of the torso and the plurality of portions of the head using the plurality of torso pressure applying regions and the plurality of head pressure applying regions to move lymph at least from the head to the neck to the torso.
2. A method of lymphedema treatment of a head and a neck using compression therapy utilizing a head garment including a plurality of head pressure applying regions comprising:
moving lymph from a cheek of the head of a lymphedema patient towards a posterior of the head and from the posterior of the head towards the neck of the lymphedema patient by controlling pressure applied to the head d of the lymphedema patient using the plurality of head pressure applying regions of the head garment to reduce localized fluid retention and tissue swelling of the head of the lymphedema patient, at least a portion of the plurality of head pressure applying regions positioned in a pattern radiating away from a face of the head toward the posterior of the head.
Thus, it is apparent, that patent claim 1 includes features that are not in application claim 2, where patent claim 1 includes everything as claimed, see the table above, and where patent claim 1 and instant application claim 2 differ by reciting the underlined features.
With respect to the features recited in application claim 2 not recited in patent claim 1, patent claim 1 discloses moving lymph from portions of the head proximate the face to a neck of the body, see the table above, but is silent with regard to moving lymph from a cheek of a head of a lymphedema patient towards a posterior of the head and from the posterior of the head towards a neck of the lymphedema patient.
However, Rosett teaches that a plurality of head pressure applying regions of a head garment (defined by a hood having head pressure applying regions defined by top section A, cheek section B, and neck section C, see fig. 1; the head garment is pressurized to apply compression to the head of the user, see lines 70-85 of page 2) includes:
exerting pressure waves on tissues of the user to direct the flow of venous blood and lymphatic fluids away from the cheeks to the neck of the user via a plurality of pressure applying regions along the cheeks and neck of the head, see figs. 1 and 4-5 and see lines 99-122 of page 2.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided patent claim 1’s head garment with a plurality of pressure applying regions along the cheeks and neck of the head, as taught by Rosett, for the purpose of allowing the head garment to focus compression therapy along the cheeks and neck of the head, see figs. 1 and 4 of Rosett.
Additionally, Waldridge teaches that the compression garment (see fig. 1 and the abstract) includes the controller 14 being programmable to individually and sequentially pressurize and depressurize each of the plurality of pressure applying regions 24/26/28/30/32/34/36/38/40/42 (see fig. 1) in the desired sequence, see paras. [0048] and [0067], where pressurization is able to be along or opposite the directions, see fig. 1 and paras. [0049] and [0067], and where the controller 14 is programmed to apply pressure to pressure applying regions 24/26/28/30/32/34/36/38/40/42 to move lymph along the body of the user, see paras. [0048], on a patient specific basis for optimal therapeutic effect, see para. [0067] and [0051], and, therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided patent claim 1’s head garment with a controller, as taught by Waldridge, for the purpose of allowing a user to set a desired sequence and direction of pressurization/depressurization to achieve a desired therapeutic effect, see para. [0048] of Waldridge.
Modified patent claim 1 discloses all the structure as claimed and further discloses a method of compression therapy comprises a step of moving lymph from a cheek of a head of a lymphedema patient towards a posterior of the head and from the posterior of the head towards a neck of the lymphedema patient by controlling pressure applied to the head of the body using the plurality of head pressure applying regions of the head garment (the controller 14 being programmed to sequentially pressurize and depressurize each of a plurality of pressure applying regions, see the table for patent claim 1 above, in a desired sequence and direction, see fig. 1 and paras. [0048]-[0049] and [0067] of Waldridge; such that the controller 14 is able to be programmed to include a sequence of moving lymph from a cheek of a head of a body towards a posterior of the head and a sequence of from the posterior of the head towards a neck of the body).
Since instant application claim 2 is anticipated by patent claim 1, and since anticipation is the epitome of obviousness, then instant application claim 2 is obvious over patent claim 1.
Regarding application claim 3, patent claim 1 reads on the application claim.
Regarding application claim 7, patent claim 1 reads on the application claim.
Regarding application claim 10, patent claim 1 reads on the application claim.
Regarding application claim 13, patent claim 1 reads on the application claim.
Regarding application claim 14, patent claim 1 reads on the application claim.
Regarding application claim 18, patent claim 1 reads on the application claim.
Regarding application claim 19, patent claim 1 reads on the application claim.
Regarding application claim 20, patent claim 1 reads on the application claim.
Regarding application claim 21, patent claim 1 reads on the application claim.
Claims 2-3, 7, 10, 13-14 and 18-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of Wennen (11,376,184) in view of Rosett (1,795,893) in view of Waldridge (2003/0032905).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application claims recite additional features not present in the patent claims.
Regarding application claim 2, the following comparison between the patent claims and the application claim show what elements have been excluded in the presentation of the application claim.
Patent claim 2
Application claim 2
1. A compression garment system comprising:
a garment configured to be donned on a head and a neck of a body, wherein the garment comprises:
one or more forehead connection straps configured for use in donning the garment on the head of the body, a static garment portion configurable to apply a static pressure to a portion of the head during a compression therapy period, and
a dynamic garment portion comprising one or more pressure applying regions controllable to apply pressure to the head and neck,
wherein the one or more pressure applying regions comprises one or more cells configured to receive a fluid to apply pressure; and
a controller configured to control pressure applied by the one or more pressure applying regions to one or more portions of the head and neck during the compression therapy period.
2. The compression garment system of claim 1, wherein the one or more pressure applying regions are controllable to apply pressure to one or more portions of the head and neck to move lymph at least from the head towards the neck and downward therefrom.
2. A method of lymphedema treatment of a head and a neck using compression therapy utilizing a head garment including a plurality of head pressure applying regions comprising:
moving lymph from a cheek of the head of a lymphedema patient towards a posterior of the head and from the posterior of the head towards the neck of the lymphedema patient by controlling pressure applied to the head of the body using the plurality of head pressure applying regions of the head garment to reduce localized fluid retention and tissue swelling of the head of the lymphedema patient, at least a portion of the plurality of head pressure applying regions positioned in a pattern radiating away from a face of the head toward the posterior of the head.
Thus, it is apparent, that patent claim 2 includes features that are not in application claim 2, where patent claim 2 includes everything as claimed, see the table above, and where patent claim 2 and application claim 2 differ by reciting the underlined features.
With respect to the features recited in application claim 2 not recited in patent claim 2, patent claim 2 discloses one or more pressure applying regions controllable to apply pressure to the head and neck, see the table above, but is silent with regard to moving lymph from a cheek of a head of a lymphedema patient towards a posterior of the head and from the posterior of the head towards a neck of the lymphedema patient and at least a portion of the plurality of head pressure applying regions positioned in a pattern radiating away from a face of the head toward the posterior of the head.
However, Rosett teaches that the plurality of head pressure applying regions of the head garment (see fig. 1 and lines 70-85 of page 2) includes:
exerting pressure waves on tissues of the user to direct the flow of venous blood and lymphatic fluids away from the cheeks to the neck of the user via a plurality of pressure applying regions along the cheeks and neck of the head, see figs. 1 and 4-5 and see lines 99-122 of page 2 and at least a portion of the plurality of head pressure applying regions positioned in a pattern radiating away from a face of the head toward the posterior of the head (see Rosett transverse tubes 1-6 extend in a pattern from the “center point” of face to the posterior of the head; tubes are of generally semi-circular contour around the head Page 1 lines 60-64).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided patent claim 2’s head garment with a plurality of pressure applying regions along the cheeks and neck of the head in a pattern radiating away from the face of the head toward the posterior of the head, as taught by Rosett, for the purpose of allowing the head garment to focus compression therapy along the cheeks and neck of the head, see figs. 1 and 4 of Rosett.
Additionally, Waldridge teaches that the compression garment (see fig. 1 and the abstract) includes the controller 14 being programmable to individually and sequentially pressurize and depressurize each of the plurality of pressure applying regions 24/26/28/30/32/34/36/38/40/42 (see fig. 1) in the desired sequence, see paras. [0048] and [0067], where pressurization is able to be along or opposite the directions, see fig. 1 and paras. [0049] and [0067], and where the controller 14 is programmed to apply pressure to pressure applying regions 24/26/28/30/32/34/36/38/40/42 to move lymph along the body of the user, see paras. [0048], on a patient specific basis for optimal therapeutic effect, see para. [0067] and [0051], and, therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided patent claim 2’s head garment with a controller, as taught by Waldridge, for the purpose of allowing a user to set a desired sequence and direction of pressurization/depressurization to achieve a desired therapeutic effect, see para. [0048] of Waldridge.
Modified patent claim 2 discloses all the structure as claimed and further discloses a method of compression therapy comprises a step of moving lymph from a cheek of the head of a lymphedema patient towards a posterior of the head and from the posterior of the head towards the neck of the lymphedema patient by controlling pressure applied to the head of the body using the plurality of head pressure applying regions of the head garment (the controller 14 being programmed to sequentially pressurize and depressurize each of a plurality of pressure applying regions, see the table for patent claim 2 above, in a desired sequence and direction, see fig. 1 and paras. [0048]-[0049] and [0067] of Waldridge; such that the controller 14 is able to be programmed to include a sequence of moving lymph from a cheek of a head of a body towards a posterior of the head and a sequence of from the posterior of the head towards a neck of the body).
Since instant application claim 2 is anticipated by patent claim 2, and since anticipation is the epitome of obviousness, then instant application claim 2 is obvious over patent claim 2.
Regarding application claim 3, patent claim 2 reads on the application claim.
Regarding application claim 7, patent claim 2 reads on the application claim.
Regarding application claim 10, patent claim 2 reads on the application claim.
Regarding application claim 13, patent claim 2 reads on the application claim.
Regarding application claim 14, patent claim 2 reads on the application claim.
Regarding application claim 18, patent claim 2 reads on the application claim.
Regarding application claim 19, patent claim 2 reads on the application claim.
Regarding application claim 20, patent claim 2 reads on the application claim.
Regarding application claim 21, patent claim 2 reads on the application claim.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 10 of Wennen (11,311,450).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application claims recite additional features not present in the patent claims.
Regarding application claim 2, the following comparison between the patent claims and the application claim show what elements have been excluded in the presentation of the application claim.
Patent claim 1
Application claim 2
1. A compression garment system comprising:
a head garment portion configured to be donned on a head of a body, wherein the head garment portion comprises one or more head pressure applying regions, and further wherein each of the one or more head pressure applying regions is controllable to apply pressure to a portion of the head,
wherein the head garment portion comprises an under chin garment portion positionable under a chin of the head of the body, wherein the under chin garment portion is configurable to apply pressure to a portion of the head located under the chin,
wherein the head garment portion further comprises a right cheek garment portion positionable proximate a right cheek of the head of the body and a left cheek garment portion positionable proximate a left cheek of the head of the body,
wherein the one or more head pressure applying regions comprise one or more cheek pressure applying regions at the right and left cheek garment portions, and
wherein the head garment portion comprises one or more nasal connection straps adapted to contact a nasal bridge of the head of the body and connecting the right cheek garment portion and the left cheek garment portion to secure the right and left cheek garment portions adjacent the right and left cheeks of the head of the body, respectively,
wherein the plurality of head pressure applying regions include an outer head pressure applying region extending along an edge of the head garment portion,
wherein the edge of the head garment portion is adapted to be positioned from the right cheek of the head to an upper posterior of the head and towards the left cheek of the head; and
a controller configured to control pressure applied by each of the one or more head pressure applying regions to move lymph at least from the head towards a neck of the body, and
wherein the one or more cheek pressure applying regions controllable to apply pressure to a portion of left and right cheeks.
2. A method of lymphedema treatment of a head and a neck using compression therapy utilizing a head garment including a plurality of head pressure applying regions comprising:
moving lymph from a cheek of the head of a lymphedema patient towards a posterior of the head and from the posterior of the head towards the neck of the lymphedema patient by controlling pressure applied to the head of the body using the plurality of head pressure applying regions of the head garment to reduce localized fluid retention and tissue swelling of the head of the lymphedema patient, at least a portion of the plurality of head pressure applying regions positioned in a pattern radiating away from a face of the head toward the posterior of the head.
Thus, it is apparent, for the broadening aspect, that patent claim 1 includes features that are not in application claim 2, where patent claim 1 includes everything as claimed, see the table above, and where patent claim 1 and instant application claim 2 differ by reciting the underlined features.
Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Since instant application claim 2 is anticipated by patent claim 1, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then instant application claim 2 is obvious over patent claim 1 with respect to the broadening aspect.
Regarding application claim 3, patent claim 1 reads on the application claim.
Regarding application claim 4, patent claim 1 reads on the application claim.
Regarding application claim 5, patent claim 2 reads on the application claim.
Regarding application claim 6, patent claim 5 reads on the application claim.
Regarding application claim 7, patent claim 3 reads on the application claim.
Regarding application claim 8, patent claim 4 reads on the application claim.
Regarding application claim 9, patent claim 7 reads on the application claim.
Regarding application claim 10, patent claim 8 reads on the application claim.
Regarding application claim 11, patent claim 10 reads on the application claim.
Regarding application claim 12, patent claim 10 reads on the application claim.
Regarding application claim 13, patent claim 1 reads on the application claim.
Regarding application claim 14, patent claim 1 reads on the application claim.
Regarding application claim 15, patent claim 2 reads on the application claim.
Regarding application claim 16, patent claim 7 reads on the application claim.
Regarding application claim 17, patent claim 10 reads on the application claim.
Regarding application claim 18, patent claim 1 reads on the application claim.
Regarding application claim 19, patent claim 1 reads on the application claim.
Regarding application claim 20, patent claim 1 reads on the application claim.
Regarding application claim 21, patent claim 1 reads on the application claim.
Claims 2-3, 7, 9-14 and 16-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of Wennen (11,166,868).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application claims recite additional features not present in the patent claims.
Regarding application claim 2, the following comparison between the patent claims and the application claim show what elements have been excluded in the presentation of the application claim.
Patent claim 2
Application claim 2
1. A compression garment comprising: a head garment configured to be positioned around both sides of a head of a body from a posterior of the head to an anterior of the head,
wherein the head garment comprises a plurality of controllable head pressure applying regions positionable proximate at least cheeks and a posterior of the head,
each of the plurality of controllable head pressure applying regions comprising one or more cells configured to receive a fluid, wherein the head garment defines an exterior surface and an interior surface opposing the exterior surface,
wherein the interior surface is configured to face the body and the exterior surface is configured to face away from the body and be exposed to an external environment, and
wherein the head garment further comprises at least one weld formed between the exterior and interior surfaces to define the one or more cells,
wherein, during use, one cell of the one or more cells of the head garment extends forward from a posterior portion of the head garment toward a forward portion of the head garment, and further angles downward from the forward portion of the head garment to a cheek portion of the head garment; and
a neck garment coupled to the head garment and configured to be positioned around both sides of a neck of the body from a posterior of the neck to an anterior of the neck, wherein the neck garment comprises at least one controllable neck pressure applying regions.
2. The compression garment of claim 1, wherein the compression garment is controllable by a controller configured to control each of the plurality of head controllable pressure applying regions to apply pressure to the cheeks and the posterior of the head and each of the at least one neck controllable pressure applying regions to apply pressure to a portion of the neck to move lymph at least from the cheeks towards the neck and downwards.
2. A method of lymphedema treatment of a head and a neck using compression therapy utilizing a head garment including a plurality of head pressure applying regions comprising:
moving lymph from a cheek of the head of a lymphedema patient towards a posterior of the head and from the posterior of the head towards the neck of the lymphedema patient by controlling pressure applied to the head of the body using the plurality of head pressure applying regions of the head garment to reduce localized fluid retention and tissue swelling of the head of the lymphedema patient, at least a portion of the plurality of head pressure applying regions positioned in a pattern radiating away from a face of the head toward the posterior of the head.
Thus, it is apparent, for the broadening aspect, that patent claim 2 includes features that are not in application claim 2, where patent claim 2 includes everything as claimed, see the table above, and where patent claim 2 and instant application claim 2 differ by reciting the underlined features.
Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Since instant application claim 2 is anticipated by patent claim 2, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then instant application claim 2 is obvious over patent claim 2 with respect to the broadening aspect.
Regarding application claim 3, patent claim 2 reads on the application claim.
Regarding application claim 7, patent claim 2 reads on the application claim.
Regarding application claim 9, patent claim 2 reads on the application claim.
Regarding application claim 10, patent claim 2 reads on the application claim.
Regarding application claim 11, patent claim 2 reads on the application claim.
Regarding application claim 12, patent claim 2 reads on the application claim.
Regarding application claim 13, patent claim 2 reads on the application claim.
Regarding application claim 14, patent claim 2 reads on the application claim.
Regarding application claim 16, patent claim 2 reads on the application claim.
Regarding application claim 17, patent claim 2 reads on the application claim.
Regarding application claim 18, patent claim 2 reads on the application claim.
Regarding application claim 19, patent claim 2 reads on the application claim.
Regarding application claim 20, patent claim 2 reads on the application claim.
Regarding application claim 21, patent claim 2 reads on the application 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.
Claims 2-3, 7, 9-10, 13-14, 16, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Rosett (1,795,893) in view of Waldridge (2003/0032905).
Regarding claim 2, Rosett discloses a method of lymphedema treatment of a head and a neck using compression therapy utilizing a head garment including a plurality of head pressure applying regions (defined by a hood having head pressure applying regions defined by top section A, cheek section B, and neck section C, see fig. 1; the head garment is pressurized to apply compression to the head of the user, see lines 70-85 of page 2) comprising:
controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions A/B/C of the head garment (the cells 1-6/1-6’ receiving the fluid from a source and the valve mechanism controlling the passage of pressure from the source, see page 2 lines 70-85; the source and the valve mechanism not being shown in the figures of Rosett).
Rosett does not explicitly disclose a step of moving lymph from a cheek of the head of a lymphedema patient towards a posterior of the head and from the posterior of the head towards the neck of the lymphedema patient by controlling the pressure.
However, Waldridge teaches that a compression garment (see fig. 1 and the abstract) includes a controller (defined by pneumatic pump 14, see fig. 1),
the controller 14 being programmable to individually and sequentially pressurize and depressurize each of a plurality of pressure applying regions (defined by compartments 24/26/28/30/32/34/36/38/40/42, see fig. 1) in a desired sequence, see paras. [0048] and [0067], where pressurization is able to be along or opposite a direction, shown by arrows 64, 66 and 68 in fig. 1, see fig. 1 and paras. [0049] and [0067],
where the controller 14 is programmed to apply pressure to pressure applying regions 24/26/28/30/32/34/36/38/40/42 to move lymph along the body of the user, see paras. [0048], on a patient specific basis for optimal therapeutic effect, see para. [0067] of Waldridge and [0051].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided Rosett’s head garment with a controller, as taught by Waldridge, for the purpose of allowing a user to set a desired sequence and direction of pressurization/depressurization to achieve a desired therapeutic effect, see para. [0048] of Waldridge.
The modified Rosett method discloses a step of moving lymph from a cheek of the head of a lymphedema patient towards a posterior of the head and from the posterior of the head towards the neck of the lymphedema patient by controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions of the head garment (where the pressure waves are exerted on tissues of the user to direct the flow of venous blood and lymphatic fluids away from the cheeks to the neck of the user, see fig. 1 and 4-5 and see lines 99-122 of page 2 of Rosett; the controller 14 being programmed to sequentially pressurize and depressurize each of a plurality of pressure applying regions, see figs. 1 and 4-5 of Rosett, in a desired sequence and direction, see fig. 1 and paras. [0048]-[0049] and [0067] of Waldridge; such that the controller 14 is able to be programmed to include a sequence of moving lymph from a cheek of a head of a body towards a posterior of the head and a sequence of from the posterior of the head towards a neck of the body) to reduce localized fluid retention and tissue swelling of the head of the lymphedema patient (see Rosett page 1 lines 5, 8-10 “general object of the invention is… a massaging or kneading action may be imparted to the tissues”; and page 2 lines 99-105 describes by method of inflating and deflating tubes to exert waves of pressure on the tissue undergoing treatment to increase flow of venous blood and lymphatic fluids), at least a portion of the plurality of head pressure applying regions positioned in a pattern radiating away from a face of the head toward the posterior of the head (see Rosett transverse tubes 1-6 extend in a pattern from the “center point” of face to the posterior of the head; tubes are of generally semi-circular contour around the head Page 1 lines 60-64).
Regarding claim 3, the modified Rosett method discloses that controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions of the head garment (see fig. 1 and 4-5 and see lines 99-122 of page 2 of Rosett and see para. [0048] of Waldridge) comprises:
controlling pressure applied to a right cheek and a left cheek of the head of the lymphedema patient using a right cheek garment portion of the head garment proximate a right cheek of the head of the lymphedema patient and a left cheek garment portion of the head garment proximate a left cheek of the head of the lymphedema patient (the plurality of controllable head pressure applying regions A/B/C include a controllable cheek pressure applying region B, shown to be over the left and right cheek of the user, to form a right cheek garment portion and a left cheek garment portion for applying pressure to the right and left cheek of the user, with a top pressure applying region A and neck pressure applying region C being proximate the user’s cheeks, see fig. 4 and page 2 lines 99-122 of Rosett and see para. [0048] of Waldridge).
Regarding claim 7, the modified Rosett method discloses controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions of the head garment (see fig. 4 and page 2 lines 99-122 of Rosett and see para. [0048] of Waldridge) comprises:
controlling pressure applied to a portion of the posterior of the head using a posterior head garment proximate the posterior of the head of the lymphedema patient (the top section A of the head garment is shown to extend around both left and right sides of the posterior of the user’s head, see figs. 1-2 of Rosett, to form a posterior head garment; the posterior head garment being controlled to apply pressure to the posterior of the head of the user, see fig. 4 and page 2 lines 99-122 of Rosett and see para. [0048] of Waldridge).
Regarding claim 9, the modified Rosett method discloses controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions of the head garment (see fig. 4 and page 2 lines 99-122 of Rosett and see para. [0048] of Waldridge) comprises:
controlling pressure applied to a forehead of the head of the lymphedema patient using a forehead garment portion of the head garment positioned proximate the forehead of the head of the lymphedema patient (the plurality of controllable head pressure applying regions A/B/C include a controllable top pressure applying region A, shown to be over the forehead of the user, to form a forehead garment portion for applying pressure to the forehead of the user, see fig. 4 and page 2 lines 99-122 of Rosett and see para. [0048] of Waldridge).
Regarding claim 10, the modified Rosett method discloses that controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions of the head garment (see figs. 1 and 4-5 and see lines 99-122 of page 2 of Rosett and see para. [0048] of Waldridge) further comprises:
providing a fluid to a plurality of cells of the head garment (each of the cells 1-6/1’-6’ is shown to be an elongate tube which is inflated and deflated with a fluid via a valve mechanism and pressurized source, see page 2 lines 70-92 of Rosett).
Regarding claim 13, the modified Rosett method discloses everything as claimed including the head garment and the step of controlling pressure to move lymph, see the rejection of claim 2 above.
The modified Rosett method further discloses a step of controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions of a head garment (the top section A of the head garment is shown to extend around both left and right sides of the posterior of the user’s head, see figs. 1-2 of Rosett, to form a posterior head garment; the posterior head garment being controlled to apply pressure to the posterior of the head of the user, see fig. 4 and page 2 lines 99-122 of Rosett; the user being able to move lymph from the posterior of the head and from the neck of the body, see figs. 1-2 and 4 and page 2 lines 99-122 of Rosett and see para. [0048] of Waldridge)
to move lymph from an anterior of the head of the lymphedema patient towards a posterior of the head and from the posterior of the head towards the neck of the lymphedema patient (the user being able to use the controller 14 to move lymph in a sequence including moving lymph in a direction from the anterior of head toward the posterior of the head and from the posterior of the head towards the neck of the body, see figs. 1-2 and 4 and page 2 lines 99-122 of Rosett and see paras. [0048] and [0067] of Waldridge),
wherein at least two of the plurality of head pressure applying regions extend in different directions relative to one another (see Rosett surrounding the head, as shown in Figs. 4-5, are transverse tubes 1-6 as well as longitudinal tubes 1’-6’. Inflation of tubes 1-6 is carried out by inflation/deflation of tubes 1’-6’ Col. 2 lines 79-85. All of which contact the head and provide some form of treatment).
Regarding claim 14, controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions of the head garment comprises:
controlling pressure applied to a right cheek and a left cheek of the head of the lymphedema patient using a right cheek garment portion of the head garment proximate a right cheek of the head of the lymphedema patient and a left cheek garment portion of the head garment proximate the left cheek of the head of the lymphedema patient to move lymph from the anterior of the head towards the posterior of the head, as recited in the rejection of claim 3 above.
The modified Rosett method further discloses controlling pressure applied to a posterior of the head using a posterior head garment proximate a posterior of the head of the lymphedema patient (the posterior head garment being controlled to apply pressure to the posterior of the head of the user, see fig. 4 and page 2 lines 99-122 of Rosett), to move lymph from the posterior of the head towards the neck of the body (the user being able to use the controller 14 to move lymph in a direction from the posterior of the head to the neck of the body, see figs. 1-2 and 4 and page 2 lines 99-122 of Rosett and see paras. [0048] and [0067] of Waldridge).
Regarding claim 16, the modified Rosett method discloses controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions of the head garment comprises: controlling pressure applied to a forehead of the head of the lymphedema patient using a forehead garment portion of the head garment positioned proximate the forehead of the head of the lymphedema patient, to move lymph from the forehead towards the posterior of the head, as recited in the rejection of claim 9 above.
Regarding claim 18, the modified Rosett method discloses controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions of the head garment (see figs. 1-2 and 4 and page 2 lines 99-122 of Rosett and see paras. [0048] and [0067] of Waldridge) comprises:
controlling pressure applied to a head using the plurality of head pressure applying regions of the head garment to move lymph from one or more lymph nodes located in the head of the lymphedema patient towards one or more axillary nodes of the lymphedema patient (the head garment including the plurality of pressure applying regions, see figs. 1 and 4-5 of Rosett; the user using the controller 14 to move lymph in a programmable sequence and direction, see paras. [0048]-[0049] and [0067] of Waldridge, to move lymph from lymph nodes toward axillary nodes, see para. [0051] of Waldridge).
Regarding claim 19, the modified Rosett method discloses controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions of the head garment (see figs. 1-2 and 4 and page 2 lines 99-122 of Rosett and see paras. [0048] and [0067] of Waldridge) comprises:
controlling pressure applied to the head using the plurality of head pressure applying regions of the head garment to move lymph from a parotid lymph node towards a submandibular lymph node (the plurality of head pressure applying regions including the left and right cheek portions of the head garment, see figs. 1 and 4-5 of Rosett, to apply pressure to the parotid lymph node and the submandibular lymph node; the plurality of head pressure applying regions being controlled to apply pressure in a desired sequence and direction, see paras. [0048] and [0067] of Waldridge, to move lymph from the parotid lymph node and the submandibular lymph node).
Regarding claim 20, the modified Rosett method discloses controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions of the head garment (see figs. 1-2 and 4 and page 2 lines 99-122 of Rosett and see paras. [0048] and [0067] of Waldridge) comprises:
controlling pressure applied to a head using the plurality of head pressure applying regions of the head garment to move lymph from a right retroauricular lymph node towards a right axillary node (the plurality of head pressure applying regions including the left and right cheek portions of the head garment and a neck portion of the head garment, see figs. 1 and 4-5 of Rosett, to apply pressure from the right retroauricular lymph node toward and away from the neck of the user; the plurality of head pressure applying regions being controlled to apply pressure in a desired sequence and direction, see paras. [0048] and [0067] of Waldridge, to move lymph from the right retroauricular lymph node and the right axillary node below the neck of the user).
Regarding claim 21, the modified Rosett method discloses everything as claimed including the plurality of pressure applying regions, the head garment, the step of controlling pressure to move lymph, as recited in the rejection of claim 1 above.
Additionally modified Rosett discloses moving lymph, using the plurality of head pressure applying regions of the head garment, from an anterior lymph node located in an anterior portion of the head of an lymphedema patient towards a more posterior lymph node located in the head (the head garment including the plurality of pressure applying regions along the anterior portion of the head and the posterior portion of the head, see figs. 1 and 4-5 of Rosett, to move lymph from an anterior lymph node and a posterior lymph node; the user using the controller 14 to move lymph in a programmable sequence and direction, see paras. [0048]-[0049] and [0067] of Waldridge, to move lymph from an anterior lymph node and a posterior lymph node, see para. [0051] of Waldridge)
and from the posterior lymph node in the head towards one or more of a submandibular lymph node (the plurality of head pressure applying regions including the pressure apply regions along the posterior of the head and along the left and right cheek portions of the head garment, see figs. 1 and 4-5 of Rosett, to apply pressure to the posterior lymph node and the submandibular lymph node; the plurality of head pressure applying regions being controlled to apply pressure in a desired sequence and direction, see paras. [0048] and [0067] of Waldridge, to move lymph from the posterior lymph node and the submandibular lymph node) to reduce localized fluid retention and tissue swelling of the head of the lymphedema patient (see Rosett page 1 lines 5, 8-10 “general object of the invention is… a massaging or kneading action may be imparted to the tissues”; and page 2 lines 99-105 describes by method of inflating and deflating tubes to exert waves of pressure on the tissue undergoing treatment to increase flow of venous blood and lymphatic fluids), wherein at least one of the plurality of head pressure applying regions follows an arcuate path extending from the anterior portion of the head toward a posterior portion of the head (see Rosett transverse tubes 1-6 extend in a pattern from the “center point” of face to the posterior of the head; tubes are of generally semi-circular contour around the head Page 1 lines 60-64).
Claims 5-6, 8, 11-12, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Rosett and De Besme as applied to claims 2 and 13 above, and further in view of De Besme (3,094,118).
Regarding claim 5, the modified Rosett method discloses the head garment having a portion adjacent to sides of a chin of the lymphedema patient, see figs. 1 and 4 of Rosett, and discloses the step of controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions of the head garment, see fig. 1 and 4-5 and see lines 99-122 of page 2 of Rosett and see para. [0048] of Waldridge.
The modified Rosett method is silent with regard to the step including controlling pressure applied to a portion under a chin of the head of the lymphedema patient using an under chin garment portion of the head garment proximate the chin of the head of the lymphedema patient.
However, De Besme teaches that the head garment (see fig. 1d) is shown to include an under chin garment portion (the head garment is shown to include a portion, having cells C, for applying pressure under the chin of the body, see figs. 1 and 3 and lines 64-70 of col. 1) proximate the chin of the head of the lymphedema patient (the under chin garment portion is shown to be positioned along the underside of the chin, see figs. 1 and 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the modified Rosett head garment with the addition of an under chin garment portion providing controllable pressure to the portion under the chin, as taught by De Besme, for the purpose of allowing the head garment to treat the chin of the lymphedema patient, see lines 64-70 of col. 1 of De Besme.
The modified Rosett method discloses controlling pressure applied to the portion under the chin of the lymphedema patient using the under chin garment portion (the under chin pressure applying region is shown to include the cells C for applying pressure to the underside of the chin of the user, see figs. 1-2 of Rosett and fig. 1 and figs. 1 and 3 and lines 64-70 of col. 1 of De Besme; the cell being controllable to apply pressure under the chin, see page 2 lines 70-85 of Rosett and para. [0048] of Waldridge).
Regarding claim 6, the modified Rosett method discloses connecting a right cheek garment portion of the head garment proximate a right cheek of the head of the lymphedema patient and a left cheek garment portion of the head garment proximate a left cheek of the head of the lymphedema patient (the plurality of controllable head pressure applying regions A/B/C include a controllable cheek pressure applying region B, shown to be over the left and right cheek of the user, to form a right cheek garment portion and a left cheek garment portion for applying pressure to the right and left cheek of the user, see figs. 1 and 4 of Rosett) using one or more under chin straps (defined by tab 16 and a plurality of hooks 17, see figs. 1-3 of Rosett) prior to moving lymph (the under chin connection elements 16/17 being positioned adjacent the under chin garment portion, see figs. 1 and 3 of De Besme, and for connecting the left cheek garment to the right cheek garment, see figs. 1 and 4 and see lines 19-27 of page 2 of Rosett, the head garment being donned and assembled prior to moving lymph to ensure proper pressure is exerted to the lymphedema patient, see lines 12-58 of page 2 of Rosett).
Regarding claim 8, the modified Rosett method discloses that the step of controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions of the head garment (see figs. 1 and 4-5 and see lines 99-122 of page 2 of Rosett and see para. [0048] of Waldridge) comprises:
controlling pressure applied to a right cheek and a left cheek of the head of the lymphedema patient using a right cheek garment portion of the head garment proximate a right cheek of the head of the lymphedema patient and a left cheek garment portion of the head garment proximate a left cheek of the head of the lymphedema patient to move lymph from the right and left cheeks towards the posterior of the head (the plurality of controllable head pressure applying regions A/B/C include a controllable cheek pressure applying region B, shown to be over the left and right cheek of the user, to form a right cheek garment portion and a left cheek garment portion for applying pressure to the right and left cheek of the user, with a top pressure applying region A and neck pressure applying region C being proximate the user’s cheeks, see figs. 4 and page 2 lines 99-122 of Rosett and see para. [0048] of Waldridge; the controlled being programed to move lymph from the right and left cheeks toward the posterior of the head, see figs. 1-2 and 4 and page 2 lines 99-122 of Rosett and see para. [0048] of Waldridge).
The modified Rosett method discloses the head garment having a portion adjacent to sides of a chin of the lymphedema patient, see figs. 1 and 4 of Rosett, and discloses the step of controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions of the head garment, see fig. 1 and 4-5 and see lines 99-122 of page 2 of Rosett and see para. [0048] of Waldridge.
The modified Rosett method is silent with regard to the step including controlling pressure applied to a portion under the chin of the lymphedema patient using an under chin garment portion of the head garment proximate under the chin of the head of lymphedema patient.
However, De Besme teaches that the head garment (see fig. 1d) is shown to include an under chin garment portion (see figs. 1 and 3 and lines 64-70 of col. 1) proximate under a chin of the head of the lymphedema patient (see figs. 1 and 3) and, therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the modified Rosett head garment with the addition of an under chin garment portion providing controllable pressure to the portion under the chin, as taught by De Besme, for the purpose of allowing the head garment to treat the chin of the body, see lines 64-70 of col. 1 of De Besme.
The modified Rosett method discloses controlling pressure applied to the portion under the chin of the lymphedema patient using the under chin garment portion to move lymph from under the chin towards the right and left cheeks (the under chin pressure applying region is shown to include the cells C for applying pressure to the underside of the chin of the user, see figs. 1-2 of Rosett and fig. 1 and figs. 1 and 3 and lines 64-70 of col. 1 of De Besme; the user being able to move lymph toward or away from a portion of the body of the user using the controller 14, see fig. 1 and para. [0049] of Waldridge; the user being able to move lymph from under the chin to toward the right and left cheeks when moving lymph to the posterior of the head, see figs. 1-2 and 4 and page 2 lines 99-122 of Rosett and see paras. [0048]-[0049] of Waldridge).
The modified Rosett method discloses controlling pressure applied to a posterior of the head using a posterior head garment proximate a posterior of the head of the lymphedema patient to move lymph from the posterior of the head towards the neck of the lymphedema patient (the top section A of the head garment is shown to extend around both left and right sides of the posterior of the user’s head, see figs. 1-2 of Rosett, to form a posterior head garment; the posterior head garment being controlled to apply pressure to the posterior of the head of the user, see fig. 4 and page 2 lines 99-122 of Rosett; the user being able to move lymph from the posterior of the head to the left and right cheek garments toward the under chin garment to have lymph move to the neck of the lymphedema patient, see figs. 1-2 and 4 and page 2 lines 99-122 of Rosett and see para. [0048] of Waldridge).
Regarding claim 11, the modified Rosett method discloses the step of controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions of the head garment (see figs. 1-2 and 4 and page 2 lines 99-122 of Rosett and see para. [0048] of Waldridge), but is silent with regard to at least one arcuately shaped head pressure applying region of the plurality of head pressure applying regions.
However, De Besme teaches that the similar head garment (see fig. 1d) includes the controllable cheek and neck pressure applying region (see figs. 1-3 and col. 2 lines 50-57); and
a cell (see annotated fig. 3 of De Besme below), of the cheek and neck pressure applying region 1, extending forward from a posterior portion of the head garment and further angling downward from the forward portion of the head garment to a cheek portion of the head garment to form an arcuately shaped head pressure applying region (the cell is shown to extend from the forward from the posterior portion to the nose of the user and is shown to angle downward from the forward portion of the head garment to the cheek portion of the head garment, see annotated fig. 3 of De Besme).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the shape of the cells of the modified Rosett’s cheek and neck pressure apply regions with shape of the cells of De Besme’s cheek and neck pressure applying regions, for the purpose of providing a more comfortable fit of the cheek and neck pressure applying regions with the user’s face, see col. 1 lines 25-38 and col. 2 lines 22-28 of De Besme, and since it appears that the modified Rosett device would perform equally well when massaging the cheek and neck of the patient.
Annotated fig. 3 of De Besme
PNG
media_image1.png
427
386
media_image1.png
Greyscale
The modified Rosett device discloses controlling pressure applied to the head of the lymphedema patient using at least one arcuately shaped head pressure applying region (the cheek pressure applying regions, as disclosed by Rosett and as taught by De Besme, are shown to have an arcuate shape due to the downward angle, see annotated fig. 3 of De Besme; the controller operated to control pressure applied to the head using the arcuately shaped head pressure applying region, see figs. 1-2 and 4 and page 2 lines 99-122 of Rosett and see para. [0048] of Waldridge).
Regarding claim 12, the modified Rosett method discloses the step of controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions of the head garment (see figs. 1-2 and 4 and page 2 lines 99-122 of Rosett and see para. [0048] of Waldridge), but is silent with regard to at least one head pressure applying region of the plurality of head pressure applying regions of the head garment that extends forward from a posterior portion of the head garment toward a forward portion of the head garment, and further angles downward from the forward portion of the head garment to a cheek portion of the head garment.
However, De Besme teaches that the head garment (see fig. 1d) includes the controllable cheek and neck pressure applying region (see figs. 1-3 and col. 2 lines 50-57); and the cell (see annotated fig. 3 of De Besme), of the cheek and neck pressure applying region 1, extending forward from a posterior portion of the head garment and further angling downward from the forward portion of the head garment to a cheek portion of the head garment (see annotated fig. 3 of De Besme) and, therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the shape of the cells of the modified Rosett’s cheek and neck pressure apply regions with shape of the cells of De Besme’s cheek and neck pressure applying regions, for the purpose of providing a more comfortable fit of the cheek and neck pressure applying regions with the user’s face, see col. 1 lines 25-38 and col. 2 lines 22-28 of De Besme, and since it appears that the modified Rosett device would perform equally well when massaging the cheek and neck of the patient.
Regarding claim 15, the modified Rosett method discloses the step of controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions of the head garment comprises: controlling pressure applied to a chin of the head of the lymphedema patient using an under chin garment portion of the head garment proximate under a chin of the head of the lymphedema patient, as recited in the rejection of claim 5 above.
The modified Rosett method discloses moving lymph from under the chin towards the posterior of the head (the user being able to use the controller 14 to move lymph in a direction from under the chin towards the posterior of the head, see figs. 1-2 and 4 and page 2 lines 99-122 of Rosett and see paras. [0048] and [0067] of Waldridge).
Regarding claim 17, the modified Rosett method discloses the step of controlling pressure applied to the head of the lymphedema patient using the plurality of head pressure applying regions of the head garment comprises: controlling pressure applied to the head of the lymphedema patient using at least one arcuately shaped head pressure applying region of the plurality of head pressure applying regions of the head garment, as recited in the rejection of claim 11 above.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Rosett in view of Waldridge as applied to claim 3 above, and further in view of Klein (US 5,396,881).
Regarding claim 4¸modified Rosett is silent as to connecting the right cheek garment portion and the left cheek garment portion using one or more nasal straps of the head garment configured to be positioned on a nasal bridge of the head of the lymphedema patient prior to moving lymph. However, Klein teaches a nasal strap of the head garment positioned on a nasal bridge of the head of the lymphedema patient (see Klein Fig. 1 and 3 facial portion 2 comprising nasal strip across nasal bridge above nose opening 6; wherein facial portion 2 is formed of two sheets 21, 22 forming an inner volume that as a whole can be pressurized). 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 space between the cheek garment portions of Rosett in view of Waldridge with the addition of a nasal strap positioned on the nasal bridge as taught by Klein so as to ensure the compression garment is securely fit to the user’s head and add therapy benefits to the bridge of the nose.
Response to Arguments
Applicant's arguments filed 01/02/2026 have been fully considered but they are not persuasive.
Applicant argues, on pages 17-18 of the remarks, that the art “fails to teach or suggest at least a portion of the plurality of head pressure applying regions positioned in a pattern radiating away from a face of the head toward the posterior of the head”. However, Examiner disagrees because the tubes of Rosett surround the face of the wearer and then extend from the face towards the posterior of the head from the opening of the face, see rejection to claim 2 above. Therefore, the rejection still stands.
Applicant argues, on pages 18-19 of the remarks, that “Claim 13 requires at least two of the plurality of head pressure applying regions to extend in different directions relative to one another, which Rosett does not teach or suggest”. However, Examiner disagrees because Rosett includes both transverse tubes 1-6 and longitudinal tubes 1’-6’, as evidenced in the rejection to claim 13 above. All of these tubes make up the helmet, and thus is effecting the pressure on the head. Additionally, amended claim 13 is now rejected under 112(b) because it does not appear that the head pressure applying regions (121) of head garment (120) extend in two different directions. Even though the Fig. 7 depiction of regions (121) is extending in an arcuate longitudinal to horizontal shape, the garment (120) when donned would bend and be moveable to attach to the wearer, thus changing the “directionality” of the regions (121), if that is the intended claim language interpretation. Therefore, the rejections till stands.
Applicant argues, on pages 19-20 of the remarks, that the rejection of claim 21 does not teach or suggest “the plurality of head pressure applying regions follows an arcuate path extending from the anterior portion of the head toward a posterior portion of the head”. However, Examiner disagrees as evidenced in the rejection to claim 21 above. Rosett discloses the “semi-circular contour” of the tubes which is an arcuate path. Therefore, the rejection still stands.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GWYNNETH L HOWELL whose telephone number is (703)756-4742. The examiner can normally be reached 8:30-4:30 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tim Stanis can be reached at (571) 272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GWYNNETH L HOWELL/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785