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 .
Information Disclosure Statement
The information disclosure statement filed December 4, 2024 has been received and made of record. Note the acknowledged PTO-1449 enclosed herewith.
Drawings
The drawings are objected to because para. [0045], line 1 recites “FIGS. 2 to 7B and 10A and 13B are all close up views of the present measurement device”; however, FIG. 1A indicates the close up views are directed to FIGS. 2 to 7B and 10A to 12B. Applicant is advised to amend the drawing to recite --FIGS. 2 to 7B and 10A and 13B--.
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.
Specification
The disclosure is objected to because of the following informalities: para. [0053], lines 6, “base layer 22” should recite --base layer 21--; and para. [0059], lines 14, 15 and 19, each “base layer 22” should recite --base layer 21--. Appropriate correction is required.
Claim Objections
The disclosure is objected to because of the following informalities: claim 8, line 6, “stretchable” should read --the stretchable--; and claim 14, “the distance” should read --a distance--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, line 9 recites “a compression level measurement system”, however “a compression level measurement system” was previously recited in line 1. It is unclear to the Office is Applicant is claiming an additional compression level measurement system or the compression level measurement system previously recited. For examination purposes, the Office will interpret the claim as if the recitation in line 9 reads as --the compression level measurement system--.
Regarding claim 4, the recitation, “the at least one indicator on the stretchable base layer” lacks proper antecedent basis. This recitation will be interpreted as --the at least one reference position-- on the stretchable base layer
Regarding claim 5, the recitation “the pre-determined compression levels” lack proper antecedent basis.
Regarding claim 7, the recitation “the material” in lines 1-2 lacks proper antecedent basis.
Regarding claim 8, the claim is indefinite because it is unclear if the compression level measurement system” in lines 6 and 7 is the same as the compression measurement system recited in claim 1 or if Applicant is claiming a different an additional compression measurement system. Further, regarding claim, lines 6-7 recites “an upper layer attached at two spaced apart locations” in line 4, then lines 10-17 recite “an upper layer positioned on top of the stretchable continuous base layer, the upper layer having a width and a length, one fixed end at a first end of the length that is attached to the stretchable continuous base layer at a fixed end attachment location, and one free end opposite the fixed end, the free end having at least one indicator thereon, wherein the length of the upper layer between the fixed end and the free end is adjustable, wherein the free end is attachable to the attachment location on the stretchable continuous base layer”. The claim is indefinite in that it is unclear if Applicant is claiming two upper layers. It appears Applicants are claiming the embodiment of Figs. 11A and 11B which only comprise one upper layer. For the purpose of examination the Office will interpret the claims as follows: 8. An adjustable compression garment having a compression measurement system, comprising: a stretchable continuous base layer comprising a body and one or more bands; and an upper layer attached at two spaced-apart locations to the stretchable continuous base layer and wherein stretchable continuous base layer includes on an upper surface a compression level measurement system, comprising: (a)the stretchable continuous base layer having an attachment location positioned thereon; and (b) the upper layer positioned on top of the stretchable continuous base layer, the upper layer having a width and a length, one fixed end at a first end of the length that is attached to the stretchable continuous base layer at a fixed end attachment location, and a releasable end opposite the fixed end, the releasable end having at least one indicator thereon, wherein the length of the upper layer between the fixed end and the releasable end is adjustable, wherein the releasable end is attachable to the attachment location on the stretchable continuous base layer.
Regarding claim 12, the recitation, “the predetermined compression levels” lacks proper antecedent basis.
Regarding claim 13, the recitation, “the upper layer has at least one indicator” renders the claim indefinite in that it is unclear if Applicant is claiming an additional indicator or the indicator recited in claim 8. If the later, the claim should be amended to recite, --wherein the at least one indicator is aligned with the base layer attachment location to adjust the length of the upper layer between the fixed end and the free end--.
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, 3-6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2005/0192524 (“Lips haw et al.”) in view of U.S. Patent No. 4,213,463 (“Odenkirk”).
Regarding claim 1, Lipshaw et al. discloses a limb encircling therapeutic compression device that substantially discloses Applicants’ presently claimed invention. More specifically, Lipshaw et al. disclose adjustable compression garment (garment 1, see para. [0054] and the embodiment shown in Figs. 1 and Fig.13 and para. [0089]) having a compression measurement system (see para. [0087], which discloses one embodiment of the compression deice provides a garment having a calibrated measuring scare or cared that is used in combination with the bands to measure stretch of the elastic in the bands) comprising: the compression garment adapted to be wrapped around a limb of a patient (see the abstract), the compression garment comprising a body (constituted by central region 10 and lateral margins 7 and 8, see para. [0054] and Fig. 1) adapted to wrap at least partially around the limb of the patient (the central region is wrapped partially around a user’s limb, see para. [0054]), and the body having a plurality of bands (bands 15, see Fig. 1 and col. [0055]) extending therefrom (see Fig.1 ), wherein each band of the plurality of the bands is positioned on the body and having a length such that each of the plurality of bands can attach directly to the body or the plurality of bands when the body and one or more of the plurality of bands is wrapped at least partially around the limb to apply compression by stretching the one or more of the plurality of bands (see para. [0055] and [0056], which disclose each band 15, which has an inner 9 and an outer surface, has a proximal edge 35 and a distal edge 40 and terminates in a distal region 45. The bands 15 are positioned for wrappingly or circumferentially engaging either with the opposite lateral region or with the edges and/or the surfaces of one or more bands extending from the opposite lateral margin and the bands which extend from a lateral region, when wrapped circumferentially around the limb, engage surfaces and/or edges of one or more bands extending from the opposite lateral region), thereby facilitating a compression level measurement system. Further disclosed is that the bands comprise an elastic material (para. [0087]), therefore the bands comprise a stretchable base layer.
Lipshaw et al. fails to disclose at least one of the plurality of bands includes on an upper surface of the at least one of the bands the compression level measurement system, comprising: (a) a stretchable base layer having at least one reference position positioned thereon; and (b) an upper layer positioned on top of the stretchable base layer, the upper layer having a width and a length, one fixed end at a first end of the length that is attached to the stretchable base layer, one free end at a second end of the length that is not attached to the stretchable base layer, and at least one indicator on the upper layer wherein the at least one reference position positioned on the stretchable base layer is disposed such that the at least one indicator of the upper layer moves relative to the at least one reference position on the stretchable layer when the stretchable base layer is stretched.
However, Osenkarski in the disclosure of an alternative tension indicator teaches it is known to provide a device, for which indication of tension is desired, with an upper layer positioned (a) a stretchable base layer (electrode 12) having at least one reference position (envelope 31) positioned thereon; and (b) an upper layer (flap 40) positioned on top of the stretchable base layer (see Figs. 5 and 6), the upper layer having a width and a length (see Fig. 5), one fixed end (fixed end 41, see col. 3, lines 13-14) at a first end of the length that is attached to the stretchable base layer (see Fig. 6), one free end (free or principal portion, col. 3, lines 15-16) at a second end of the length that is not attached to the stretchable base layer (see Figs. 5 and 6 and col. 3), and at least one indicator (45, 46, col. 3, lines 16-18) on the upper layer (see Fig. 5) wherein the at least one reference position positioned on the stretchable base layer is disposed such that the at least one indicator of the upper layer moves relative to the at least one reference position on the stretchable layer when the stretchable base layer is stretched (see Figs. 5-7, col. 3, lines 21-40 and the abstract).
Because both Lipshaw et al. and Osenkarski teach measurement systems for determining the amount tension or stretch in a device, it would have been obvious to one having ordinary skill in the art to have substituted the Osenkarski measurement system for Lipshaw et al.’s measurement by positioning Osenkarski’s measurement system on at least one of the bands in order to readily determine the degree of tension or stretch in band.
Regarding claim 2, modified Lipshaw et al. discloses the compression garment of claim 1, except wherein the upper layer is inelastic. However, it would have been prima facie obvious to one having ordinary skill in the art to have constructed the upper layer of the compression level measurement system from inelastic material in order to prevent the upper layer from stretching independent of the band so as to attain the correct level of compression or tension being placed on the limb by the band.
Regarding claim 3, modified Lipshaw et al. discloses the compression garment of claim 1, wherein the upper layer is opaque (as can be read from para. [0059], the garment may be constructed from neoprene which is opaque).
Regarding claim 4, modified Lipshaw et al. discloses the compression garment of claim 1, wherein one of the at least one indicator on the upper layer aligns with the one of the at least one reference position the stretchable base layer at a pre-determined compression level (once the device of Lipshaw et al. is modified to include the measurement system of Osenkarski, reference position (windows) on the base layer) will align with the indicators on the upper layer, see Figs. 6 and 7 of Osenkarski).
Regarding claim 5, modified discloses the system of claim 4 except wherein the pre-determined compression levels are calibrated for therapeutic effect. However, Lipshaw et al. discloses a measurement system that utilizes the elasticity of the material to measure the amount of applied compression to ensure the garment is applied with gradient compression to the limb (see para. [0085]). Further disclosed is a calibrated measuring scale to measure the stretch of the elastic bands (see page [0087]). As such, it would have been obvious to one having ordinary skill in the art to have used designed the indictors on the upper layer with pre-determined compression levels are that are calibrated for therapeutic effect to ensure the garment is applied with gradient compression to the limb .
Regarding claim 6, modified Lipshaw et al. discloses the compression garment of claim 1, except wherein each of the plurality of bands comprises the compression measurement system. However, it would have been obvious to one having ordinary skill in the art to have placed the measure system of modified Osenkarski on each band in order to readily identify that the same amount of tension is being placed on the limb by each band.
Regarding claim 7, modified Lipshaw et al. discloses the compression garment of claim 1, further comprising fasteners (75, see para. [0063]) separate from the material of each of the plurality of bands and fastened or attached on an underside of each of the plurality of bands (as can be seen from Figs 1 and 3, fasteners 75 are attached on an underside, i.e. the outer surface (3) of each of the bands.
Regarding claim 8, Lipshaw et al. discloses a limb encircling therapeutic compression device that substantially discloses Applicants’ presently claimed invention. More specifically, Lipshaw et al. disclose adjustable compression garment (garment 1, see para. [0054] and the embodiment shown in Figs. 1 and Fig.13 and para. [0089]) having a compression measurement system (see para. [0087], which discloses one embodiment of the compression deice provides a garment having a calibrated measuring scare or cared that is used in combination with the bands to measure stretch of the elastic in the bands). More specifically, Lipshaw et al. discloses a comprising a stretchable continuous base layer (central region 10 and lateral margins 7,8 see para. [0055] constructed from one piece of flexible, foldable hook and loop type fabric being substantially inelastic or form neoprene, see para. [0059]) comprising a body (central region 10 and lateral margins 7,8 see para. [0055]) and one or more bands (bands 15, see Fig. 1 and para. [0055]); and an upper layer attached at two spaced-apart locations to the stretchable continuous base layer and wherein stretchable continuous base layer includes on an upper surface a compression level measurement system, comprising: (a)the stretchable continuous base layer having an attachment location positioned thereon; and (b)an upper layer positioned on top of the stretchable continuous base layer, the upper layer having a width and a length, one fixed end at a first end of the length that is attached to the stretchable continuous base layer at a fixed end attachment location, and one free end opposite the fixed end, the free end having at least one indicator thereon, wherein the length of the upper layer between the fixed end and the free end is adjustable, wherein the free end is attachable to the attachment location on the stretchable continuous base layer.
Allowable Subject Matter
Claim 8 as interpreted appears to contain allowable subject. Specifically, “(a)the stretchable continuous base layer having an attachment location positioned thereon; and (b) the upper layer positioned on top of the stretchable continuous base layer, the upper layer having a width and a length, one fixed end at a first end of the length that is attached to the stretchable continuous base layer at a fixed end attachment location, and a releasable end opposite the fixed end, the releasable end having at least one indicator thereon, wherein the length of the upper layer between the fixed end and the releasable end is adjustable, wherein the releasable end is attachable to the attachment location on the stretchable continuous base layer” is not taught by the prior art.
The closest prior art is that of Osenkarski which discloses a body electrode including a visual indicator to ensure optimal parallel positioning and electrical current distribution between the electrode and the body. The indicator comprises a flap imprinted with alternating areas of green and red indicia, and an exterior sheet overlying the flap and defining three windows. The flap and the exterior sheet are attached at longitudinally spaced locations to a stretchable, insulating cover sheet. Stretching the electrode to a predetermined optimal degree of tension aligns green indicia with the windows, and presence of red indicia in the windows indicates either excessive or insufficient applied tension (see the abstract).
Osenkarski fails to teach, fairly suggest or render obvious a length adjustable flap (40) and a flap (40) having a free attachable to an attachment location.
Claims 9-14 may also contain allowable subject matter by virtue of their dependence on claim 8.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Application Publication No. 2003/0144596 to Tsubata discloses a strap having an elongation indicating means and U.S. Patent Application Publication No. 2007/0205618 to Mueller discloses an elongation indicator for a sling.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIM M LEWIS whose telephone number is (571)272-4796. The examiner can normally be reached Monday -Friday 5:30 am -11:30 am.
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, Alireza Nia can be reached at (571)270-3076. 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.
/KIM M LEWIS/Primary Examiner, Art Unit 3786