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 .
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. The frame shown in figures 1A, 1B, 5 and 8 is not a quadrilateral, but rather an octagon. Therefore, the quadrilateral skirt must be shown or the feature(s) canceled from the claim(s). Also the “tube in communication with the balloon” and “a means for delivering a fluid to the ballon” recited in claim 5 is not shown in the drawings. These features must be shown or cancelled from the claim. 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.
Specification
The disclosure is objected to because of the following informalities: para. [0010], line 7 “Lateral” should recite --lateral--; para. [0010], line 9 “Direct” should read --direct--.
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 1-5 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 1, the recitation of “a balloon with a quadrilateral base skirt” is indefinite since the figures, specifically, Figs 1A and 1B show an eight sided skirt. The examiner is unclear as to what constitutes the quadrilateral base skirt.
Regarding claim 3, the recitation of a “balloon” in line 2 is indefinite in that the Office is unclear if Applicant intends to claim an additional balloon other than the balloon recited in line 2 of claim 1. The recitation of “the inner face of the frame” in line 2 of claim 3 lacks proper antecedent basis since a frame has not been previously recited. Also, “the aperture” in line 4 and “the intermediate region” in lines 4-5 lack proper antecedent basis. For the purpose of compact prosecution, the Office will interpret claim 3 as being dependent from claim 2.
Regarding claim 4, “the frame” in lines 1 and 2 lacks proper antecedent basis.
Regarding claim 5, the recitation of “a means for delivering a fluid to the balloon through the tube” is indefinite in that it is unclear to the Office what structure(s) constitutes this means. For the purpose of compact prosecution, the Office will interpret this means as a pump.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “a means for delivering a fluid to the ballon through the tube” in claim 5. A means for performing this function is not disclosed in the specification.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1 and 6 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claims 1 and 6, the recitation “adhesive pads applied to a patient” claims a portion of the human body along with the invention. The human body and/or parts thereof may not be claimed as components of the invention. Applicant is advised to amend the recitation in claims 1 and 6 to recite --adhesive pads configured to be applied to a patient--.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 2-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2017/0156735 (“Parker”).
Regarding claim 2, Parker discloses an incision compression device that anticipates Applicant’s claimed invention. More specifically, Parker discloses a pressure apparatus (constituted by compression device 110, see Figs. 1-10 and para. [0023]) to reduce post-operative swelling (see the Abstract which discloses the compression device reduces the possibility of post-surgery infirmities including hematoma; hematomas form a pool or lump, i.e., swelling of blood), comprising: a frame (frame 112, see para. [0023]) having an outer periphery (constituted by the outer edge of frame 112, see Figs. 1-10), an inner face (constituted by lower portion 116, see para. [0024]) to be positioned proximate a surgical site on a patient and an outer face (constituted by upper portion 114, see para. [0024]); an aperture (the portion of the frame in which housing 130 is positioned, see Fig. 2) positioned in a central region of the frame between the inner and outer faces (see Fig. 2 and para. [0024] which discloses “[h]ousing 130 may be securely attached to frame 112. For example, as illustrated in FIGS. 1-7, frame 112 includes an upper portion 114 and a lower portion 116 that secures housing 130 in place. Specifically, housing 130 is positioned in between upper portion 114 and lower portion 116); an intermediate region positioned between the aperture and the periphery (the portion of the frame that contains openings 170,172); a plurality of strap-receiving slots (constituted by openings 170,172, see Fig. 2 and para. [0033]) located in the intermediate region (see Fig. 2).
Regarding claim 3, Parker discloses the pressure apparatus of claim 2 (as interpreted), further including: a balloon (constituted by housing 130, which may be a balloon, see para. [0002]) having a skirt (constituted by the rim of the housing; Applicant should note that a skirt is defined by Merriam Webster [https://www.merriam-webster.com/dictionary/skirt] as “the rim, periphery, or environs of an area” or “a part serving as a rim, border, or edging”; therefore the sides of the housing 130 as seen in Fig. 1-7 are a “skirt” as they are the border/periphery of the housing 130) seated adjacent the inner face of the frame (see Fig. 2 which shows the sides of the housing seated adjacent inner face 116), a portion (valve 150, see para. [0031] and Fig. 2) of the housing 130 upon inflation extending outwardly and upwardly away from the patient through the aperture (see Figs. 2-5 which shows valve 150 extending outwardly and upwardly away always, thus also upon inflation of the housing 130, away from the patient, see [0031] extends on the top side of the housing 130 which is opposite the side that contacts the patient as shown in Fig. 11C, and extends through the aperture) the balloon being hermetically sealed in relation to the intermediate region so that upon inflation the balloon may pressed upon an underlying surgical site (housing 130 is completely sealed in that nothing is capable of escaping, therefore it is hermetically sealed, and the housing 130 is locked with the frame 112 and its intermediate region therefore being sealed in relation to the intermediate region).
Regarding claim 4, Parker discloses the pressure apparatus of claim 3 wherein the frame 112 is coextensive with the skirts (see Fig 2, which shows the frame 112 and the sides of housing 130, i.e., skirt, are coextensive as they extend over overlapping spaces) so that the skirt, the frame and the balloon are monolithic (see Fig. 2, which shows the identified skirt, and the housing 130 are monolithic as the skirt is a fully integral substructure of the balloon 130, the balloon 130 and skirt are monolithic with the frame 112 as TheFreeDictionary [https://www.thefreedictionary.com/monolithic] defines monolithic as meaning “acting as a single whole” wherein the balloon 130 and frame 112 are securely combined, see [0024], such that they act as a single whole).
Regarding claim 5, Parker discloses the pressure apparatus of claim 4, further including: a tube (constituted by line 912) in communication with the balloon (see Figs. 9 and 10) and a means (constituted as a syringe 910) for delivering a fluid to the balloon through the tube (see para. [0032] which discloses “[a] syringe 910 may be used to empty or fill housing 130. For instance, as shown in FIGS. 9 and 10, syringe 910 is configured to attach to line 912, line 912 in turn connects to valve 150 of compression device 110”).
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.
Claim(s) 1 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parker in view of U.S. Patent Application No. 2015/0305958 (“Hoff”).
Regarding claim 1, Parker discloses an incision compression device that substantially discloses Applicant’s claimed invention. More specifically, Parker discloses a pressure system (constituted by compression device 110, see (Figures 1-10 and para. [0023]) for managing post-operative swelling (see the Abstract which discloses the compression device reduces the possibility of post-surgery infirmities including hematoma; hematomas form a pool or lump, i.e., swelling of blood), comprising: a balloon (constituted by housing 130, which may be a balloon, see para. [0002]) with a quadrilateral basal skirt (constituted by the frame 112, Applicant should note that a skirt is defined by Merriam Webster [https://www.merriam-webster.com/dictionary/skirt] as “the rim, periphery, or environs of an area” or “a part serving as a rim, border, or edging”; therefore the frame 112, see para. [0023] is a skirt of the housing 130 which provides a rim attached to the housing 130, see Fig. 2, 3 and 4, also the skirt has four sides, thereby being a quadrilateral, and forms a part of the bottom layer of the compression device 110, see layer 116 in Fig. 5 and further provides a base for the balloon 130 to be attached) to be positioned upon a surgical site on a patient (housing 130 and its skirt, i.e., frame, are positioned upon a surgical incision of a patient, see Fig. 11C and [0033-0034]) and an outer face (see Fig. 2, which shows an outer face of housing 130); a plurality of strap-receiving slots (constituted by openings 170 and 172 located in the skirt, constituted by frame 112, see Fig. 2 and para. [0033]); and one or more tensioning straps (constituted by strap 160, see para. [0033]) extending from the strap-receiving slots (see Figs. 11A-11C, 12B and [0033]) so that tension can be applied to the straps and to the skirt in order to press the balloon 130 upon the surgical site (see para. [0033] which discloses “[c]ompression device 110 may include a strap that is attached to frame 112 and secures compression device 110 to a body of the user. For instance, as shown in FIG. 1, frame 112 includes openings 170 and 172 that strap 160 inserts into…as shown in FIGS. 11A-C, strap 160 may have one part that comes across one side of the body and another part of strap 160 may come across a second side of the body to more tightly secure compression device 110 to the body”)
Parker fails to disclose adhesive pads applied to a patient outside the skirt, and the tensioning straps extending between the strap-receiving slots and the adhesive pads.
However, Hoff teaches an analogous compression device (110, see and Fig. 3 and para. [0055]) “comprising an analogous balloon 122 (see Fig. 3 and para. [0055] which discloses a deformable body 122 and para. [0043] which discloses the deformable body may be in the form of a fluid-filled bladder, thereby being a balloon) with a skirt (constituted by support structure 124, see para. [0062] and Figs. 3 and 5, which shows support structure is a periphery of the balloon 122 thereby being a skirt), adhesive pads (130,136 and 140,146, see Fig. 3 and para. [0055-0056]) applied to a patient outside the support structure 124, i.e., skirt (see Fig. 3 which shows adhesive pads 130,136 and 140,146 are outside the skirt 124, and para. [0056] these are applied to a patient), one or more tensioning straps (150 and160) (Fig. 3 and para. [0055]) extending between attachment ends (“first end”/”second end” see para. [0055]) of the balloon (122) and the adhesive pads (130, 136 and 140,146, see Fig. 3 and para. [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure system of Parker to have adhesive pads 130,136 and 140,146), as taught by Hoff and configured to be applied to a patient outside the frame 112, i.e., skirt, and the tensioning straps 160 extending between the strap-receiving slots (openings 170 and 172) wherein these are attachment ends of the frame, i.e., skirt (112) and the adhesive pads 130, 136 and 140,146, as all taught by Hoff, in order to provide the tensioning straps 160 with an increased and more stable securement to the user, thereby further securing the pressure system of Parker in the desired location (see Hoff para.[0056] which discloses “the pressure sensitive adhesive located thereon is used to retain the pressure element 120 on a selected location of a patient before the first and second tension straps 150 and 160 are connected to each other as described herein”).
Regarding claim 1, Parker discloses an incision compression device that substantially discloses Applicant’s claimed invention. More specifically, Parker discloses a pressure system (constituted by compression device 110, see (Figures 1-10 and para. [0023]) for managing post-operative swelling (see the Abstract which discloses the compression device reduces the possibility of post-surgery infirmities including hematoma; hematomas form a pool or lump, i.e., swelling of blood), comprising: a balloon (constituted by housing 130, which may be a balloon, see para. [0002]) with a quadrilateral basal skirt (constituted by the frame 112, Applicant should note that a skirt is defined by Merriam Webster [https://www.merriam-webster.com/dictionary/skirt] as “the rim, periphery, or environs of an area” or “a part serving as a rim, border, or edging”; therefore the frame 112, see para. [0023] is a skirt of the housing 130 which provides a rim attached to the housing 130, see Fig. 2, 3 and 4, also the skirt has four sides, thereby being a quadrilateral, and forms a part of the bottom layer of the compression device 110, see layer 116 in Fig. 5 and further provides a base for the balloon 130 to be attached) to be positioned upon a surgical site on a patient (housing 130 and its skirt, i.e., frame, are positioned upon a surgical incision of a patient, see Fig. 11C and [0033-0034]) and an outer face (see Fig. 2, which shows an outer face of housing 130); a plurality of strap-receiving slots (constituted by openings 170 and 172 located in the skirt, constituted by frame 112, see Fig. 2 and para. [0033]); and one or more tensioning straps (constituted by strap 160, see para. [0033]) extending from the strap-receiving slots (see Figs. 11A-11C, 12B and [0033]) so that tension can be applied to the straps and to the skirt in order to press the balloon 130 upon the surgical site (see para. [0033] which discloses “[c]ompression device 110 may include a strap that is attached to frame 112 and secures compression device 110 to a body of the user. For instance, as shown in FIG. 1, frame 112 includes openings 170 and 172 that strap 160 inserts into…as shown in FIGS. 11A-C, strap 160 may have one part that comes across one side of the body and another part of strap 160 may come across a second side of the body to more tightly secure compression device 110 to the body”)
Parker does not disclose adhesive pads applied to a patient outside the skirt, and the tensioning straps extending between the strap-receiving slots and the adhesive pads.
However, Hoff teaches an analogous compression device (110, see and Fig. 3 and para. [0055]) “comprising an analogous balloon 122 (see Fig. 3 and para. [0055] which discloses a deformable body 122 and para. [0043] which discloses the deformable body may be in the form of a fluid-filled bladder, thereby being a balloon) with a skirt (constituted by support structure 124, see para. [0062] and Figs. 3 and 5, which shows support structure is a periphery of the balloon 122 thereby being a skirt), adhesive pads (130,136 and 140,146, see Fig. 3 and para. [0055-0056]) applied to a patient outside the support structure 124, i.e., skirt (see Fig. 3 which shows adhesive pads 130,136 and 140,146 are outside the skirt 124, and are applied to a patient), one or more tensioning straps (150 and160) (Fig. 3 and para. [0055]) extending between attachment ends (“first end”/”second end” see para. [0055]) of the balloon (122) and the adhesive pads (130, 136 and 140,146, see Fig. 3 and para. [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure system of Parker to have adhesive pads 130,136 and 140,146), as taught by Hoff and configured to be applied to a patient outside the frame 112, i.e., skirt, and the tensioning straps 160 extending between the strap-receiving slots (openings 170 and 172) wherein these are attachment ends of the frame, i.e., skirt (112) and the adhesive pads 130, 136 and 140,146, as all taught by Hoff, in order to provide the tensioning straps 160 with an increased and more stable securement to the user, thereby further securing the pressure system of Parker in the desired location (see para. [0056] of Holt which discloses “the pressure sensitive adhesive located thereon is used to retain the pressure element 120 on a selected location of a patient before the first and second tension straps 150 and 160 are connected to each other as described herein”).
While the combination of Parker and Holt fails to teach adhesive pads applied “around” the surgical site, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure apparatus of Parker and Holt to include additional openings on the top and bottom sides of housing (112) with additional straps having adhesive pads to further ensure that the device is secured to the user on all sides.
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.
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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.
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/KIM M LEWIS/Primary Examiner, Art Unit 3786