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
Applicant’s amendments of claims 1-11 are acknowledged by the Examiner.
Applicant’s amendments of claim 1, 2, and 10 has overcome the previous claim objections. Therefore, the claim objections are withdrawn.
Applicant’s amendment of claims 3 and 7 has overcome some of the previous 112(b) rejections. The 112(b) rejections are updated below.
Applicant’s amendment of claim 5 has rendered the claim interpretation of claim 5 moot.
Claims 1-11 are pending in the current Application.
Response to Arguments
Applicant's arguments with respect to the structure of the absorbent layer have been fully considered but they are not persuasive.
Examiner first notes that the limitations of “front surface” and “back surface” as recited in claim 1 are relative terms and are not defined with respect to any particular structures and thus, within the current interpretation of references the absorbent layer taught by Power can be considered to be on a “front surface” which faces the patient.
With respect to Applicant’s arguments of the term absorbent “pad” compared to “layer” and how the absorbent pad of Power covers a smaller area, Examiner respectfully disagrees because a pad is still a layer as claimed. Additionally the features of the area covered by the absorbent layer, and the ability of the absorbent layer to absorb large amounts of irrigation fluid upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With respect to Applicant’s arguments that the references of Auerbach in view of Power are not at all combinable, Examiner respectfully disagrees. The absorbent layer of Power can easily be included onto the front surface (5) of the drape of Auerbach as suggested by the Examiner.
Applicant’s arguments with respect to the feature of the tourniquet structure have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments with respect to the structure of the perforations have been fully considered but they are not persuasive.
With respect to Applicant’s arguments that the teaching reference of Namenye is completely different from a surgical drape as it is not required to be sterile, Examiner respectfully disagrees. Namenye’s thermal blanket is expressly disclosed in [col 2 ln 30-40] as being sterile packaged such that cleanliness prior to use is guaranteed. Thus, the blanket of Namenye is placed over a user similar to a drape, provides access to a surgical site through the blanket similar to a drape, and is sterile prior to use similar to a drape. As such, the blanket of Namenye is in fact analogous to surgical drapes.
With respect to Applicant’s arguments regarding the disclosure of the teaching reference of Power discussing perforations, Examiner respectfully disagrees. The teaching reference of Power was not relied upon for any teaching of perforations in the previous rejection and thus, these arguments are not relevant to the combination of references as applied in the previous rejection.
In response to applicant's argument based upon the age of the references, contentions that the reference patents are old are not impressive absent a showing that the art tried and failed to solve the same problem notwithstanding its presumed knowledge of the references. See In re Wright, 569 F.2d 1124, 193 USPQ 332 (CCPA 1977).
Claim Objections
Claims 4-7, and 10 are objected to because of the following informalities:
Claim 4 recites the limitation “an arm” in lines 3 and 5. These limitations should be amended to recite “the arm”.
Claim 4 recites the limitation “the drape” in lines 3 and 5. These limitations should be amended to recite “the surgical drape”.
Claim 5 recites the limitation “and indicator” in line 2. This limitation should be amended to recite “an indicator”.
Claim 6 recites the limitation “the means…is glued”. This limitation should be amended to recite “are glued”.
Claim 7 recites the limitation “each of the two folded part” in line 3. This limitation should be amended to recite “each of the two folded parts”.
Claim 10 recites the limitation “area of desired size”. This limitation should be amended to recite “of a desired size”.
Appropriate correction is required.
Claim Interpretation (“means for” limitations)
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.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claims 6 includes the limitation “means for indicating” is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. After consultation of Applicant’s specification [0058], the structure considered to encompass “means for indicating” is a label and equivalents thereof.
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 3-7, and 10-11 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.
Claims 3 and 4 each recites the limitation “the perforations are at a distance”. This limitation is held to be unclear in view of claim 1 which recites “perforations are provided…at a second distance”. Therefore it is unclear as to if “a distance” presented in claim 3 is the same distance as the second distance presented in claim 1, or a different distance. For the purpose of examination, Examiner will interpret the distance of claims 3 and 4 as being the same as the second distance presented in claim 1.
Claim 4 recites the limitation “the open edge” in lines 7 and 8. There is insufficient antecedent basis for the limitations in the claim. For the purpose of examination, Examiner will interpret these limitations as “the open end”.
Claim 4 recite the limitation “preferably” and “most preferred”. The recitation of preferably and most preferred with respect to the distances of the perforations from the open end of the limb sleeve renders the claim unclear as it is unclear if the claimed distances are required by the claim, or merely optional embodiments. For the purpose of examination, Examiner will interpret these “preferable” limitations as being optional.
Claim 5 recites the term “the location” in line 2. There is insufficient antecedent basis for these limitations in the claims. For the purpose of examination, Examiner will interpret these limitations as “ a location”.
Claim 5 recites the limitation “a perforations” in line 2. This limitation renders the claim indefinite because it is unclear if the perforations of claim 5 are the same perforations recited in claim 1, or are new perforations. For the purpose of examination, Examiner will interpret this limitation as being the same perforations.
Claim 6 recites the term “the means for indicating the location” in line 2. There is insufficient antecedent basis for these limitations in the claims. For the purpose of examination, Examiner will interpret these limitations as “ a means for indicating a location”.
Claim 7 recites the limitation "the length direction" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a length direction”.
Claim 7 recites the limitation “the same width” and “the length” in line 4. There is insufficient antecedent basis for these limitations in the claim. For the purpose of examination, Examiner will interpret this limitation as “a same width” and “a length”.
Claim 7 recites the limitation “an open end” in line 6. This limitation renders the claim indefinite because it is unclear if the open end recited in claim 7 is the same open end recited in claim 1, or is a new end of the limb sleeve. For the purpose of examination, Examiner will interpret the open end of claim 7 as being the same open end presented in claim 1.
Claims 7 each recites the limitation “the perforations are at a distance”. This limitation renders the claim indefinite because it is unclear if the distance recited in claim 7 is the second distance recited in claim 1 “perforations are provided…at a second distance”, or is a new. For the purpose of examination, Examiner will interpret the distance of claim 7 as being the same second distance presented in claim 1.
Claim 10 recites the limitation "the surgical drape" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a surgical drape”.
Claim 10 recites the limitation “the surgical drape according to the surgical drape” in line 2. This limitation renders the claim indefinite because it is unclear what is being claimed in the limitation. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 10 recites the limitation "the limb sleeve" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a limb sleeve”.
Claim 10 recites the limitation "the main covering layer" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a main covering layer”.
Claim 10 recites the limitation "the first cut" in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a first cut”.
Claim 10 recites the limitation "the arm" in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an arm”.
Claim 10 recites the limitation "the perforations" in line 8. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a plurality of perforations”.
Claim 10 recites the limitation "the position" in line 11. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a position”.
The term “desired” in claim 10 is a relative term which renders the claim indefinite. The term “desired” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 11 is rejected under 35 U.S.C. 112(b) as being dependent on a rejected claim.
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) 1-4, and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Auerbach et al. (US 2004/0103904 A1) (hereinafter Auerbach) in view of Power et al. (US 2013/0112211 A1) (hereinafter Power), Bainbridge (US 2011/0125112 A1), and Namenye et al. (US 5,443,488) (hereinafter Namenye).
In regards to claim 1, Auerbach discloses a surgical drape (1; see [0027]; see figure 1) for sterile covering of a patient for a shoulder surgery (see [0007] and [0027]), comprising
-a main covering layer (2; see [0027]; see figure 1) having a front surface (5; see [0028]; see figure 3) and a back surface (4; see [0028]; see figure 2),
-wherein a first cut (10; see [0028]; see figure 3; 10 is made via cutting 2 and therefore is considered a cut) is made through the main covering layer (2; see figure 4), the first cut (10) being configured that the surgical drape (1) can move over an arm through the cut (10; see figures 6a-d),
-a limb sleeve (3; see [0027]; see figure 1) having a closed end (32; see [0028]; see figure 1) and an open end (31; see [0028]; see figure 4) wherein the limb sleeve (3) is assembled to the main covering layer (2) at the open end (31) and the first cut (10) aligned such that when the surgical drape (1) is moved over the arm through the first cut (10), the arm is covered by the limb sleeve (3; see figures 6a-d), and
-a tourniquet element (120; see [0048]; see figure 6d) having an opening (120 being a band or strap when formed has an opening) configured to move over the arm and assembled in the limb sleeve (3) at a first distance from the open end (see figure 6d; 120 being a strap or band is capable of moving over the arm and being positioned (i.e. assembled) in the limb sleeve at the distance seen in figure 6d),
an opening (60; see [0048]; see figure 6d) is provided in the limb sleeve (see figure 6d) for removing part of the limb sleeve at a second distance from the open end (see [0048]), and
wherein first distance (distance of 120) is closer to the open end of the limb sleeve with respect to the second distance (distance of 60) such that the tourniquet element (120) is connected to the limb sleeve (3) at a position between the open end (31) of the limb sleeve and the opening (60; see figure 6d).
Auerbach does not disclose an absorbing layer applied to the front surface wherein a first cut is made through the absorbing layer,
the tourniquet element having an elastic opening and a connection edge assembled in the limb sleeve,
wherein the opening is formed by perforations are provided in the limb sleeve for tearing off part of the limb sleeve.
However, Power teaches an analogous drape (100; see [0033]; see figure 1) comprising an analogous main covering layer (110; see [0033]; see figure 1), the main covering layer (110) comprising a front (surface of 110 opposite the surface seen in figure 2) and a back surface (surface of 110 as seen in figure 2); the drape further comprising an absorbing layer (130; see [0038]; see figure 2) applied to the front surface (see figure 2) wherein a first cut (132 and 134; see [0038]; see figure 2) is made through the absorbing layer (130; 132 and 134 being a tear and an aperture are made by cutting and therefore are considered first cuts) and is aligned with a cut (112) of the main covering layer (110; see [0038]) for the purpose of reinforcing the cut of the main covering layer (see [0019]) and collecting any fluids produced during surgery (see [0044]).
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 modified the front surface of the main covering layer as disclosed by Auerbach by including the absorbing layer with a first cut intended to be aligned with the cut of the main covering layer as taught by Power in order to have provided an improved main covering layer that would add the benefit of providing a means for reinforcing the cut of the main covering layer (see [0019]) and collecting any fluids produced during surgery (see [0044]).
Auerbach as now modified by Power still does not disclose the tourniquet element having an elastic opening and a connection edge assembled in the limb sleeve,
wherein the opening is formed by perforations are provided in the limb sleeve for tearing off part of the limb sleeve.
However, Bainbridge teaches an analogous limb sleeve (2; see [0074]; see figure 14a) for use during a medical procedure (see [0001]; decontamination prior to surgery is a medical procedure) further comprising an analogous torniquet element (41; see [0074]; see figure 14a; 42 of 41 is formed of Kraton™ (see [0077]) which is the same material as Applicant’s tourniquet element (see Applicant’s specification [0070]), and is structurally similar to Applicant’s torniquet element (see figure 15 and Applicant’s figure 6); thus, due to the inherent material properties of Kraton™ (see MPEP 2112.01) and structural similarities to Applicant’s torniquet element, 41 is capable of being used as a tourniquet element); the tourniquet element (41) having an elastic opening (48; see [0074]; see figure 15) and a connection edge (52; see [0075]; see figure 14a) assembled in the limb sleeve (2; see figure 14a) for the purpose of ensuring the tourniquet element is located and retained at a desired location within the limb sleeve (See [0075]) and for the purpose of forming the tourniquet element from an elastic material which retains elastic properties when stretched but does not rapidly return to its original shape (see [0077]).
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 modified the tourniquet element as disclosed by Auerbach as now modified by Power and to have included the elastic opening and connection edge of the tourniquet element as taught by Bainbridge in order to have provided an improved tourniquet element that would add the benefit of ensuring the tourniquet element is located and retained at a desired location within the limb sleeve (See [0075]) and the benefit of forming the tourniquet element from an elastic material which retains elastic properties when stretched but does not rapidly return to its original shape (see [0077]).
Auerbach as now modified by Power and Bainbridge still does not disclose wherein the opening is formed by perforations are provided in the limb sleeve for tearing off part of the limb sleeve.
However, Namenye teaches an analogous drape (10; see [Col 4 ln 33-45]; see figure 1) comprising perforations (26, 28, 32, 34, and 38; see [Col 4 ln 60-Col 5 ln 20]; see figure 1) provided in the drape (10) for tearing off part of the drape (10; see figures 3, 5, 7, 9, 10 and 11) for the purpose of providing a variety of shapes and sizes of access openings to be selectively formed through the drape for access to the surgical site (see [abstract]).
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 modified the opening of the limb sleeve intended to be placed over a surgical site as disclosed by Auerbach as now modified by Power and Bainbridge by including the perforations for providing access to the surgical site by tearing off part of the drape as taught by Namenye in order to have provided an improved limb sleeve that would add the benefit of providing a means for creating a variety of shapes and sizes of access openings to be selectively formed through the limb sleeve for access to the surgical site (see [abstract]).
In regards to claim 2, Auerbach as now modified by Power, Bainbridge, and Namenye discloses the invention as discussed above.
Auerbach further discloses wherein the surgical drape (1) further comprises a reinforcement element (40; see [0033]; see figure 1), wherein the reinforcement element (40) has a second cut (45; see [0045]; see figure 4; 45 being a fenestration through 40 is made via cutting 40 and therefore is considered a cut), the second cut (45) being configured that the surgical drape (1) can move over the arm through the second cut (45) and wherein the reinforcement element (40) is applied to the back surface (surface as seen in figure 2) of the main covering layer (2; see figure 2) with the second cut (45) aligned to the first cut (10) such that the surgical drape (1) can move over an arm through the first cut (10) and the second cut (45; see figures 6a-d).
In regards to claim 3, Auerbach as now modified by Power, Bainbridge, and Namenye discloses the invention as discussed above.
Auerbach as now modified by Power, Bainbridge, and Namenye does not explicitly disclose wherein the perforations are at a distance between 5cm and 9cm from the open end of the limb sleevee. However, as can be seen in figure 6d of Auerbach, the removed portion of the limb sleeve (and therefore a location of the included perforations as taught by Namenye) is formed an undisclosed distance from the open edge of the limb sleeve.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the perforations of the limb sleeve of Auerbach as now modified by Power, Bainbridge, and Namenye to be formed at a distance between 5cm and 9cm from the open edge of the limb sleeve since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984) (see MPEP 2144.04 IV A). In the instant case, the limb sleeve of Auerbach as now modified by Power, Bainbridge, and Namenye would not operate differently with the claimed distance between the perforations and the open edge of the limb sleeve and the limb sleeve would function appropriately having the claimed distance. Further, applicant places no criticality on the range claimed, indicating simply that “In some embodiments of the invention, the perforations are at a distance between 5cm and 9cm from the open edge of the limb sleeve” (see [0010]) thereby implying that distances between the perforations and the open edge in other embodiments can be different from those claimed can be used in the limb sleeve.
In regards to claim 4, Auerbach as now modified by Power, Bainbridge, and Namenye discloses the invention as discussed above.
Auerbach further discloses wherein the surgical drape (1) further comprises a reinforcement element (40; see [0033]; see figure 1), wherein the reinforcement element (40) has a second cut (45; see [0045]; see figure 4; 45 being a fenestration through 40 is made via cutting 40 and therefore is considered a cut), the second cut (45) being configured that the drape (1) can move over an arm through the second cut (45) and wherein the reinforcement element (40) is applied to the back surface (surface as seen in figure 2) of the main covering layer (2; see figure 2) with the second cut (45) aligned to the first cut (10) such that the drape (1) can move over an arm through the first cut (10) and the second cut (45; see figures 6a-d).
Auerbach as now modified by Power, Bainbridge, and Namenye does not explicitly disclose wherein the perforations are at a distance between 5cm and 9cm from the open edge of the limb sleeve, preferably between 6cm and 8cm, and most preferred at 7cm from the open edge of the limb sleeve. However, as can be seen in figure 6d of Auerbach, the removed portion of the limb sleeve (and therefore a location of the included perforations as taught by Namenye) is formed an undisclosed distance from the open edge of the limb sleeve.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the perforations of the limb sleeve of Auerbach as now modified by Power, Bainbridge, and Namenye to be formed at a distance between 5cm and 9cm from the open edge of the limb sleeve since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984) (see MPEP 2144.04 IV A). In the instant case, the limb sleeve of Auerbach as now modified by Power, Bainbridge, and Namenye would not operate differently with the claimed distance between the perforations and the open edge of the limb sleeve and the limb sleeve would function appropriately having the claimed distance. Further, applicant places no criticality on the range claimed, indicating simply that “In some embodiments of the invention, the perforations are at a distance between 5cm and 9cm from the open edge of the limb sleeve” (see [0010]) thereby implying that distances between the perforations and the open edge in other embodiments can be different from those claimed can be used in the limb sleeve.
In regards to claim 7, Auerbach as now modified by Power, Bainbridge, and Namenye discloses the invention as discussed above.
Auerbach further discloses wherein the limb sleeve (3) comprises a sleeve starting layer (flexible material; see [0043]) which is folded in the length direction (folded to form free ends; see [0043]), such that a fold is arranged between two folded parts of the limb sleeve starting layer, each of the two folded part having the same width and half of the length of the sleeve stating layer before folding (see [0043] in reference to the method of forming 3, 32 forms the fold as claimed, the upper and lower portions have the same width as can be seen in figure 1, and each have half of the length of the flexible material prior to folding to form 3), and which sleeve starting layer is glued on both sides of the folded parts (free ends; see [0043]; hot melt adhesives are considered to encompass hot gluing) to form the sleeve (3) with a closed end (32) and an open end (31), wherein the folded parts (free ends) are glued up to a third distance (see figure 4 that the free ends of 3 are glued up to 31 as indicated by 36) from the open end (adjacent to 31; see figure 4), and wherein the perforations (perforations as taught by Namenye included onto 3 at a similar location to that of 60 of Auerbach; see Auerbach figure 6d) are at a second distance from the open end (31; see figure 6d) wherein the second distance is larger than or equal to the first distance (see figure 4 that the free ends of 3 are glued all the way to 31, and figure 6d that 60 being spaced from 31 is therefore a greater distance from 31 than the glued free ends).
In regards to claim 8, Auerbach as now modified by Power, Bainbridge, and Namenye discloses the invention as discussed above.
Auerbach further discloses wherein the limb sleeve (3) is glued to the main covering layer (2; see [0044] in reference to adhesives or other supplemental securing techniques being used to secure 38 to 2; see [0045] in reference to glue being used to secure 40 to 2, therefore the adhesives used to secure 38 to 2 are considered to include glue).
In regards to claim 9, Auerbach as now modified by Power, Bainbridge, and Namenye discloses the invention as discussed above.
Auerbach as now modified by Bainbridge further discloses wherein the tourniquet element (120 of Auerbach) is glued in the limb sleeve (3 of Auerbach; see [0047] of Bainbridge in reference to the multiple attachment means of 12 to 10 including gluing; thus as now modified 120 of Auerbach is glued in 3 of Auerbach as taught by Bainbridge).
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Auerbach in view of Power, Bainbridge, and Namenye as applied to claim 1 above, and further in view of Haines et al. (US 2009/01787685 A1) (hereinafter Haines).
In regards to claim 5, Auerbach as now modified by Power, Bainbridge, and Namenye discloses the invention as discussed above.
Auerbach as now modified by Power, Bainbridge, and Namenye does not disclose further comprising and indicator configured for indicating the location of the perforations, wherein the indicator is provided on the limb sleeve.
However, Haines teaches an analogous drape (10; see [0021]; see figure 1) for use over an analogous surgical site (see [abstract]) comprising an analogous section to be torn away (24; see [0026]; see figure 1b) the section to be torn away (24) comprising analogous perforations (36; see [0030]; see figure 1b) configured to be torn to expose the surgical site (see [0030]) further comprising and indicator (30; see [0026]; see figure 1b) configured for indicating the location of the perforations (36), wherein the indicator (30) is provided on the section to be torn away (24) for the purpose of providing a predetermined verification procedure prior to the exposure of the surgical site (See [0026]).
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 modified the area of the limb sleeve to be torn away which comprises perforations as disclosed by Auerbach as now modified by Power, Bainbridge, and Namenye by including the indicator for indicating the location of the perforations as taught by Haines in order to have provided an improved limb sleeve that would add the benefit of providing a predetermined verification procedure prior to the exposure of the surgical site (See [0026]) as well as providing a way of indicating the locations of the perforations and therefore, the surgical site.
In regards to claim 6, Auerbach as now modified by Power, Bainbridge, and Namenye discloses the invention as discussed above.
Auerbach as now modified by Power, Bainbridge, and Namenye does not disclose wherein the means for indicating the location of the perforations is glued on the limb sleeve.
However, Haines teaches an analogous drape (10; see [0021]; see figure 1) for use over an analogous surgical site (see [abstract]) comprising an analogous section to be torn away (24; see [0026]; see figure 1b) the section to be torn away (24) comprising analogous perforations (36; see [0030]; see figure 1b) configured to be torn to expose the surgical site (see [0030]) further comprising a means (30; see [0026]; see figure 1b) for indicating the location of the perforations (36) for the purpose of providing a predetermined verification procedure prior to the exposure of the surgical site (See [0026]).
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 modified the area of the limb sleeve to be torn away which comprises perforations as disclosed by Auerbach as now modified by Power, Bainbridge, and Namenye by including the means for indicating the location of the perforations as taught by Haines in order to have provided an improved limb sleeve that would add the benefit of providing a predetermined verification procedure prior to the exposure of the surgical site (See [0026]) as well as providing a way of indicating the locations of the perforations and therefore, the surgical site.
Auerbach as now modified by Power, Bainbridge, Namenye, and Haines does not explicitly disclose the means for indicating the location of the perforations is glued on the limb sleeve. Haines teaches that the means for indicating the location of the perforations is adhesively attached to the section to be torn away (see [0028]). However, Auerbach teaches the use of glue for adhesively attaching the reinforcement element (40; see [0045]).
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 modified the adhesive attachment method for the means for indicating the location of the perforations as disclosed by Auerbach as now modified by Power, Bainbridge, Namenye, and Haines and to have used glue for adhesively attaching the means for indicating the location of the perforations in order to have provided a strong adhesive bond which would ensure the means for indicating the location of the perforations would not come off of the limb sleeve.
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Auerbach in view of Namenye.
In regards to claim 10, Auerbach discloses A method of sterile covering of a patient for shoulder surgery (see [0006] in reference to the device creating a sterile field for surgery; see [0007] in reference to the device being used on shoulders) using a surgical drape (1; see [0027]; see figure 1) according to the surgical drape (1) is folded such that the limb sleeve (3; see [0027]; see figure 1) can unfold without unfolding the main covering layer (2; see [0027]; see figure 1; see [0046]; see figures 6a-d), comprising
-moving the surgical drape (1) through the first cut (10; see [0028]; see figure 3; 10 is made via cutting 2 and therefore is considered a cut) over an arm of a patient causing that the arm is covered by the limb sleeve (3; see figures 6a-d),
-unfolding the main covering layer (2) over the patient (see [0049] in reference to the panel portion being secured in place after applying the sleeve),
- tearing off part of the limb sleeve (3; see [0048-0049] in reference to the practitioner creating a surgical opening via cutting; this is also considered to include tearing in the instance that a proper cutting tool is not available),
- moving the torn off part of the limb sleeve (3) over the arm away from the shoulder to create an accessible area of desired size for the surgery (see figure 6d that the removed portion of 3 is moved over the arm away from the shoulder).
Auerbach does not disclose tearing off part of the limb sleeve by using perforations, and
- fixing the position of torn off part of the limb sleeve on the arm when the desired size for the accessible area is reached.
However, Namenye teaches an analogous method of using a drape (10; see [Col 4 ln 33-45]; see figure 1) comprising tearing off part of the drape (10; see figures 3, 5, 7, 9, 10 and 11) by using perforations (26, 28, 32, 34, and 38; see [Col 4 ln 60-Col 5 ln 20]; see figure 1) and
- fixing the position of torn off part of the drape on the drape when the desired size for the accessible area is reached (see [col 7 ln 65-col 8 ln 21] in reference to the use of tapes for fixing the flap portions created by tearing the perforations to form a surgical opening of a desired size and shape) for the purpose of providing a variety of shapes and sizes of access openings to be selectively formed through the drape for access to the surgical site (see [abstract]).
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 modified the method of sterile covering of a patient for shoulder surgery, specifically the step of tearing off part of the limb sleeve as disclosed by Auerbach by including perforations for facilitating the tearing off part of the drape, and means for fixing the position of the torn off part of the limb sleeve (and therefore the arm) on the drape when the desired size for the accessible area is reached as taught by Namenye in order to have provided an improved method that would add the benefit of providing a variety of shapes and sizes of access openings to be selectively formed through the limb sleeve for access to the surgical site (see [abstract]).
In regards to claim 11, Auerbach as now modified by Namenye discloses the invention as discussed above.
Auerbach as now modified by Namenye further discloses wherein the fixing of the torn off part of the limb sleeve (3 of Auerbach) is executed by applying a tape on the torn off part of the limb sleeve (see Namenye [Col 7 ln 65-col 8 ln 21] in reference to the use of tapes for fixing the torn off parts of the drape, thus as now combined tape is used to fix the torn off parts of the limb sleeve).
Conclusion
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786
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