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 .
Claim Interpretation (multiple claim sets on file)
In the documents submitted there are multiple sets of submitted claims. The claim set dated 12/13/2024 appears to be submitted by the office in addition to the denial of the refund for multiple dependent claims (10). This claim set is dated 05/03/2024, and therefore, would seem to be the claim set submitted with the first supplementary amendments received 05/03/2024. Examiner notes that an additional supplementary amendment was submitted on 10/24/2024 and addresses the multiple dependency issue. For clarity of the record, Examiner is examining the claim set submitted on 10/24/2024.
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 5 and 6 includes the limitation “means for indicating” and thus are being 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 Objections
Claims 1, 2, and 10 are objected to because of the following informalities:
Claim 1 recites the limitation “the drape” in lines 5, and 7. These limitations should be amended to recite “the surgical drape” to maintain consistency in the claims.
Claim 1 recites the limitation “the cut” in line 5, 6, 8, and 9. These limitations should be amended to recite “the first cut” to maintain consistency in the claims.
Claim 1 recites the limitation “an arm” in line 9. This limitation should be amended to recite “the arm” to avoid a lack of clarity.
Claim 1 recites the limitation “wherein first distance” in line 14. This limitation should be amended to recite “wherein the first distance”.
Claim 1 recites the limitation “wherein first distance is lower than the second distance”. This recitation is borderline unclear as to what is being claimed given that “lower” is a relative term, dependent on orientation and which angle the device is being viewed from. For the purpose of examination, Examiner will interpret this limitation as “wherein the first distance is closer to the open end of the limb sleeve with respect to the second distance” and recommends Applicant amend the claim similarly.
Claim 2 recites the limitation “the drape” in lines 3 and 5. These limitations should be amended to recite “the surgical drape” to maintain consistency in the claims.
Claim 2 recites the limitation “an arm” in lines 3 and 5. This limitation should be amended to recite “the arm” to avoid a lack of clarity.
Claim 10 recites the limitation “causing that the arm”. This limitation should be amended to recite “such that the arm”.
Claim 10 recites the limitation “tearing off part” in line 7. This limitation should be amended to recite “tearing off a part” to properly present a part of the limb sleeve.
Claim 10 recites the limitation “the surgery” in line 9. This limitation should be amended to recite “the shoulder surgery” to maintain consistency in the claims.
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 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 claim 3 as being the same as the second distance presented in claim 1.
Claims 3 and 4 each recites 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.
Claims 3 and 4 recite the limitation “the open edge”. There is insufficient antecedent basis for these limitations in the claims. For the purpose of examination, Examiner will interpret these limitations as “the open end”.
Claim 5 and 6 recite 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 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 best understood.
Claim 7 recites the limitation "the folded parts" 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 best understood.
Claim 7 recites the limitation “glued on both sides of the folded parts”. However, it is unclear as to which sides of the starting layer are being glued. For the purpose of examination, examiner will interpret this limitation as best understood.
Claim 7 recites the limitation “glued up to a first distance”. The recitation of “a first distance renders claim 7 unclear as a first distance was presented in claim 1 from which claim 7 depends. Therefore, it is unclear as to if “a first distance” in claim 7 is the same as the first distance presented in claim 1, or a different distance. For the purpose of examination, Examiner will interpret the first distance of claim 7 as being a different distance from the first distance presented in claim 1, and will interpret claim 7 as best understood.
Claims 7 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 claim 3 as being the same as the second distance presented in claim 1.
Claim 7 recites the limitation “a closed end and an open end”. These limitations are considered unclear given claim 1 recites the limitations of a closed end and an open end. Therefore it is unclear as to if the closed and open ends of claim 7 are new ends of the sleeve or the same as presented in claim 1. For the purpose of examination, Examiner will interpret the ends of claim 7 as being the same as the ends presented in claim 1.
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 4. 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 shoulder" 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 shoulder”.
Claim 10 recites the limitation "the position" in line 10. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a position”.
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, Fancher (US 2004/0199974 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 cut (10) being configured that the 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 cut (10) aligned such that when the drape (1) is moved over the arm through the 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 an arm and a connection edge (38; see [0044]; see figure 4) assembled in the limb sleeve (3) at a first distance from the open end (see figure 6d; 120 being a strap is configured to move as claimed),
removing part of the limb sleeve (3) at a second distance from the open end (31; see [0048] in reference to 60; see figure 6d), and
wherein first distance (distance of 120) is lower than 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 removed part (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
wherein perforations are provided in the limb sleeve for tearing off part of the limb sleeve at a second distance from the open end, and, and
the tourniquet element is connected in 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
wherein perforations are provided in the limb sleeve for tearing off part of the limb sleeve at a second distance from the open end, and, and
the tourniquet element is connected in the limb sleeve.
However, Fancher teaches an analogous limb sleeve (10; see [0025]; see figure 1) comprising an analogous band (12; see [0025]; see figure 1; 12 is considered analogous to the tourniquet of Auerbach given that the tourniquet of Auerbach is described in [0048] as being a band) the band (12) having an elastic opening (see [0015] in reference to the band being elastic and therefore having an elastic opening), and
the band (12) is connected in the limb sleeve (10; see [0047] in reference to the multiple attachment means of 12 to 10 including gluing; see figure 5 that 12 is connected in a folded region of 10) for the purpose of preventing exposure to damaging moisture, fluids or other contaminants to the area of concern (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 tourniquet element as disclosed by Auerbach as now modified by Power and to have formed the tourniquet element as an elastic band (with an elastic opening) connected in the limb sleeve in the fashion including gluing as taught by Fancher in order to have provided an improved tourniquet element that would add the benefit of preventing exposure to damaging moisture, fluids or other contaminants to the area of concern (see [abstract]) as well as increasing the ease of use as the tourniquet element would unitarily be formed with the limb sleeve, removing the need for separate application of the tourniquet before surgery.
Auerbach as now modified by Power and Fancher still does not disclose wherein perforations are provided in the limb sleeve for tearing off part of the limb sleeve at a second distance from the open end, and, and
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 limb sleeve intended to be placed over a surgical site as disclosed by Auerbach as now modified by Power and Fancher by including the perforations for providing access to the surgical site 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, Fancher, 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).
In regards to claim 3, Auerbach as now modified by Power, Fancher, and Namenye discloses the invention as discussed above.
Auerbach as now modified by Power, Fancher, 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, Fancher, 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, Fancher, 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, Fancher, 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, Fancher, 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, Fancher, 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, Fancher, 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, Fancher, 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]) and 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 first 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, Fancher, 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, Fancher, and Namenye discloses the invention as discussed above.
Auerbach as now modified by Fancher further discloses wherein the tourniquet element (120 of Auerbach) is glued in the limb sleeve (3 of Auerbach; see [0047] of Fancher 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 Fancher).
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Auerbach in view of Power, Fancher, 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, Fancher, and Namenye discloses the invention as discussed above.
Auerbach as now modified by Power, Fancher, and Namenye does not disclose further comprising a means for indicating the location of the perforations, wherein the means for indicating the location of the perforations 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 a means (30; see [0026]; see figure 1b) for indicating the location of the perforations (36), wherein the means (30) for indicating the location of the perforations (36) 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, Fancher, 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.
In regards to claim 6, Auerbach as now modified by Power, Fancher, and Namenye discloses the invention as discussed above.
Auerbach as now modified by Power, Fancher, and Namenye does not disclose further comprising a means for indicating the location of the perforations, 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, Fancher, 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, Fancher, 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, Fancher, 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) wherein 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/Examiner, Art Unit 3786