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 .
Specification
The use of the term Kraton™, which is a trade name or a mark used in commerce, has been noted in this application in paragraph [0070]. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
The use of the term Velcro™, which is a trade name or a mark used in commerce, has been noted in this application in paragraph [0076]. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Double Patenting
Claims 1-4, and 14-16 of this application is patentably indistinct from claim 1-2 and 10-11 of Application No. 18/439,586. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, and 15-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2 and 10-11 of copending Application No. 18/439,586 (reference application; With regards to claim 10 of the reference application, the Examiner cites claim 10 from the claim set submitted on 10/24/2024 because the claim amendments of claim 10 submitted 11/17/2025 are non-compliant). Although the claims at issue are not identical, they are not patentably distinct from each other because
Instant Application
Reference Application
l. A surgical drape for sterile covering of a patient for a shoulder surgery, comprising:
a main covering layer having a front surface and a back surface;
an absorbing layer applied to the front surface wherein a first cut is made through the absorbing layer and the main covering layer, the cut being configured that the drape can move over an arm through the cut;
a limb sleeve having a closed end and an open end wherein the limb sleeve is assembled to the main covering layer at the open end and the cut aligned such that when the drape is moved over the arm through the cut, the arm is covered by the limb sleeve; and
a tourniquet element having an elastic opening configured to move over an arm and a connection edge assembled in the limb sleeve at a first distance from the open end.
1. A surgical drape for sterile covering of a patient for a shoulder surgery, comprising
- a main covering layer having a front surface and a back surface,
- an absorbing layer applied to the front surface wherein a first cut is made through the absorbing layer and the main covering layer, the cut being configured that the drape can move over an arm through the cut,
- a limb sleeve having a closed end and an open end wherein the limb sleeve is assembled to the main covering layer at the open end and the cut aligned such that when the drape is moved over the arm through the cut, the arm is covered by the limb sleeve, and
- a tourniquet element having an elastic opening configured to move over an arm and a connection edge assembled in the limb sleeve at a first distance from the open end….
2. The surgical drape of claim 1, wherein perforations are provided in the limb sleeve for tearing off part of the limb sleeve at a second distance from the open end.
1. …wherein perforations are provided in the limb sleeve for tearing off part of the limb sleeve at a second distance from the open end…
3. The surgical drape of claim 2, wherein first distance is lower than the second distance such that the tourniquet element is connected in the limb sleeve at a position between the open end of the limb sleeve and the perforations.
1. wherein first distance is closer to (i.e. “lower than” as per Applicant’s specification) the open end of the limb sleeve with respect to the second distance such that the tourniquet element is connected in the limb sleeve at a position between the open end of the limb sleeve and the perforations
4. The surgical drape of claim 3, wherein the surgical drape further comprises a reinforcement element, wherein the reinforcement element has a second cut, the second cut being configured that the drape can move over an arm through the second cut and wherein the reinforcement element is applied to the back surface of the main covering layer with the second cut aligned to the first cut such that the drape can move over an arm through the first cut and the second cut.
2. The surgical drape according to claim 1, wherein the surgical drape further comprises a reinforcement element, wherein the reinforcement element has a second cut, the second cut being configured that the drape can move over an arm through the second cut and wherein the reinforcement element is applied to the back surface of the main covering layer with the second cut aligned to the first cut such that the drape can move over an arm through the first cut and the second cut.
14. A method of sterile covering of a patient for shoulder surgery using a surgical drape, comprising:
moving the surgical drape through the first cut over an arm of a patient causing that the arm is covered by the limb sleeve;
unfolding the main covering layer over the patient;
tearing off part of the limb sleeve at the perforations;
moving the torn off part of the limb sleeve over the arm away from the shoulder to create an accessible area of desired size for the surgery; 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.
10. A method of sterile covering of a patient for shoulder surgery using a surgical drape…, comprising
- moving the surgical drape through the first cut over an arm of a patient causing that the arm is covered by the limb sleeve,
- unfolding the main covering layer over the patient,
- tearing off part of the limb sleeve at the perforations,
- moving the torn off part of the limb sleeve over the arm away from the shoulder to create an accessible area of desired size for the surgery,
- fixing the position of torn off part of the limb sleeve on the arm when the desired size for the accessible area is reached.
15. The method of claim 14, wherein the surgical drape is folded such that the limb sleeve can unfold without unfolding the main covering layer.
10. …wherein the surgical drape is folded such that the limb sleeve can unfold without unfolding the main covering layer…
16. The method of claim 14, wherein the fixing of the torn off part of the limb sleeve is executed by applying a tape on the torn off part of the limb sleeve.
11. The method of claim 10, wherein the fixing of the torn off part of the limb sleeve is executed by applying a tape on the torn off part of the limb sleeve.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
While claims 7, and 9-13 of the instant application are recited in claims 3, and 5-9 of the reference Application, claims 7, and 9-13 of the instant application depend from claims 5-6 that contain limitations which are not recited in the reference application.
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 do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Attachment element in claim 6. “Attachment element” is considered to encompass a double-sided tape, a hook- and-loop connection such as Velcro, or any other material known in the art which is suitable for attaching surgical drape materials to each other after consultation of Applicant’s specification [0076].
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 9 and 10 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 [0069], the structure considered to encompass “means for indicating” is a label and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1-4, 8, 14, and 16 are objected to because of the following informalities:
Claim 1 recites the limitation “a surgical drape for sterile covering of a patient for a shoulder surgery”. This limitation should be amended to include “configured for” language.
Claim 1 recites the limitation “the drape” in lines 4, and 8. These limitations should be amended to recite “the surgical drape” to maintain consistency in the claims.
Claim 1 recites the limitation “the cut” in lines 4, 5, 7, and 8. 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 10. This limitation should be amended to recite “the arm” to avoid a lack of clarity.
Claim 2 recites the limitation “tearing off part” in line 2. This limitation should be amended to recite “tearing off a part” to properly present a part of the limb sleeve.
Claim 3 recites the limitation “wherein first distance” in line 1. This limitation should be amended to recite “wherein the first distance”.
Claim 3 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 4 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 4 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 8 recites the limitation “provided circumferential around the limb sleeve”. This limitation should be amended to recite “circumferentially”.
Claim 14 recites the limitation “a patient” in line 3. While not unclear, this limitation should be amended to recite “the patient” as a patient is presented in the preamble of the claim.
Claim 14 recites the limitation “causing that the arm”. This limitation should be amended to recite “such that the arm”.
Claim 14 recites the limitation “tearing off part” in line 6. This limitation should be amended to recite “tearing off a part” to properly present a part of the limb sleeve.
Claim 14 recites the limitation “moving the torn off part”. While not unclear, this limitation should be amended to recite “moving the part” to maintain consistency in the claims.
Claim 14 recites the limitation “the surgery” in line 9. This limitation should be amended to recite “the shoulder surgery” to maintain consistency in the claims.
Claim 14 recites the limitation “fixing the position of the torn off part”. While not unclear, this limitation should be amended to recite “fixing the position of the part” to maintain consistency in the claims.
Claim 16 recites the limitation “wherein fixing the torn off part…applying a tape on the torn off part”. While not unclear, this limitation should be amended to recite “wherein fixing the position of the part…applying a tape on the part” 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 6-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation “attaching a part of the limb sleeve, in particular a part of the limb sleeve between the open end of the limb sleeve and the perforations”. The recitation of “in particular” renders the claim indefinite as to if the part being between the open end of the limb sleeve and the perforations are required, or merely a preferred embodiment. For the purpose of examination, Examiner will interpret the claim as “attaching a part of the limb sleeve between the open end of the limb sleeve and the perforations”.
Claim 7 recites the limitation “the perforations are at a distance”. This limitation is held to be unclear in view of claim 2 which recites “perforations are provided…at a second distance”. Therefore it is unclear as to if “a distance” presented in claim 7 is the same distance as the second distance presented in claim 2, or a different distance. For the purpose of examination, Examiner will interpret the distance of claim 7 as being the same as the second distance presented in claim 2.
Claim 7 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.
Claim 7 recites 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 9 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 11 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 11 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 11 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 11 recites the limitation “glued up to a first distance”. The recitation of “a first distance renders claim 11 unclear as a first distance was presented in claim 1 from which claim 11 depends. Therefore, it is unclear as to if “a first distance” in claim 11 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 11 as being a different distance from the first distance presented in claim 1, and will interpret claim 11 as best understood.
Claims 11 recites the limitation “the perforations are at a second distance”. This limitation is held to be unclear in view of claim 2 which recites “perforations are provided…at a second distance”. Therefore it is unclear as to if “a second distance” presented in claim 11 is the same distance as the second distance presented in claim 2, or a different distance. For the purpose of examination, Examiner will interpret the second distance of claim 11 as being the same as the second distance presented in claim 2.
Claim 11 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 11 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 11 as being the same as the ends presented in claim 1.
Claim 14 recites the limitation "the first cut" 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 first cut”
Claim 14 recites the limitation “moving the surgical drape through the first cut over an arm”. This limitation is unclear if Applicant is moving the drape through the first cut, or moving the arm of the patient through the first cut. For the purpose of examination, Examiner will interpret this limitation as “moving an arm of a patient through the first cut of the surgical drape”
Claim 14 recites the limitation "the limb sleeve" 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 limb sleeve”
Claim 14 recites the limitation "the main covering layer" 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 main covering layer”.
Claim 14 recites the limitation "the shoulder" in line 7. 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 14 recites the limitation "the position" in line 9. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a position”.
Claims 8, 10, 12-13, and 15-16 are 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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goodman (US 4,119,093 A) in view of Gustafsson et al. (US 2010/0024831 A1) (hereinafter Gustafsson) and Andrisevic et al. (US 2024/0350301 A1) (hereinafter Andrisevic).
In regards to claim 1, Goodman discloses A surgical drape (30; see [col 3 ln 67-68]; see figure 1) for sterile covering of a patient for a shoulder surgery (see figure 10), comprising:
a main covering layer (34; see [col 4 ln 5]; see figure 1) having a front surface (64; see [col 5 ln 44]; see figure 2) and a back surface (62; see [col 5 ln 45]; see figure 2);
wherein a first cut (36; see [col 4 ln 8-9]; see figure 1 and 3; 36 is made via cutting 34 to form 36 and thus, is a first cut) is made through the main covering layer (34; see figure 3), the cut (36) being configured that the drape (30) can move over an arm through the cut (36; see [col 5 ln 50-68]; see figure 8);
a limb sleeve (38; [col 4 ln 9-10]; see figure 2) having a closed end (42; see [col 4 ln 10-15]; see figure 3) and an open end (40; see [col 4 ln 10-15]; see figure 3) wherein the limb sleeve (38) is assembled to the main covering layer (38) at the open end (40) and the cut (36) aligned such that when the drape (30) is moved over the arm through the cut (36), the arm is covered by the limb sleeve (38; see figure 8);and
a tourniquet element (88; see [col 7 ln 17-18]; see figure 24) having an opening configured to move over an arm (see figure 24).
Goodman does not disclose an absorbing layer applied to the front surface the first cut through the absorbing layer; and
the opening of the tourniquet is an elastic opening, and a connection edge assembled in the limb sleeve at a first distance from the open end.
However, Gustafsson teaches an analogous surgical drape (1; see [0016]; see figure 1) comprising a main covering layer (3; see [0016]; see figure 1) having a front surface (external surface; see figure 1), a back surface (internal surface facing patient; see figure 1), and a first cut (O; see [0016]; see figure 1; O being an opening formed in a non-woven material is to be cut from said material and thus, is a first cut); further comprising an absorbing layer (2; see [0016]; see figure 1) applied to the front surface (external surface) the first cut (O) is made through the absorbing layer (2; see figure 1) for the purpose of absorbing blood and other fluids emanating from the surgical site (see [0005]).
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 main covering layer as disclosed by Goodman and to have included the absorbing layer applied to the front surface of the main covering layer as taught by Gustafsson in order to have provided an improved surgical drape that would add the benefit of providing a means for absorbing blood and other fluids emanating from the surgical site (see [0005]).
Goodman as now modified by Gustafsson still does not disclose the opening of the tourniquet is an elastic opening, and a connection edge assembled in the limb sleeve at a first distance from the open end.
However, Andrisevic teaches an analogous limb sleeve (102; see [0018]; see figure 1a) to be used during a medical procedure (see [0017]; the limb sleeve (102) comprising an open end (110; see [0019]; see figure 1a) and closed end (112; see [0019]; see figure 1a), and further comprising an analogous tourniquet (108; see [0019]; see figure 1b) with an analogous opening (opening which receives a user’s arm; see figure 1a); the opening (opening of 108) of the tourniquet (108) is an elastic opening (108 is formed from an elastic material, thus the opening of 108 is elastic; see [0031]), and a connection edge (edges of 108 which connect to 134-1/2; see figure 1b) assembled in the limb sleeve (102; see figure 1b) at a first distance from the open end (110; see figure 1b that 108 and associated connection edges are formed near 110).
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 as disclosed by Goodman as now modified by Gustafsson and to have substituted the inflatable tourniquet of Goodman for the elastic tourniquet which forms an elastic opening and connection edges assembled in the limb sleeve as taught by Andrisevic in order to have provided an improved limb sleeve that would add the benefit of providing an integrated elastic tourniquet which can be elastically adjusted to accommodate different sized users, and provide an elastic compression tourniquet effect.
Furthermore, such a modification is held to be obvious since it has been held that “(w)here a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d 1509 (BPAI, 2007) (citing KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1396 (2007) (see MPEP 2143 I B). Accordingly, Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results. In the instant case substitution of the inflatable tourniquet for the elastic tourniquet is no more than a simple substitution of one known tourniquet for another which would add the benefits of the elastic tourniquet of Andrisevic as discussed above.
Claim(s) 2-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goodman in view of Gustafson and Andrisevic as applied to claim 1 above, and further in view of Namenye et al. (US 5,443,488 A) (hereinafter Namenye).
In regards to claim 2, Goodman as now modified by Gustafsson, and Andrisevic discloses the invention as discussed above.
Goodman further discloses the limb sleeve is intended to be cut to provide access to the surgical site (see [col 6 ln 29-35]). Goodman as now modified by Gustafsson, and Andrisevic 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.
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 as disclosed by Goodman as now modified by Gustafsson, and Andrisevic 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 3, Goodman as now modified by Gustafsson, Andrisevic, and Namenye discloses the invention as discussed above.
Goodman as now modified by Andrisevic, and Namenye further discloses wherein first distance (distance adjacent the open end to which 108 of Andrisevic is included into 38 of Goodman) is lower than the second distance (distance between the open end and the surgical site) such that the tourniquet element (108 of Andrisevic) is connected in the limb sleeve (38 of Goodman) at a position between the open end of the limb sleeve (40 of 38 of Goodman) and the perforations (26, 28, 32, 34, and 38 of Namenye provided over the surgical site; see Andrisevic figure 1b that 108 is positioned closer to the open end than opening 126 through which the procedure of Andrisevic is conducted through; therefore the tourniquet element of Andrisevic when substituted into the limb sleeve of Goodman would be positioned similarly closer to the open end than surgical site).
In regards to claim 4, Goodman as now modified by Gustafsson, Andrisevic, and Namenye discloses the invention as discussed above.
Goodman further discloses wherein the surgical drape (30) further comprises a reinforcement element (48; see [col 4 ln 15-20]; see figure 16), wherein the reinforcement element (48) has a second cut (see figure 16), the second cut being configured that the drape (30) can move over an arm through the second cut (see figure 16) and wherein the reinforcement element (48) is applied to the back surface (62) of the main covering layer (34) with the second cut aligned to the first cut such that the drape (30) can move over an arm through the first cut and the second cut (see figure 16 that the patient’s limb moves through both 34 and 48 and thus moves through the cuts in 34 and 48).
In regards to claim 5, Goodman as now modified by Gustafsson, Andrisevic, and Namenye discloses the invention as discussed above.
Goodman further discloses wherein the limb sleeve (38) has a larger width at the open end (40) than at the closed end (42; see [col 4 ln 53-col 5 ln 15] in reference to the differing diameters of 38; see figure 3).
In regards to claim 6, Goodman as now modified by Gustafsson, Andrisevic, and Namenye discloses the invention as discussed above.
Goodman as now modified by Gustafsson further discloses wherein the absorbing layer (2 of Gustafsson) adjacent to the first cut (36 of Goodman) further comprises an attachment element (holt melt adhesive of Gustafsson; see Gustafsson [0035]) which is configured for attaching a part of the limb sleeve (38 of Goodman), in particular a part of the limb sleeve between the open end of the limb sleeve and the perforations, to the absorbing layer (2 of Gustafsson; the hot melt adhesive of 2 of Gustafsson, when included onto the drape of Goodman, is configured for (i.e. capable of) attaching to the 38 of Goodman in the position as claimed).
In regards to claim 7, Goodman as now modified by Gustafsson, Andrisevic, and Namenye discloses the invention as discussed above.
Goodman as now modified by Gustafsson, Andrisevic, 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, Goodman discloses the limb sleeve is intended to be cut to provide access to the surgical site (see [col 6 ln 29-35]). Thus, the perforations of Namenye, when included onto the limb sleeve of Goodman to allow a surgeon to easily tear the limb sleeve to access the surgical site, are formed at an undisclosed distance from the open end of the limb sleeve over the surgical site.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to position the perforations of the limb sleeve of Goodman as now modified by Gustafsson, Andrisevic, and Namenye 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 Goodman as now modified by Gustafsson, Andrisevic, 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 when 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 [0013]) thereby implying that distances between the perforations in the limb sleeve, and the open end of the limb sleeve in other embodiments can be different from those claimed, and said distance is a design choice obvious to one of ordinary skill in the art.
In regards to claim 8, Goodman as now modified by Gustafsson, Andrisevic, and Namenye discloses the invention as discussed above.
Goodman as now modified by Namenye further discloses wherein the perforations (26, 28, 32, 34, and 38 of Namenye) are provided circumferential around the limb sleeve (38 of Goodman; see Namenye figure 1 that the perforations extend along a width and length of the drape; thus, when the perforations of Namenye are included into the conical limb sleeve of Goodman, the perforations extending in the width direction of Namenye are provided about the circumference of the limb sleeve).
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goodman in view of Gustafson, Andrisevic, and Namenye as applied to claim 8 above, and further in view of Haines et al. (US 2009/0178685 A1) (hereinafter Haines).
In regards to claim 9, Goodman as now modified by Gustafsson, Andrisevic, and Namenye discloses the invention as discussed above.
Goodman as now modified by Gustafsson, Andrisevic, 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 which comprises perforations as disclosed by Goodman as now modified by Gustafsson, Andrisevic, 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 location of the perforations and accordingly, the surgical site.
In regards to claim 10, Goodman as now modified by Gustafsson, Andrisevic, Namenye, and Haines discloses the invention as discussed above.
Goodman as now modified by Haines further discloses wherein the means for indicating the location of the perforations (30 of Haines) is glued on the limb sleeve (38 of Goodman; see Haines [0028] in reference to 30 being attached via adhesive material; glued is defined by the Merriam-Webster Dictionary as “to cause to stick tightly with or as if with glue” (see https://www.merriam-webster.com/dictionary/glue); when 30 of Haines is included onto 38 of Goodman, the adhesive material of 30 of Haines causes 30 to stick tightly onto the limb sleeve and is by definition “glued” on the limb sleeve).
In regards to claim 11, Goodman as now modified by Gustafsson, Andrisevic, Namenye, and Haines discloses the invention as discussed above.
In regards to the limitation(s) of wherein the limb sleeve comprises a sleeve starting layer which is folded in the length direction and glued on both sides of the folded parts to form the sleeve with a closed end and an open end, wherein the folded parts are glued up to a first distance from the open end, and wherein the perforations are at a second distance from the open end wherein the second distance is larger than or equal to the first distance, these limitations are drawn to an article of manufacture, and therefore the limitation(s) is/are considered to be a product-by-process limitation that is given patentable weight only for the structural limitations imparted to the final product by the process, since it has been held that “(e)ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP 2113). In the instant case, the limb sleeve as claimed is obvious in view of Goodman as now modified by Gustafsson, Andrisevic, Namenye, and Haines as discussed above. Therefore the product-by-process limitations of claim 11 are unpatentable even though the prior product was made by a different process.
In regards to claim 12, Goodman as now modified by Gustafsson, Andrisevic, Namenye, and Haines discloses the invention as discussed above.
Goodman further discloses wherein the limb sleeve (38) is glued to the main covering layer (34; see [col 4 ln 15-20] in reference to 48 attaching 40 to 34; see [col 4 ln 45-54] in reference to 48 being an adhesive-backed sheet which causes 38 to stick tightly with 34; thus, 38 by definition, is “glued” to 34 via the adhesive of 48).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goodman in view of Gustafson, Andrisevic, Namenye, and Haines as applied to claim 12 above, and further in view of Bainbridge (US 2011/0125112 A1).
In regards to claim 13, Goodman as now modified by Gustafsson, Andrisevic, Namenye, and Haines discloses the invention as discussed above.
Goodman as now modified by Gustafsson, Andrisevic, Namenye, and Haines does not disclose wherein the tourniquet element is glued in 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 (42; see [0074]; see figure 14a; 42 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, 42 is capable of being used as a tourniquet element); wherein the tourniquet element (42) is glued in the limb sleeve (2; see [0075] in reference to 42 being attached to 41 via adhesive which causes 42 to stick tightly in 2; thus, by definition, 42 is “glued” in 2).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tourniquet element as disclosed by Goodman as now modified by Gustafsson, Andrisevic, Namenye, and Haines and to have glued the tourniquet element in the limb sleeve as taught by Bainbridge in order to have provided an improved tourniquet element that would add the benefit of adhesively securing a position of the tourniquet element in the limb sleeve, thereby ensuring the tourniquet element does not change position with respect to the user during the surgical procedure.
Claim(s) 14-16 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 Namenye.
In regards to claim 14, 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) 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 15, Auerbach as now modified by Namenye discloses the invention as discussed above.
Auerbach further discloses 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).
In regards to claim 16, 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