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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on February 17, 2026, is acknowledged. The traversal is on the ground(s) that Eizenfeld fails to disclose whereby the axially compacted sleeve is provided in the handle and whereby the proximal end of the sleeve is pulled proximally. This is not found persuasive because Eizenfeld shows in Figs. 9-11 a handle body 74 with the sleeve compacted therein. The detachable portion 72 moves proximally relative to the endoscope and handle body. The feature is not a special technical feature because it does not represent a contribution over the prior art. Furthermore, Applicant has highlighted the propriety of Lack of Unity requirement in arguing the function of the device over the structure. It is possible that Eizenfeld functions differently from the claimed method, but as far as the structure of the claimed apparatus, there is no patentable distinction. The inclusion of claim 28 does not change the requirement.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-6, 8-10, 19, 24, and 26-28 are addressed on the merits.
Claims 11-16 and 21 are withdrawn.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "209" and "225" have both been used to designate the coupling member/expandable head. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
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.
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: “coupling element” in claim 19 (“element” is a substitute for means; the term is modified by functional language in that the element is configured to couple the distal end of the endoscope to a distal end of an add-on tube; and the term is not modified by structure sufficient to perform the claimed function). The disclosure indicates that the coupling means is an expandable head.
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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6, 8-10, 19, 24, and 26-28 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.
The term “thin” in claim 1 is a relative term which renders the claim indefinite. The term “thin” 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. While the Specification provides examples related to the elongate protective sleeve, these examples of thickness do not constitute a definition for “thin”. Without clear boundaries, the Examiner asserts that a person having ordinary skill in the art would not be able to determine the metes and bounds of the claim. Appropriate correction is required.
Claim 8 recites the limitation "said add-on tube". There is insufficient antecedent basis for this limitation in the claim. The claim does not depend from claim 4 such that reference to “said add-on tube” creates ambiguity as to whether claim 8 was intended to depend from claim 4, this is a different add-on tube, or if this is simply an add-on tube. The Examiner assumes there is only one add-on tube. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 8-9, 19, and 28 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Bar-Or (US 2007/0255101).
Regarding Claim 1, Bar-Or discloses:
A handle for at least partially covering an endoscope with a protective thin sleeve, the handle comprising:
a handle body (54) shaped and sized to receive a distal portion of an endoscope therein (see Fig. 3C, for example, showing an endoscope inserted into 54);
a detachable portion (30) at a proximal end of said handle body, said detachable portion configured to detach from said handle body (30 detaches from 54 using 84 and 40 or 42) and to be moved proximally along at least a portion of a length of the endoscope received within said handle body (the detachable portion 30 can be detached from the handle and can move proximal relative to the scope as shown in Figs. 6-7); and
a thin elongate protective sleeve (52) axially compacted within said handle body (see Fig. 3C showing the sleeve 52 compacted within 54), a proximal end of said sleeve coupled to said detachable portion (52 is coupled to 30 at 48 and 50), wherein movement of said detachable portion proximally along said endoscope pulls on said proximal end of said sleeve and extends said sleeve in length from its axially compacted state to a lengthened state, thereby covering said at least a portion of the length of said endoscope (the sleeve 52 is coupled to the detachable portion such that the sleeve unfolds and covers the scope, see Paragraph 0049).
Regarding Claim 2, Bar-Or further discloses wherein said detachable portion comprises a ring (30 is generally ring-shaped to fit within opening 66) which is separable from said handle body, said ring sized to circumferentially surround an endoscope received within said handle body (see Figs. 2 and 3C showing 30 surrounding the endoscope).
Regarding Claim 3, Bar-Or further discloses wherein said handle body accommodates an expandable head (38) sized to receive a distal end of the endoscope therein (see Fig. 2), said expandable head coupled to a distal end of said sleeve (see Paragraph 0033).
Regarding Claim 8, Bar-Or further discloses wherein said detachable portion further comprises a gripper (32) which is separable from said handle body (32 is part of 30 and can be removed from the handle body), the gripper circumferentially surrounding said add-on tube and an endoscope received within the handle (neither the add-on tube nor endoscope are structural elements of the claimed handle; as seen in Fig. 2, the gripper 32 surrounds the tubular member inserted therein), the gripper configured to slide proximally to align and approximate said add-on tube to said endoscope (the gripper can slide with 30 along the tubular member, see Fig. 7, aligning anything inserted therein).
Regarding Claim 9, Bar-Or further discloses wherein said sleeve is formed of a flexible material (Paragraph 0045).
Regarding Claim 19, Bar-Or further discloses wherein said handle body accommodates a coupling element (38) configured to couple the distal end of the endoscope to a distal end of an add-on tube (38 snaps onto the distal end of an inserted tubular member).
Regarding Claim 28, Bar-Or further discloses wherein said sleeve has an open distal end (the open end of 52 passes between cap 28 and forward end 34 and is anchored in place using 38).
Claims 1-4, 6, 8-9, and 19 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Eizenfeld et al. (US 2006/0111611).
Regarding Claim 1, Eizenfeld discloses:
A handle for at least partially covering an endoscope with a protective thin sleeve, the handle comprising:
a handle body (74) shaped and sized to receive a distal portion of an endoscope therein (see Figs. 9-11, for example, showing an endoscope inserted into 74);
a detachable portion (72) at a proximal end of said handle body, said detachable portion configured to detach from said handle body (72 detaches from 74 as seen in Fig. 11) and to be moved proximally along at least a portion of a length of the endoscope received within said handle body (the detachable portion 72 can be detached from the handle and can move proximal relative to the scope as shown in Fig. 11); and
a thin elongate protective sleeve (80) axially compacted within said handle body (see Figs. 9-11 showing the sleeve 80 compacted at 82), a proximal end of said sleeve coupled to said detachable portion (see Fig. 11), wherein movement of said detachable portion proximally along said endoscope pulls on said proximal end of said sleeve and extends said sleeve in length from its axially compacted state to a lengthened state, thereby covering said at least a portion of the length of said endoscope (the sleeve 80 is coupled to the detachable portion such that the sleeve unfolds and covers the scope as seen in Fig. 11).
Regarding Claim 2, Eizenfeld further discloses wherein said detachable portion comprises a ring (34) which is separable from said handle body (34 detaches when 72 detaches), said ring sized to circumferentially surround an endoscope received within said handle body (see Figs. 9-11).
Regarding Claim 3, Eizenfeld further discloses wherein said handle body accommodates an expandable head (76) sized to receive a distal end of the endoscope therein (see Figs. 9-11 showing scope 22 inserted into 76), said expandable head coupled to a distal end of said sleeve (76 is coupled to 80 via the components 72 and 74).
Regarding Claim 4, Eizenfeld further discloses wherein said expandable head is coupled to a distal end of an add-on tube to be inserted along with the endoscope into the body (76 can couple to 62; see also Paragraph 0056 indicating that the embodiments can be combined such that the tube in Fig. 8 can be inserted into the sheath 76 in Figs. 9-11), said expandable head configured to hold a distal end of the endoscope together with said distal end of said add-on tube (see Figs. 8-11).
Regarding Claim 6, Eizenfeld further discloses wherein said expandable head is elastically expanded (functional language/product by process; how the head is expanded to reach the desired size does not change the structure of the head) to a diameter of between 10-20 mm to fit endoscopes having a diameter of between 9-15 mm (see Paragraph 0039).
Regarding Claim 8, Eizenfeld further discloses wherein said detachable portion further comprises a gripper (34) which is separable from said handle body (34 detaches when 72 detaches), the gripper circumferentially surrounding said add-on tube and an endoscope received within the handle(neither the add-on tube nor endoscope are structural elements of the claimed handle; as seen in Fig. 11, the gripper 34 surrounds the tubular member inserted therein), the gripper configured to slide proximally to align and approximate said add-on tube to said endoscope (the gripper can slide with 72 along the tubular member, see Fig. 11, aligning anything inserted therein).
Regarding Claim 9, Eizenfeld further discloses wherein said sleeve is formed of a flexible material (the sleeve is bunched in a compacted region 82).
Regarding Claim 19, Eizenfeld further discloses wherein said handle body accommodates a coupling element (76) configured to couple the distal end of the endoscope to a distal end of an add-on tube (76 can couple to 62; see also Paragraph 0056 indicating that the embodiments can be combined such that the tube in Fig. 8 can be inserted into the sheath 76 in Figs. 9-11).
Claim Rejections - 35 USC § 103
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.
Claims 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Bar-Or (US 2007/0255101) in view of Eizenfeld et al. (US 2006/0111611).
Bar-Or discloses the invention substantially as claimed as stated above.
Regarding Claim 6, Bar-Or does not explicitly disclose wherein said expandable head is elastically expanded to a diameter of between 10-20 mm to fit endoscopes having a diameter of between 9-15 mm. Eizenfeld teaches sizing an expandable head portion to be about 20 mm to fit endoscopes of about 13 mm. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Bar-Or’s expandable head to be sized as taught in Eizenfeld. Such a modification ensures the head fits known endoscopes.
Regarding Claim 10, Bar-Or does not explicitly disclose wherein said sleeve is transparent at least at a distal end face of said sleeve. Eizenfeld teaches placing a transparent window (Paragraph 0040) at the distal end of the sleeve so viewing optics may observe the interior of the body. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Bar-Or’s sleeve to include Eizenfeld’s transparent portion. Such a modification provides a clear portion so that the scope’s viewing optics can observe the interior of the body.
Allowable Subject Matter
Claims 5, 24, and 26-27 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 5 and 26 refer to a plunger in combination with the other elements for engaging with the expandable head. Neither Bar-Or nor Eizenfeld include such a feature. Bar-Or’s device includes a cap making a plunger difficult to incorporate. Eizenfeld’s expandable head has seemingly no need of a plunger. Also, the Examiner did not find a reference that taught using a plunger in this way that would then be able to be incorporated into the primary references. For at least these reasons, the claims overcome the prior art. Claim 27 depends from claim 26 and, therefore, also overcomes the prior art.
Claim 24 includes additional structural features related to the coupling element. These features are not considered obvious because the primary references’ coupling element would not include the interlocking features and the pocket. Bar-Or’s coupling element appears to be little more than a rubber band. Eizenfeld’s coupling element 76 is a protective sheath itself. Including interlocking portions as claimed would create openings for contaminants. That defeats the purpose of the sheath such that including these features would not be obvious. For at least these reasons, the claim overcome the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795