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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-12 and 14-16 in the reply filed on 7/29/2026 is acknowledged.
Claims 13 and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/29/2026.
Applicant's election with traverse of Species B2 in the reply filed on 7/29/2026 is acknowledged. The arguments are found persuasive, as Applicant argues the inventions of claim 1 and claim 9 can be the same invention, and the requirement between Species A and B is withdrawn.
Claims 1-12 and 14-16 are now pending examination.
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: “actuation instrument” in claim 9.
Claim 9 recites the limitation of an “actuation instrument”. The term “instrument” is used as a substitute for “means” and is modified by functional language “actuation”. There is no corresponding structure in the claim, therefore invoking 112(f). Based on the specification, the corresponding structure for “actuation instrument” is “an end effector with two or more jaws” (Paragraph 0055) or equivalents thereof, according to the species selection.
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 § 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.
Claim(s) 1-12 and 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoffman et al. (US 20060259041 A1) (noted on IDS).
Regarding claim 1, Hoffman discloses a band ligator (20) having a proximal end (550) and a distal end (Figure 2; Paragraph 0032), said band ligator comprising:
a band-mounting portion (200) (Figure 2; Paragraph 0032);
one or more ligating bands (210) mounted on said band-mounting portion (Figure 2; Paragraph 0033); and
an actuator element (220) operably associated with said one or more ligating band to actuate said band ligator to deploy a ligating band distally from said band-mounting portion (Figure 2, 3A-B; Paragraph 0033);
wherein said band ligator and said actuator element are configured to be deployed within a patient without an actuation instrument (biopsy forceps) operably engaging said actuator element for user access to actuate said actuator element (the biopsy forceps are fully capable of being initially operatively associated with said band ligator after said band ligator has been delivered to tissue to be ligated, as they can be inserted after the bands are placed to potentially reposition or adjust the bands.).
Regarding claim 2, Hoffman further discloses (Original) The band ligator of claim 1, wherein the proximal end of said band ligator is configured to be mounted on a distal end of an elongate member (10) for delivery to tissue to be ligated with said actuator element adjacent the distal end of the elongate member and the proximal end of said band ligator (Paragraph 0030).
Regarding claim 3, Hoffman further discloses wherein said band ligator defines a proximal lumen (240) open along the proximal end of said band ligator and said actuator element extends across the proximal lumen of said band ligator (Figure 2A, 3D; Paragraph 0033).
Regarding claim 4, Hoffman further discloses wherein said actuator element extends across said proximal lumen within said proximal lumen (Figure 2A, 3D; Paragraph 0033).
Regarding claim 5, Hoffman further discloses wherein said actuator element has a free end (proximal end of 220) coupled to the proximal end of said band ligator (Paragraph 0034).
Regarding claim 6, Hoffman further discloses a filament (208+209) interengaging with said one or more ligating bands and extending from a distal band to a proximal band along the exterior of said band ligator to be operably coupled with said actuator element at the proximal end of said band ligator (Figure 3D; Paragraph 0040-41).
Regarding claim 7, Hoffman further discloses wherein said band ligator does not include components extending proximally beyond the proximalmost end of said band ligator (there is no disclosure of the any components extending beyond the proximalmost end of the band ligator, thus they are seen as not extending as such).
Regarding claim 8, Hoffman further discloses wherein said actuator element does not extend proximally beyond the proximalmost end of said band ligator (there is no disclosure of the actuator element extending beyond the proximalmost end of the band ligator, thus it is seen as not extending as such) (Paragraph 0034).
Regarding claim 9, Hoffman discloses a band ligator system comprising:
a band ligator (20) (Figure 2; Paragraph 0032) comprising:
a band-mounting portion (200) (Figure 2; Paragraph 0032);
one or more ligating bands (210) mounted on said band-mounting portion (Figure 2; Paragraph 0033); and
an actuator element (220) operably associated with said one or more ligating band to actuate said band ligator to deploy a ligating band distally from said band-mounting portion (Figure 2, 3A-B; Paragraph 0033);
and an actuation instrument (biopsy forceps) formed separately and independently of said band ligator (Paragraph 0028) (As indicated above, the limitation “actuation instrument” invokes 112(f). The corresponding structure in Hoffman is a pair of biopsy forceps, which is equivalent to jaws, as disclosed in the present disclosure.);
wherein:
said band ligator is configured to be mounted with respect to an elongate member (11) for delivery to tissue to be ligated without the actuation instrument operatively associated with said band ligator (Figure 3A; Paragraph 0032); and
said actuation instrument is configured to be initially operatively associated with said band ligator after said band ligator has been delivered to tissue to be ligated (the biopsy forceps are fully capable of being initially operatively associated with said band ligator after said band ligator has been delivered to tissue to be ligated, as they can be inserted after the bands are placed to potentially reposition or adjust the bands.).
Regarding claim 10, Hoffman further discloses wherein: said band ligator is configured for use with a medical instrument (100), the elongate member extending distally from a control handle (550) of the medical instrument (Figure 1B; Paragraph 0032); and when said band ligator is delivered to tissue to be ligated, mounted with respect to the elongate member of the medical instrument, said actuator element is positioned distal to the control handle of the medical instrument without said actuation instrument extending proximally to the control handle of the medical instrument (Figure 1B; 7A-B).
Regarding claim 11, Hoffman further discloses wherein said actuation instrument is insertable through a lumen extending through the elongate member after said band ligator has been delivered to tissue to be ligated to operably engage said actuator element to actuate said actuator element to deploy a ligating band (Paragraph 0028).
Regarding claim 12, Hoffman further discloses wherein said actuation instrument includes an end effector configured to grasp and manipulate said actuator element (forceps are structured with an end effector capable of grasping thus the biopsy forceps of Hoffman would be fully capable of grasping and manipulating the actuator element.).
Regarding claim 14, Hoffman further discloses wherein said end effector includes a plurality of jaws movable relative to one another between an open configuration and a closed configuration (Paragraph 0028) (forceps inherently include two jaws movable between an open configuration and a closed configuration).
Regarding claim 15, Hoffman further discloses wherein said actuation instrument includes a handle movable to actuate said end effector to grasp said actuator element (Paragraph 0028) (forceps inherently include a handle to actuate the end effector, which is fully capable of grasping said actuator element).
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.
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) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman as applied to claim 9 above, and further in view of Jinno et al. (US 20100198253 A1).
Regarding claim 16, Hoffman discloses the system of claim 9 but fails to explicitly disclose wherein said actuation instrument includes a handle configured to move in only one direction to deploy one ligating band at a time from said band ligator.
However, Jinno is directed to forceps and teaches it is known for forceps to have one degree of freedom, thus the forceps including the handle are configured to move in one direction (Paragraph 0008). As a result, said handle would be configured to deploy one ligating band at a time from said band ligator.
One of ordinary skill in the art would know it is typical of forceps to move in one direction. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). "[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does." KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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/Z.J./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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