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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
reference characters "125" and "175" have both been used to designate a grip region. In order to remedy this objection, Applicant could amend the drawings and specification to denote numeral 125 to be “the first grip region” and 175 “the second grip region”
reference characters "135" and "180" have both been used to designate a bend region. In order to remedy this objection, Applicant could amend the drawings and specification to denote numeral 180 to be “the first bend region” and 135 “the second bend region”
reference characters "145" and "197" have both been used to designate a coupling mechanism. In order to remedy this objection, Applicant could amend the drawings and specification to denote numeral 145 to be “the first coupling mechanism” and 197 “the second coupling mechanism”
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.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the:
“second post” such as in at least claim 8 must be shown or the feature(s) canceled from the claim(s). Applicant could remedy this drawing objection by including a numeral in the specification for the “second” post and adding this numeral to the drawing of FIG. 3 that appears to show an unlabeled “second” post across from first post 310 (see example figure provided by examiner below).
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“proximity sensor” such as in at least claim 18 must be shown or the feature(s) canceled from the claim(s)
No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 Objections
Claims 2, 12, 13, and 17 are objected to because of the following informalities:
Claim 2 line 2 reads “the cartridge is configured to extrude from, and contents of the cartridge are expelled…” and should likely read “the cartridge is configured to extrude from[[, ]] and a content[[s]] of the cartridge [[are]] is expelled…” for grammatical reasons and to provide antecedent basis for the “content/contents” of the cartridge
Claim 12 lines 3-4 read “…teeth configured to interface with the first set of teeth to ratchet… together to and cause the compression region to move…” and should likely read “…teeth configured to interface with the first set of teeth to ratchet… together [[to]] and to cause the compression region to move…” for grammatical reasons
Claim 13 lines 5-7 read “to allow the compression region to rotate about the pivot axis toward the holding region to release the tension the first rack and the second rack separate such that the first grip region and the second grip region can rotate away from each other” and should likely read “to allow the compression region to rotate about the pivot axis toward the holding region to release the tension, the first rack and the second rack separate such that the first grip region and the second grip region can rotate away from each other” for grammatical reasons
Claim 17: each instance of “extrude” should likely be replaced with “extends” because extrude refers to a shaping process of manufacturing while “extends” refers to a positional arrangement of a structure
Appropriate correction is required.
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:
Claim 1 lines 10-11 and Claim 20 lines 12-13: “a second coupling mechanism that is configured to couple to the first coupling mechanism”. Therefore, claims 1, 20, and all subsequent recitations of “second coupling mechanism” are interpreted under 112(f) according to the 3-prong test (unless otherwise explained below):
Prong 1: means or generic placeholder is recited— “a second coupling mechanism” is considered a generic placeholder for “means” because “a second coupling mechanism” has no specific structural meaning
Prong 2: functional language—configured to couple
Prong 3: not modified by other structural language in the claims—no structure is recited for how the second coupling mechanism functions in order to achieve coupling with the first coupling mechanism. Only the desired outcome of “to couple to” is recited.
According to Applicant’s disclosure under 112(f), the “second coupling mechanism that is configured to couple to the first coupling mechanism” is interpreted as ratcheting teeth on a rack or equivalents (see FIG. 3 and [0049]).
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.
Claim 20 is 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.
Regarding claim 20, lines 22-23 recite “a stopper mechanism”. However, “a stopper mechanism” was already introduced in line 19. Therefore, it is unclear to the examiner if the “a stopper mechanism” recited in lines 22-23 is the same structure as the stopper mechanism recited in line 19 OR if there are two distinct/separate stopper mechanisms of the device. According to Applicant disclosure, it appears there is only one stopper mechanism 115 of the device (see at least FIG. 3). Therefore, for purposes of examination, the examiner interprets claim 20 lines 22-23 read “[[a]] the stopper mechanism” in order to align with applicant disclosure of the device having only one stopper mechanism.
Claim Rejections - 35 USC § 102
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 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, 3-5, 7, and 12-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nilsson (U.S. PGPUB No. 2023/0346411).
Regarding claim 1, Nilsson discloses a device comprising:
an arm assembly that includes:
a compression region (upper surface of jaw 512, see ‘Modified FIG. 20’ below),
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a first grip region (504) that includes a first coupling mechanism (524), and
a first bend region (540) that couples (540 and 504 formed on same arm and therefore “coupled” as is disclosed by applicant in at least FIG. 3 of the current Application) the first grip region (504) and the compression region (upper surface of jaw 512, see ‘Modified FIG. 20’ above) such that the compression region (upper surface of jaw 512, see ‘Modified FIG. 20’ above) is canted (definition of canted is an angle. See ‘Modified FIG. 20i’ below with canted angle between first grip region and compression region relative a longitudinal axis drawn through the pivot point)
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from the first grip region (504), and a pivot axis (hinge/ rotation at 520, see [0120] & [0127-0128]: hinge 520 formed between 502/504 is pivotable) passes through the first bend region (540),
a body assembly that includes:
a holding region (lower surface of jaw 510, see ‘Modified FIG. 20’ above) configured to hold a cartridge (see [0123]: jaws of compression region can be loaded with any tool or instrument that comprises a single hinge mechanism and/or is in the shape of a cylindrical/ rod-like element and is therefore “configured to hold a cartridge”),
a second grip region (502) that includes a second coupling mechanism (528) that is configured to couple to (see [0122]: ratchet mechanism 524 formed of teeth members 524/528) the first coupling mechanism (524), and
a second bend region (538) that couples (538 and 502 formed on same arm and therefore “coupled” as is disclosed by applicant in at least FIG. 3 of the current Application) the second grip region (502) and the holding region (lower surface of jaw 510, see ‘Modified FIG. 20’ above) such that the holding region is canted (definition of canted is an angle. See ‘Modified FIG. 20ii’ below with canted angle between second grip region and holding region relative a longitudinal axis drawn through the pivot point)
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from the second grip region (502), and the second bend region (538) is coupled to (see [0129-0131]: 538 inserted into socket 540 to form hinge/ pivot 520) the first bend region (540) such that both the arm assembly and the body assembly pivot about the pivot axis (520, see [0132]); and
a stopper mechanism (530 & 522) coupled to (see [0124]: 530 couples jaw members 510/512 at tip 514) the holding region (lower surface of jaw 510, see ‘Modified FIG. 20’ above) and configured to control compression of the cartridge (see [0126] and [0132]: 530 applies tension to cause tip to close==configured to control compression of anything, such as a cartridge, disposed at the tip/jaw portions 510/512) by the compression region (upper surface of jaw 512, see ‘Modified FIG. 20’ above).
Regarding claim 3, Nilsson discloses the device of claim 1, and Nilsson further discloses wherein the device is in a loaded state (when 538/540 are brought to engage the first and second arm, see [0128] & [0130-0131]. Then 502/504 can be locked in place via 524/528, see [0122]) when the first coupling mechanism (524) is coupled to (see [0122]) the second coupling mechanism (528) and the stopper mechanism (530 & 522) is positioned to prevent the compression region from rotating about the pivot axis such that tension in the body assembly and the arm assembly is created (see [0126]: 530 carries tension between body &arm assemblies/ is in a first/loaded position until pivoting is achieved to close the jaws, including the compression region.).
Regarding claim 4, Nilsson discloses the device of claim 3, and Nilsson further discloses wherein the device is in a triggered state (see [0132]: when 502/504 brought together until hinge 520 is activated and 522 opens) when the stopper mechanism (530 & 522) is positioned (see [0132]: once 522 opens, 530 pivots/ is positioned such that it closes jaws 510/512, including compression and holding regions) to allow the compression region to rotate about the pivot axis toward the holding region to release the tension in the body assembly and the arm assembly (see [0132]).
Regarding claim 5, Nilsson discloses the device of claim 1, and Nilsson further discloses wherein the stopper mechanism (530 & 522, see FIG. 20) includes: a release mechanism (522) configured to move the stopper mechanism (530) from a first position to a second position (see [0132]: once 522 opens, 530 pivots/ moves from the first to second position such jaws 510/512 close), wherein in the first position (before 522 opens) the stopper mechanism (530) is configured to prevent the compression region from applying more than a holding pressure on the cartridge (see [0126]: 530 carries tension between body &arm assemblies/ is in a first/loaded position until pivoting is achieved to close the jaws. 530 does not move the compression region until pivoting occurs such as in [0132]. Therefore, stopper mechanism 530 “is configured to” prevent the compression region from applying any force, including “more than a holding pressure” on the cartridge), and in the second position (after 522 opens) the stopper mechanism (530) is configured to allow the compression region to apply pressure in excess of the holding pressure on the cartridge (see [0132]: once 522 opens, 530 pivots/ moves from the first to second position such that jaws 510/512 close and thus is configured to “allow” the compression region to apply pressure “in excess of the holding pressure on the cartridge”).
Regarding claim 7, Nilsson discloses the device of claim 5, and Nilsson further discloses wherein the stopper mechanism (530/522, see FIG. 20) is configured to rotate about a rotational axis (see dotted line as shown in ‘Modified FIG. 20i’ above) that passes through the stopper mechanism (through longitudinal center) and is parallel to (see dotted line as shown in ‘Modified FIG. 20i’ above parallel to pivot axis) the pivot axis (pivot axis at hinge 520).
Regarding claim 12, Nilsson discloses the device of claim 1, and Nilsson further discloses wherein the first coupling mechanism (524, see FIG. 20) includes a first rack (see [0122]: the ratchet mechanism 524 comprises one set of teeth 526 disposed on a surface==rack extending from the second member) with a first set of teeth (526), and the second coupling mechanism (528) includes a second rack (surface where 528 is disposed, see [0122]: a tooth 528 or teeth disposed on a surface extending from the first member 502) with a second set of teeth (see [0122]: a tooth 528 or teeth disposed on a surface extending from the first member 502) configured to interface with the first set of teeth (526) to ratchet the first grip region (504) and the second grip region (502) together to and cause the compression region (upper surface of jaw 512) to move toward the stopper mechanism (530, see [0122]: ratchet teeth lockable and see [0132]: force applied to 530 causes jaws, including compression region to come together. Thus, a user could squeeze loops 506/508 together until desired closure of jaws occurs and then lock first and second ratchet/teeth together and is therefore “configured to” interface to bring the grip regions together and cause the compression region to move toward the stopper mechanism).
Regarding claim 13, Nilsson discloses the device of claim 12, and Nilsson further discloses wherein the first rack (surface where 526 is disposed, see [0122]) and the second rack (surface on which 528 is disposed, see [0122]) are shaped such that: (1) they are in contact and can be ratcheted together while the stopper mechanism is positioned to prevent the compression region from rotating about the pivot axis such that tension in the body assembly and the arm assembly is created (see [0126]: 530 tensioning until pivoting is achieved. Ratcheting could occur before or after mating hinge as in [0128] and [0130-0131]), and (2) after the stopper mechanism is positioned to allow the compression region to rotate about the pivot axis toward the holding region to release the tension (see [0132]: once 522 opens, 530 pivots and closes jaws 510/512, including compression and holding regions) the first rack and the second rack separate such that the first grip region and the second grip region can rotate away from each other about the pivot axis (see [0122]: coupling mechanisms manually activatable and thus can separate at any time a user chooses such as after the jaws are closed.).
Regarding claim 14, Nilsson discloses the device of claim 1, and Nilsson further discloses wherein the arm assembly (see rejection of claim 1 above) is monolithic (see [0119] and [0124]).
Further, forming a device structure as a one-piece structure has been held to be an obvious matter of design choice over prior art teaching separate components that rigidly form the device structure (see MPEP § 2144.04.V.B). Therefore, whether the arm assembly is considered a single piece or multiple pieces, the device structure would not overcome the prior art of record.
Regarding claim 15, Nilsson discloses the device of claim 1, and Nilsson further discloses wherein the body assembly (see rejection of claim 1 above) is monolithic (see [0119] and [0124]).
Further, forming a device structure as a one-piece structure has been held to be an obvious matter of design choice over prior art teaching separate components that rigidly form the device structure (see MPEP § 2144.04.V.B). Therefore, whether the body assembly is considered a single piece or multiple pieces, the device structure would not overcome the prior art of record.
Regarding claim 16, Nilsson discloses the device of claim 1, and Nilsson further discloses wherein the stopper mechanism (530, see FIG. 20) is monolithic (see [0124]).
Further, forming a device structure as a one-piece structure has been held to be an obvious matter of design choice over prior art teaching separate components that rigidly form the device structure (see MPEP § 2144.04.V.B). Therefore, whether the stopper mechanism is considered a single piece or multiple pieces, the device structure would not overcome the prior art of record.
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.
Claims 1, 5-8, 10-11, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kendall et al. (U.S. Patent No. 9,943,673), hereinafter Kendall, in view of Nilsson (U.S. PGPUB No. 2023/0346411).
Regarding claim 1, Kendall discloses a device comprising:
an arm assembly (see Fig. 7B) that includes:
a compression region (structures at distal end of arm 701, such as 711 & 741, see ‘Modified FIG. 7B’ below),
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a first grip region (702) that includes a first coupling mechanism (730), and
a first bend region (see ‘Modified FIG. 7B’ above) that couples the first grip region (702) and the compression region (structures at distal end of arm 701) such that the compression region is canted (definition of canted is an angle. See ‘Modified FIG. 7b’ above with canted angle between first grip region and compression region relative the pivot point) from the first grip region (702), and a pivot axis passes through the first bend region (coupling 730 at bend region includes pivot, see col 15 lines 1-11);
a body assembly (703) that includes:
a holding region (713, see ‘Modified FIG. 7B’ above) configured to hold a cartridge (holding region 713 includes patch and therefore is “configured to” hold other elements, like a cartridge. See col 14 lines 38-46),
a second grip region (703) that includes a second coupling mechanism (753) that is configured to couple to (see col lines 15-22: 753 connected to 730) the first coupling mechanism (730), and
a second bend region (see ‘Modified FIG. 7B’ above) that couples the second grip region (703) and the holding region (713) such that the holding region (713) is canted (definition of canted is an angle. See ‘Modified FIG. 7b’ above with canted angle between second bend region and holding region in gray) from the second grip region (portion of arm 703 affixed at 753), and the second bend region (see ‘Modified FIG. 7B’ above) is coupled to the first bend region (see ‘Modified FIG. 7B’ above) such that both the arm assembly and the body assembly pivot about the pivot axis (see arm and body assemblies moving about pivot axis from Figs. 7a-f); and
a stopper mechanism (assembly including 731/732, arm extending to 763, and tab 763) coupled to the holding region (at least arm extending to 763 is coupled to holding region via arm 703) and configured to control compression of the cartridge by the compression region (see col 14 line 55- col. 15 line 28: stopper mechanism controls progression from Figs. 7a-f and is therefore “configured to control compression” on the cartridge).
Kendall is silent to the second coupling mechanism being a rack with teeth as interpreted under 112f above.
However, Nilsson teaches a device anticipating the current invention as claimed in claim 1 (see 102 rejection of claim 1 above), wherein the second coupling mechanism (528, see FIG.20) is a rack with teeth (see [0122]: a tooth 528 or teeth disposed on a surface extending from the first member 502) configured to couple to the first coupling mechanism (524, see [0122]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have provided the coupling mechanism disclosed in Kendall as a coupling ratchet formed of a rack and teeth as taught in Nilsson. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a general “coupling” between two arm-like elements disclosed in Kendall) for another known element (a rack and teeth forming a ratcheted coupling between two arm-like elements taught in Nilsson) in the art to obtain the predictable result of coupling two arm-like elements together (see MPEP § 2143.I.B), thus achieving the second coupling mechanism being a rack with teeth as interpreted under 112f above.
Regarding claim 5, the modified system of Kendall teaches the device of claim 1, and Kendall further discloses wherein the stopper mechanism (assembly including 731/732, arm extending to 763, and tab 763) includes: a release mechanism (763) configured to move (see col 14 lines 29-37 and col 14 line 55- col. 15 line 28) the stopper mechanism from a first position (see FIG. 7B) to a second position (see FIG. 7F), wherein in the first position (see FIG. 7B) the stopper mechanism is configured to prevent the compression region (structures at distal end of arm 701) from applying more than a holding pressure on the cartridge (in FIG. 7B, 711&741 not in contact with where cartridge would be placed and therefore no “more than a holding pressure” is applied), and in the second position (see FIG. 7F) the stopper mechanism is configured to allow the compression region (structures at distal end of arm 701) to apply pressure in excess of the holding pressure on the cartridge (see Fig. 7F with compression region in contact with holding region where cartridge is held and therefore is configured to “allow” a pressure in excess of a holding pressure. see col 14 line 55- col. 15 line 28: compression allowed determined by different design considerations such as size of aperture 741 and material choice of arms including 711).
Regarding claim 6, the modified system of Kendall teaches the device of claim 5, and Kendall further discloses wherein the release mechanism (763, see FIG. 7B) is a tab (as seen in FIG. 7B, definition of tab is “short projecting device”) that is moved by a user of the device (see col 14 lines 29-37).
Regarding claim 7, the modified system of Kendall teaches the device of claim 5, and Kendall further discloses wherein the stopper mechanism (assembly including 731/732, arm extending to 763, and tab 763, see FIG. 7B) is configured to rotate about a rotational axis (rotation along arm between 731 and 763) that passes through the stopper mechanism and is parallel to the pivot axis (as shown by rotational progression from FIGs. 7A-H).
Regarding claim 8, the modified system of Kendall teaches the device of claim 7, and Kendall further discloses wherein the stopper mechanism (assembly including 731/732, arm extending to 763, and tab 763, see FIG. 7B) includes a first post (731) and a second post (732) that are positioned along the rotational axis (rotation along arm between 731 and 763), and the first post (731) and the second post (732) are configured to couple (by way of longitudinal arm extensions along arms 701/703) to corresponding receptacles in the holding region (713).
Regarding claim 10, the modified system of Kendall teaches the device of claim 1, and Kendall further discloses wherein the arm assembly is narrower than (at least edge of 741 is narrower than the body assembly) the body assembly, such that the compression region (at least the edge of aperture 741 of the compression region) fits within (see FIG. 7F and col 15 lines 1-28.) the holding region (713).
Regarding claim 11, the modified system of Kendall teaches the device of claim 1, and Kendall further discloses wherein an interior surface of the second bend region faces an exterior surface of the first bend region (as seen in ‘Modified FIG. 7Bi’ below), and
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the compression region (711&741) and the first grip region (702) are on opposite sides (see side 1 and side 2 of ‘Modified FIG. 7Bi’ above. 702 circumferentially on side 1 of second grip region 703 when moving counter clockwise from second grip region. Compression region on side 2 when moving clockwise from second grip region) of the second grip region (703).
Regarding claim 17, the modified system of Kendall teaches the device of claim 1, and Kendall further discloses wherein the compression region (structures at distal end of arm 701 as seen in the box in ‘Modified FIG. 7B’ above) includes:
a body section (see portion of arm in ‘body section’ shown in ‘Modified FIG. 7Bii’ below);
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a compressor surface (711) that extrudes from the body section towards (711 extends longitudinally “toward” 713) the holding region (713); and
a catch (surface of compression region housing 731) that extrudes from an end of the body section (catch extends longitudinally along arm 701) such that when the device is in a loaded state the catch is in contact with the stopper mechanism (surface of compression region housing 731 always in contact with 731 of stopper mechanism and thus also in contact in “a loaded state”).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Nilsson as applied to claim 1 above, and further in view of Taylor et al. (U.S. PGPUB No. 2013/0006216), hereinafter Taylor.
Regarding claim 2, Nilsson discloses the device of claim 1, and Nilsson further discloses wherein the stopper mechanism (530, see FIG. 20) includes an aperture (530 forms opening/ aperture between jaws 510/512 by resilient bias described in [0126]) that a nozzle of the cartridge is configured to extrude from (see [0123]: jaws of compression region can be loaded with any tool or instrument that comprises a single hinge mechanism and/or is in the shape of a cylindrical/ rod-like element and therefore aperture of 530 between jaws is configured to have “a nozzle of the cartridge” extrude from).
Nilsson is silent to wherein the stopper mechanism includes an aperture that a nozzle of the cartridge is configured to extrude from “and contents of the cartridge are expelled from the nozzle of the cartridge subject to compression of the cartridge by the compression region.”
However, Taylor teaches a device comprising a cartridge (611, see FIG. 8) held between two arm-like elements (603/605) forming jaws (jaws formed distal of 631), wherein the device comprises a compression region (face of jaw 605, see ‘Modified FIG. 8’ below)
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, a holding region (face of jaw 603, see ‘Modified FIG. 8’ above), a stopper mechanism (623), wherein the stopper mechanism (623) includes an aperture (633) that a nozzle (627) of the cartridge (611) is configured to extrude from (see [0045]) and contents of the cartridge are expelled from the nozzle of the cartridge subject to compression of the cartridge by the compression region (as described in [0045]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have combined the device for compressing elements disposed between jaws at a distal end disclosed in Nilsson with the device compressing a deformable cartridge between jaws at a distal end as taught in Taylor.
A person of ordinary skill in the art could have combined the elements (Nilsson’s jaw device having an aperture for holding complementary devices used in combination with a deformable cartridge disposed between jaws and extending through an aperture as taught in Taylor) as claimed by known methods (providing the deformable cartridge and nozzle between the jaws as in Taylor) with no change to the respective functions (Nilsson’s device is used to compress any element between the jaws as in [0123] and Taylor uses jaws to compress a cartridge element to deliver medicinal fluid). Further, the combination would yield nothing more than predictable results (Nilsson’s device using the jaws to compress and deliver a medicament from a cartridge as taught in Taylor) to one of ordinary skill in the art, thus achieving wherein the stopper mechanism includes an aperture that a nozzle of the cartridge is configured to extrude from “and contents of the cartridge are expelled from the nozzle of the cartridge subject to compression of the cartridge by the compression region.”
Further, this combination would be advantageous to Nilsson because the device of Nilsson in view of Taylor could deliver a numbing medicinal agent to the surgical site, minimizing pain and discomfort for the patient.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kendall in view of Nilsson as applied to claim 7 above, and further in view of Cleveland et al. (U.S. PGPUB No. 2023/0191028), hereinafter Cleveland.
Regarding claim 9, the modified system of Kendall teaches the device of claim 7, and Kendall further discloses wherein the stopper mechanism (731/732, arm extending to 763, and 763, see FIG. 7B) includes a first connector (732, see FIG. 7B), and the body assembly (surface where 703 retains 773) holds a second connector (773, see FIG. 7F and col 14 lines 29-37: 773 held in position by arm 703) that are positioned to hold the stopper mechanism in the first position (see col 14 lines 29-37: 773 maintains position and col 14 lines 47-67: 732 maintains position).
Kendall is silent to the first and second connectors being magnets.
However, Cleveland teaches a device with a first connector (157,see FIG. 3B) and a second connector (156), wherein the connectors are magnetic connectors and taught as being obvious variants to other connection mechanisms (see [0097]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have substituted the snap-fit connectors disclosed in Kendall with a magnetic connector as taught in Cleveland. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a snap fit connection mechanism disclosed in Kendall) for another known element (a magnetic connection mechanism taught in Cleveland) in the art to obtain the predictable result of forming a secure engagement between structural components (see MPEP § 2143.I.B), thus achieving the first and second connectors being magnets.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Nilsson as applied to claim 1 above, and further in view of McILRATH (U.S. PGPUB No. 2022/0160971), hereinafter Mcilrath.
Regarding claim 18, Nilsson discloses the device of claim 1, but Nilsson is silent to “further comprising: a proximity sensor that is configured to detect when a nozzle of the cartridge has been inserted into a lower bowel of a patient by way of a rectum of the patient; and a controller configured to control a position of the stopper mechanism to allow compression of the cartridge based in part on a signal from the proximity sensor.”
However, Mcilrath teaches a device comprising an arm assembly (70, see FIG. 2) and a body assembly (see ‘Modified FIG. 6A’ below)
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that includes a holding region (collet/mating structure for grabbing barrel of cartridge, see also FIG.2) configured to grip a cartridge (12, see [0047] & [0054-0057]), the device further comprising a proximity sensor (14, see [0030]: 14 is proximity sensor) that is configured to detect when a nozzle (i.e.: distal end of cartridge including needle 18) of the cartridge (12) has been inserted into a lower bowel of a patient by way of a rectum of the patient (see [0034-0035] & [0048-0049]: proximity sensor notes position of nozzle relative tissue and therefore is “configured to detect” when the nozzle has been inserted into a lower bowel of a patient by way of a rectum by, in example, detecting the rectum tissue surface); and a controller (22, see FIG.5 and [0032-0033] & [0050]: 22 generates warnings and thus must have a controller) configured to control a position of a stopper mechanism (80) to allow compression of the cartridge based in part on a signal from the proximity sensor (see [0032-0033]: 22 receives and converts signals from proximity sensor and is therefore configured to “control position” of a stopper mechanism to allow compression of cartridge based on the signal & [0046-0048]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Nilsson to include a proximity sensor and a controller configured to control a structure based on a signal from the proximity sensor as taught by Mcilrath for the purpose of monitoring a cartridge nozzle at a distal end of the device (see [0028-0029]), which would be advantageous to Nilsson that is used in surgery for approaching specific anatomical structures (see [0050]), thus achieving “further comprising: a proximity sensor that is configured to detect when a nozzle of the cartridge has been inserted into a lower bowel of a patient by way of a rectum of the patient; and a controller configured to control a position of the stopper mechanism to allow compression of the cartridge based in part on a signal from the proximity sensor.”
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Nilsson as applied to claim 1 above, and further in view of Aklinvanh et al. (U.S. Patent No. 11,896,327), hereinafter Aklinvanh.
Regarding claim 19, Nilsson discloses the device of claim 1, but Nilsson is silent “wherein the stopper mechanism is electronically controlled by a user of the device.”
However, Aklinvanh teaches a device (see FIG. 2) including a stopper mechanism (11/ clamp mechanism of articulation joint as described in col 4 lines 45-48) for actuating jaws (16/18) of a distal end of the device, wherein the stopper mechanism (11) is electronically controlled by a user of the device (see col 4 lines 45-66: handle comprises trigger and motor for transmitting motion and therefore is “electronically controlled” via handle).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stopper mechanism actuating the jaw closure mechanism disclosed in Nilsson with the electronically controlled stopper mechanism for actuating a jaw closure mechanism as taught by Aklinvanh for the purpose of allowing clamping and delivery of cartridge material to occur at the same time (see col 4 lines 45-66), thus achieving “wherein the stopper mechanism is electronically controlled by a user of the device”.
Further, a person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a manually actuated jaw closure mechanism disclosed in Nilsson) for another known element (an electronically actuated jaw closure mechanism taught in Aklivanh) in the art to obtain the predictable result of opening and closing jaws at a distal end of a surgical device (see MPEP § 2143.I.B).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Nilsson (U.S. PGPUB No. 2023/0346411), in view of Taylor (U.S. PGPUB No. 2013/0006216).
Regarding claim 20, Nilsson discloses a method comprising:
loading a device (see FIGURE 20) with a cylindrical element (see [0123]: jaws of compression region can be loaded with any tool or instrument preferably cylindrical in shape), wherein the device (see FIGURE 20) comprises:
an arm assembly that includes:
a compression region (upper surface of jaw 512, see ‘Modified FIG. 20’ below),
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a first grip region (504) that includes a first coupling mechanism (524), and
a first bend region (540) that couples (540 and 504 formed on same arm and therefore “coupled” as is disclosed by applicant in at least FIG. 3 of the current Application) the first grip region (504) and the compression region (upper surface of jaw 512, see ‘Modified FIG. 20’ above) such that the compression region (upper surface of jaw 512, see ‘Modified FIG. 20’ above) is canted (definition of canted is an angle. See ‘Modified FIG. 20i’ below with canted angle between first grip region and compression region relative a longitudinal axis drawn through the pivot point)
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from the first grip region (504), and a pivot axis (hinge/ rotation at 520, see [0120] & [0127-0128]: hinge 520 formed between 502/504 is pivotable) passes through the first bend region (540),
a body assembly that includes:
a holding region (lower surface of jaw 510, see ‘Modified FIG. 20’ above) configured to hold a cartridge (see [0123]: jaws of compression region can be loaded with any tool or instrument that comprises a single hinge mechanism and/or is in the shape of a cylindrical rod and is therefore “configured to hold a cartridge”),
a second grip region (502) that includes a second coupling mechanism (528) that is configured to couple to (see [0122]: ratchet mechanism 524 formed of teeth members 524/528) the first coupling mechanism (524), and
a second bend region (538) that couples (538 and 502 formed on same arm and therefore “coupled” as is disclosed by applicant in at least FIG. 3 of the current Application) the second grip region (502) and the holding region (lower surface of jaw 510, see ‘Modified FIG. 20’ above) such that the holding region is canted (definition of canted is an angle. See ‘Modified FIG. 20ii’ below with canted angle between second grip region and holding region relative a longitudinal axis drawn through the pivot point)
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from the second grip region (502), and the second bend region (538) is coupled to (see [0129-0131]: 538 inserted into socket 540 to form hinge/ pivot 520) the first bend region (540) such that both the arm assembly and the body assembly pivot about the pivot axis (520, see [0132]), and
a stopper mechanism (530) coupled to (see [0124]: 530 couples jaw members 510/512 at tip 514) the holding region (lower surface of jaw 510, see ‘Modified FIG. 20’ above) and configured to control compression of a cartridge (see [0126] and [0132]: 530 applies tension to cause tip to close==configured to control compression of anything, such as a cartridge, disposed at the tip/jaw portions 510/512) by the compression region (upper surface of jaw 512, see ‘Modified FIG. 20’ above);
causing the first grip region (504) and the second grip region (502) to come together (such as by engaging 538/540, see [0128] & [0130-0131]. Then 502/504 can be locked in place via 524/528, see [0122]) such that the first coupling mechanism (524) couples to (see [0122]) the second coupling mechanism (528) and [[a]] the stopper mechanism (530) is in a first position to prevent the compression region from rotating about the pivot axis creating tension in the body assembly and the arm assembly (see [0126]: 530 carries tension between body &arm assemblies/ is in a first position until pivoting is achieved to close the jaws, including the compression region.); and
triggering (see [0132]: 502/504 brought together until hinge 520 is activated and 522 opens) a release mechanism (522) of the device to move the stopper mechanism (530) to a second position (see [0132]: once 522 opens, 530 pivots and closes jaws 510/512, including compression and holding regions) that allows the compression region to rotate about the pivot axis (see [0132]) toward the holding region to release the tension and compress the distal end (see [0132]: jaws close).
Nillson discloses the device capable of grasping any tool/ cylindrical rod element at the distal end (see [0123]), but Nillson is silent to loading specifically a “cartridge” and allowing the compression region to rotate about the pivot axis toward the holding region… to compress “the cartridge to cause the cartridge to expel its contents.”
However, Taylor teaches a method comprising loading a cartridge (611) into a device (see FIG. 8), wherein the device comprises a compression region (face of jaw 605, see ‘Modified FIG. 8’ below)
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and a holding region (face of jaw 603, see ‘Modified FIG. 8’ above) between two arm-like elements (603/605) forming jaws (jaws formed distal of 631), and allowing the compression region (face of jaw 605) to rotate about the pivot axis (631) toward the holding region (face of jaw 603) to compress the cartridge (611) to cause the cartridge to expel its contents (see [0045]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have combined the method using the device for compressing elements disposed between jaws at a distal end disclosed in Nilsson with the device compressing a deformable cartridge between jaws at a distal end as taught in Taylor.
A person of ordinary skill in the art could have combined the elements (Nilsson’s jaw device used in combination with a deformable cartridge disposed between jaws as taught in Taylor) as claimed by known methods (providing the deformable cartridge between the jaws as in Taylor) with no change to the respective functions (Nilsson’s device is used to compress any element between the jaws as in [0123] and Taylor uses jaws to compress a cartridge element to deliver medicinal fluid). Further, the combination would yield nothing more than predictable results (Nilsson’s device using the jaws to compress and deliver a medicament from a cartridge as taught in Taylor) to one of ordinary skill in the art, thus achieving the method including loading specifically a “cartridge” and allowing the compression region to rotate about the pivot axis toward the holding region… to compress “the cartridge to cause the cartridge to expel its contents.” Further, this combination would be advantageous to Nilsson because the device of Nilsson in view of Taylor could deliver a numbing medicinal agent to the surgical site, minimizing pain and discomfort for the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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