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 .
Response to Arguments
Applicant’s arguments filed 4/8/2026 with respect to the rejection of Independent Claim 18 under 35 USC 102 as anticipated by US 2007/0078475 A1 to Bodduluri et al. (“Bodduluri”) have been fully considered and are persuasive to the extent the Examiner agrees that Bodduluri does not disclose at least one suction conduit “made of a material transparent to light” and “said command and image acquisition means comprising at least one still camera which is configured to frame the contents of said analysis and verification portion.” Therefore, the rejection has been withdrawn. However, these elements were previously recited by dependent Claims 21 and 30, which have been canceled by way of the current amendment with their subject matter incorporated into Independent Claim 18. Claims 21 and 30 were previously rejected in view of US 2019/0054283 A1 to Knowlton (“Knowlton”) and US 2009/0306680 A1 to Qureshi et al. (“Qureshi”), respectively. These rejections are maintained. Accordingly, Claim 18 stands rejected under 35 USC as unpatentable over Bodduluri, Knowlton and Qureshi.
Applicant’s arguments regarding Independent Claim 18 are broken into three points on Pg. 8-9 of Applicant’s 4/8/2026 Remarks. Each of Applicant’s arguments is addressed below:
Applicant argues first that Bodduluri does not disclose a suction conduit “made of a material transparent to light” that is “interposed between said hollow cannula and said punch.” The Examiner agrees that Bodduluri does not disclose a suction conduit “made of a material transparent to light.” However, Knowlton teaches such a transparent material. Applicant’s argument that Bodduluri’s suction conduit is not “interposed between said hollow cannula and said punch” is not persuasive. Bodduluri’s “vacuum source … selectively placed in communication with the harvesting cannula lumen” is “interposed between said hollow cannula and said punch” by virtue of the relative positions of Bodduluri’s “punch” and “hollow cannula” (see Bodduluri at Para. [0012]).
Applicant’s arguments to the contrary appear to focus on where suction is created. It is not clear in what sense Applicant believes this to differentiate Claim 18 from Bodduluri with respect to the recited suction conduit.
Applicant argues second that Bodduluri does not teach a still camera or any image acquisition device that is “configured to frame the contents of said analysis and verification portion.” Applicant’s arguments are not persuasive. Qureshi rather than Bodduluri is cited for this teaching. Qureshi teaches such a still camera at Para. [0058], which states “[t]he camera(s) may have viewfinders such that when attached to the glasses it allows the physician to view exactly what the cameras are imaging.” Qureshi’s “viewfinders” perform such framing as claimed.
Third, Applicant argues that Bodduluri does not disclose “at least one screen defined by an analysis and verification unit external to said handling device for displaying said images on an enlarged scale showing the contents of said analysis and verification portion in such a manner as to examine and verify properties of said at least one follicular unit directly from said analysis and verification portion before its implantation” because “Bodduluri does not disclose a screen or display configured to show enlarged images of the contents of an analysis and verification portion to permit examination and verification of follicular unit properties before implantation” (Applicant’s Remarks at Pg. 10). However, the term “for displaying said images on an enlarged scale showing the contents of said analysis and verification portion in such a manner as to examine and verify properties of said at least one follicular unit directly from said analysis and verification portion before its implantation” is being interpreted as an intended use of the recited “screen,” as noted at Para. 32(b)(i) of the Non-Final Office Action dated 1/9/2026. Bodduluri’s Para. [0058] describes a similar screen and a similar use.
Applicant argues that “Applicant's claimed device integrates a transparent viewing region and an imaging system into the handling device itself so that the operator can inspect the quality of each harvested follicular unit in real time, directly within the device, before proceeding with implantation, thereby enabling a continuous explantation/inspection/implantation cycle without the need to remove the follicular unit from the device for manual examination,” whereas “Bodduluri, by contrast, employs cameras only to visualize the external scalp surface and cannula insertion depth and does not teach or suggest any structure for inspecting the harvested follicular unit while it is held within the device” (Applicant’s Remarks at Pg. 10). The Examiner agrees in principle with this distinction, but disagrees that the language of Claim 18 reflects this difference. Were Claim 18 to more narrowly recite the structural mechanisms responsible for the difference, Applicant’s arguments may be persuasive.
Applicant’s arguments regarding the rejection of dependent Claims 19, 22-23, 25, 27-28, 31 and 34 are based on Applicant’s arguments regarding Independent Claim 18. Applicant’s arguments have been fully considered but are not persuasive for the same reasons as explained above.
Applicant’s arguments regarding the interpretation of the terms “mechanical interconnection means for kinematic association” and “an analysis and verification portion” under 35 USC 112(f) have been fully considered and are persuasive. As the term “mechanical interconnection means for kinematic association” is no longer used in Claim 18, the term is no longer being interpreted under 35 USC 112(f). The term “an analysis and verification portion” now contains a recitation elaborating upon what the device “comprises.”
Applicant’s arguments regarding the rejection of Claim 18 under 35 USC 112(a) based on the interpretation of the terms “mechanical interconnection means for kinematic association” and “an analysis and verification portion” under 35 USC 112(f) without corresponding structure being described in the Specification have been fully considered and are persuasive for the same reasons.
Applicant’s arguments regarding the interpretation of the term “an analysis and verification unit” under 35 USC 112(f) have been fully considered but are not persuasive. Claim 18 now recites “at least one screen defined by an analysis and verification unit,” which Applicant notes is supported by Pg. 7, Ln. 22-24 of the Present Specification. However, that “at least one screen” is “defined by an analysis and verification unit” does not elaborate on what the “an analysis and verification unit” which the “at least one screen” is defined by actually is. No structure has been added via the amendment, and no structure is described in the Present Specification.
Applicant’s arguments regarding the rejection of Claims 20, 21, 29, 30, 32 and 33 under 35 USC 112(a) based on the interpretation of the term “an analysis and verification unit” under 35 USC 112(f) without corresponding structure being described in the Specification have been fully considered but are not persuasive for the same reasons.
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.
The following limitations are being interpreted under 35 USC 112(f):
Claim 18, “incision means,” which is being interpreted as “a needle … or other instrument provided with a distal cutting edge…” (Present Specification at Pg. 5, Ln. 15-16) and functional equivalents thereof.
Claim 18, “drive means,” which is being interpreted as “micro-motors of the brushless type” (Present Specification at Pg. 5, Ln. 8-9) and functional equivalents thereof.
Claim 18, “mechanical coupling members,” which is being interpreted as a bayonet fitting (Present Specification at Pg. 4, Ln. 28-29) and functional equivalents thereof.
Claim 27, “suction means,” which is being interpreted as “a solenoid valve 14 associated with the hollow cannula 12 and associable with an external suction apparatus” (Present Specification at Pg. 6, Ln. 21-24) and functional equivalents thereof.
Claim 29, “command and image acquisition means,” which is being interpreted as “control elements for the operator (with which he or she can activate the handpiece 1 in conformance with the current specific operating phase), in addition to specific optical sensors of the type of a micro-camera, a still camera, a photocell and the like” (Present Specification at Pg. 7, Ln. 12-16) and functional equivalents thereof.
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 18, “an analysis and verification unit,” regarding which the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function (see below).
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 18, and Claims 19, 22-23, 25, 27-28, 31 and 34 by dependency, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Further regarding Claim 18, Claim 18 recites “an analysis and verification unit.” The Present Specification is silent with regard to what the “analysis and verification unit” is. The term “an analysis and verification unit” is being interpreted under 35 USC 112(f), but the Present Specification fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The phrase “analysis and verification unit appears on the Present Specification only three times, all on Pg. 8 of the Present Specification. Representatively, the Present Specification states “With regard to the screen, … it is defined by an analysis and verification unit external to the handle device 1 and the image acquisition means 18 are functionally associated therewith for sending the images acquired and displaying them on this screen” (Present Specification at Pg. 7, Ln. 30 through Pg. 8, Ln. 4). One of ordinary skill in the art would be unable to discern the structure of the “analysis and verification unit” from its description in the Present Specification.
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 18, and Claims 19, 22-23, 25, 27-28, 31 and 34 by dependency, 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.
Regarding Claim 18, Claim 18 recites “at least one screen defined by an analysis and verification unit external to said handling device for displaying said images on an enlarged scale showing the contents of said analysis and verification portion.” It is grammatically unclear whether the “at least one screen” or the “analysis and verification unit” is “external to said handling device.”
For purposes of this Office Action, the above limitation is being interpreted to mean that the “at least one screen” is “external to said handling device.”
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 18, 22-23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2007/0078475 A1 to Bodduluri et al. (“Bodduluri”) in view of previously cited US 2019/0054283 A1 to Knowlton (“Knowlton”) and previously cited US 2009/0306680 A1 to Qureshi et al. (“Qureshi”).
Regarding Independent Claim 18, Bodduluri teaches:
A handling device with increased functionality for hair transplantation operations, (Title, “Tool assembly for harvesting and implanting follicular units;” Figs. 1 and 2, “image-guided robotics system 25”);
which comprises a main body with an elongated shape structure which is ergonomically shaped to be gripped by a hand of an operator; (Fig. 3, “three-part tool 32;” Para. [0009], “The tool assembly may be hand-held and positioned;” Para. [0011]; Para. [0030]);
said main body being provided with incision means and with explantation and implantation means for transplantation of at least one follicular unit from the scalp of a patient to a tissue to be treated; (Para. [0030], “More particularly, the three-part tool 32 includes an outer (“implanting”) cannula 36 having an open, tissue-piercing (e.g., beveled) distal end 37 used for making incisions at recipient (implantation) sites in a body surface. An inner (“harvesting”) cannula 38 is coaxially positioned in an interior lumen of the implanting cannula 36, and has an open, tissue-coring (e.g., rough or serrated) distal end 40. The harvesting cannula 38 has an interior lumen appropriately sized for harvesting singular human hair follicular units by coring the respective follicular units and extracting them from a body surface (typically but not necessarily a scalp).”);
Bodduluri’s “implanting cannula 36” is such an “incision means” as claimed.
Bodduluri’s “harvesting cannula 38” is such an “explantation and implantation means” as claimed.
wherein said main body comprises at least one distal section and at least one proximal section which are mutually detachably associated; (Fig. 4; Para. [0032], “The elongate body 46 further includes a recessed section 44 located proximally of the flanges 48, which seats an annular retaining member 50 for detachably-coupling (via a snap-fit type connection) with the tubular drive member (proximal of the slots that engage flanges 48), thereby retaining the harvesting cannula 38 in position when the tool 32 is coupled with the motor dive assembly 60.”);
As shown in Fig. 4, “annular retaining member 50” defines a “proximal section” (in the “right” direction on the page from “annular retaining member 50”) and a “distal section” (in the “left” direction on the page from “annular retaining member 50”). Those portions are “mutually detachable” via “annular retaining member 50.”
said proximal section enclosing inside drive means which are associated with said incision means and with said explantation and implantation means for their functional movement; (Para. [0031], “With reference also to FIGS. 4 and 5, the tool assembly 30 includes a motor drive assembly 60 mounted in the housing 22 and configured to receive and operatively engage the component parts of the three-part tool 32. … The tubular sleeve 65 engages a rack-and-pinion drive mechanism 81 driven by a first motor 62 of the motor drive assembly 60, so that, when the hub 34 is coupled to the gripper 63, the motor 62/drive mechanism 81 provide axial (i.e., reciprocating) motion of the implanting cannula 36 relative to the harvesting cannula 38 (and also relative to the tool assembly housing 22/24).”);
said incision means and said explantation and implantation means being associated with said distal section in such a manner as to be separable from said drive means and be subjected to surgical sterilization procedures; (Para. [0031], “In particular, the implanting cannula 36 is fixedly attached to a proximal hub 34, including a distal facing tapered portion 34 a and a proximally directed engagement portion 34 b. The engagement portion 34 b may be detachably-coupled (snap-fit) with a resilient gripper 63 extending from a tubular sleeve 65 in the motor drive assembly 60;” Para. [0032], “The elongate body 46 further includes a recessed section 44 located proximally of the flanges 48, which seats an annular retaining member 50 for detachably-coupling (via a snap-fit type connection) with the tubular drive member (proximal of the slots that engage flanges 48), thereby retaining the harvesting cannula 38 in position when the tool 32 is coupled with the motor dive assembly 60.”);
The term “and be subjected to surgical sterilization procedures” is being interpreted as an intended use. Bodduluri’s incision means and said explantation and implantation means may be subjected to surgical sterilization procedures post-detachment.
between interface surfaces of said proximal section and of said distal section there being at least one pair of mechanical coupling members, each pair comprising a proximal coupling member disposed at the interface surface of said proximal section and a corresponding distal coupling member disposed at the interface surface of said distal section, for kinematically coupling said drive means with said incision means and with said explantation and implantation means; (Para. [0031], “In particular, the implanting cannula 36 is fixedly attached to a proximal hub 34, including a distal facing tapered portion 34 a and a proximally directed engagement portion 34 b. The engagement portion 34 b may be detachably-coupled (snap-fit) with a resilient gripper 63 extending from a tubular sleeve 65 in the motor drive assembly 60;” Para. [0032], “The elongate body 46 further includes a recessed section 44 located proximally of the flanges 48, which seats an annular retaining member 50 for detachably-coupling (via a snap-fit type connection) with the tubular drive member (proximal of the slots that engage flanges 48), thereby retaining the harvesting cannula 38 in position when the tool 32 is coupled with the motor dive assembly 60.”).
Bodduluri’s “snap-fit type connection” forms such a “pair of mechanical coupling members” as claimed.
said explantation and implantation means comprising a hollow cannula associated at one end thereof with a punch of a surgical type that can move about a longitudinal axis thereof via actuation of said drive means for a core sampling of said at least one follicular unit; (Para. [0038], “ An inner (“harvesting”) cannula 38 is coaxially positioned in an interior lumen of the implanting cannula 36, and has an open, tissue-coring (e.g., rough or serrated) distal end 40. The harvesting cannula 38 has an interior lumen appropriately sized for harvesting singular human hair follicular units by coring the respective follicular units and extracting them from a body surface (typically but not necessarily a scalp).”).
said handling device further comprising an analysis and verification portion which is associated with said main body proximate to said explantation and implantation means and is adapted to contain said at least one follicular unit, (Para. [0054], “In further embodiments, a proximal end of the cannula assembly 110 may be coupled to a vacuum unit (not shown) located within the positioning assembly 106. In such cases, the vacuum unit creates suction within the lumen 217 of the harvesting cannula 200, to thereby pull the target follicular unit 302 away from its underlying tissue as the harvesting cannula 200 is removed from the patient.”).
The limitation “an analysis and verification portion” is being interpreted to mean a collection of parts purposed for “analysis and verification,” which collection of parts may include a “suction conduit.”
Bodduluri’s “vacuum unit” is such an “analysis and verification portion” as claimed.
said analysis and verification portion comprising at least one suction conduit … which is directly associated with said explantation and implantation means and adapted to contain said at least one follicular unit, (Para. [0054], “In further embodiments, a proximal end of the cannula assembly 110 may be coupled to a vacuum unit (not shown) located within the positioning assembly 106. In such cases, the vacuum unit creates suction within the lumen 217 of the harvesting cannula 200, to thereby pull the target follicular unit 302 away from its underlying tissue as the harvesting cannula 200 is removed from the patient.”)
said at least one suction conduit being interposed between said hollow cannula and said punch; (Para. [0012], “In some embodiments, a vacuum source may be selectively placed in communication with the harvesting cannula lumen to apply a proximally directed “pulling” force to facilitate grasping and extracting the follicular units.”).
Bodduluri’s “vacuum source … selectively placed in communication with the harvesting cannula lumen” is “interposed between said hollow cannula and said punch” by virtue of the relative positions of Bodduluri’s “punch” and “hollow cannula.”
command and image acquisition means associated with said analysis and verification portion for the acquisition of images of contents of said analysis and verification portion, (Fig. 1, “camera(s) 28;” Para. [0055], “In some embodiments, the camera(s) 28 and the computer 120 may be used to determine an amount of the implanting cannula 202 that has been advanced into the patient. For example, the implanting cannula 202 may include a plurality of marker lines for allowing the camera(s) 28 or a physician to “see” how much of the implanting cannula 202 has been inserted into the patient. As shown in the figure, the implanting cannula 202 creates an opening 314 below the patient's skin 314, in which the follicular unit 302 may be placed.”);
said command and image acquisition means being functionally associated with at least one screen defined by an analysis and verification unit external to said handling device for displaying said images on an enlarged scale showing the contents of said analysis and verification portion in such a manner as to examine and verify properties of said at least one follicular unit directly from said analysis and verification portion before its implantation. (Fig. 7, “computer 120” is depicted as having a “screen;” Para. [0055], “In some embodiments, the camera(s) 28 and the computer 120 may be used to determine an amount of the implanting cannula 202 that has been advanced into the patient. For example, the implanting cannula 202 may include a plurality of marker lines for allowing the camera(s) 28 or a physician to “see” how much of the implanting cannula 202 has been inserted into the patient;” Para. [0058]).
The term “for displaying said images on an enlarged scale showing the contents of said analysis and verification portion in such a manner as to examine and verify properties of said at least one follicular unit directly from said analysis and verification portion before its implantation” is being interpreted as an intended use of the recited “screen.” Para. [0058] describes a similar use.
Bodduluri’s “computer 120” is external to Bodduluri’s handling device, as can be seen in Bodduluri’s Fig. 7.
Bodduluri does not disclose:
made of a material transparent to light,
said command and image acquisition means comprising at least one still camera which is configured to frame the contents of said analysis and verification portion,
Knowlton describes “…medical instrumentation and methods applied to the surgical management of burns, skin defects, and hair transplantation” (Para. [0023]). Knowlton is analogous art.
Knowlton teaches:
made of a material transparent to light, (Para. [0517], “In an embodiment, a clear manifold suction cannula is applied directly to the fractionally resected skin surface.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bodduluri with the teachings of Knowlton (i.e., to modify the device of Bodduluri such that its suction conduit is made from a clear material in the manner of Knowlton) because such a modification entails only a simply substitution of one known element for another to obtain predictable results.
The prior art contains a device (i.e., the device of Bodduluri) which differs from the claimed device by the substitution of some components (i.e., Bodduluri’s vacuum unit of an unspecified material) with other components (i.e., a vacuum unit made of a clear material).
The substituted components and their functions were known in the art. For example, Knowlton teaches such clear material at Para. [0517].
One of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable.
Qureshi describes a “System and method for selecting follicular units for harvesting” (Title). Qureshi is analogous art.
Qureshi teaches:
wherein said command and image acquisition means comprise at least one still camera (Para. [0011], “One example of the image acquisition device is one or more cameras, such as any commercially available cameras. Instead of a camera, it could be a video recording device (such as a camcorder) or any other image acquisition device.”);
which is configured to frame the contents of said analysis and verification portion. (Para. [0058], “The camera(s) may have viewfinders such that when attached to the glasses it allows the physician to view exactly what the cameras are imaging.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bodduluri with the teachings of Qureshi (i.e., to use such a still camera as taught by Qureshi in place of Bodduluri’s video camera) because such a modification entails only a simply substitution of one known element for another to obtain predictable results.
The prior art contains a device (i.e., the device of Bodduluri) which differs from the claimed device by the substitution of some components (i.e., Bodduluri’s video camera) with other components (i.e., a still camera).
The substituted components and their functions were known in the art. For example, Qureshi teaches such a still camera at Para. [0011].
One of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bodduluri with the teachings of Qureshi (i.e., to configure Bodduluri’s camera to frame the contents of the analysis and verification portion in the manner of Qureshi) in order to allow the physician to view exactly what the cameras are imaging (Qureshi at Para. [0011]).
Regarding Claim 22, the combination of Bodduluri, Knowlton and Qureshi renders obvious the entirety of Claim 18 as explained above.
Bodduluri additionally discloses:
wherein said incision means comprise a needle of the surgical type (Para. [0028], “The implanting cannula 36 has a needle-like tissue piecing tip, and the harvesting cannula has a tissue-coring (e.g., serrated) tip.”);
configured to move via actuation of said drive means between an inactive position, in which said needle is retracted into said distal section, and an incision position, in which said needle is extracted from said distal section. (Para. [0031], “The tubular sleeve 65 engages a rack-and-pinion drive mechanism 81 driven by a first motor 62 of the motor drive assembly 60, so that, when the hub 34 is coupled to the gripper 63, the motor 62/drive mechanism 81 provide axial (i.e., reciprocating) motion of the implanting cannula 36 relative to the harvesting cannula 38 (and also relative to the tool assembly housing 22/24);” Para. [0037], “With reference to FIGS. 6A-B, the tissue-piercing distal end 37 of the implanting cannula 36 is advanced over the harvesting cannula 38 and into the body surface 68, creating a subcutaneous implantation cavity 70 of an appropriate depth and size for receiving the harvested follicular unit 72. This puncture motion by the cannula 36 is automatically controlled by motor 62, and is preferably very rapid in order to minimize trauma to the tissue surface 74 of the implantation cavity 70.”).
Regarding Claim 23, the combination of Bodduluri, Knowlton and Qureshi renders obvious the entirety of Claim 18 as explained above.
Bodduluri additionally discloses
wherein said needle is configured to be disengaged from said distal section for its easy and immediate substitution (Para. [0031], “In particular, the implanting cannula 36 is fixedly attached to a proximal hub 34, including a distal facing tapered portion 34 a and a proximally directed engagement portion 34 b. The engagement portion 34 b may be detachably-coupled (snap-fit) with a resilient gripper 63 extending from a tubular sleeve 65 in the motor drive assembly 60;” Para. [0028]).
The term “for its easy and immediate substitution” is being interpreted as an intended use. Bodduluri’s “implanting cannula 36” is detachable, and thus “configured to be disengaged” in the manner claimed. Bodduluri’s “implanting cannula 36” is described as a needle at Para. [0028]. Bodduluri’s “implanting cannula 36” is detachable for any purpose, including for the intended use of “for its easy and immediate substitution.”
Regarding Claim 25, the combination of Bodduluri, Knowlton and Qureshi renders obvious the entirety of Claim 24 as explained above.
Bodduluri additionally discloses:
wherein said punch is configured to be disengaged from said distal section for an easy and immediate substitution thereof (Para. [0032], “The elongate body 46 further includes a recessed section 44 located proximally of the flanges 48, which seats an annular retaining member 50 for detachably-coupling (via a snap-fit type connection) with the tubular drive member (proximal of the slots that engage flanges 48), thereby retaining the harvesting cannula 38 in position when the tool 32 is coupled with the motor dive assembly 60;” Para. [0028]).
The term “for an easy and immediate substitution thereof” is being interpreted as an intended use. Bodduluri’s “harvesting cannula 38” is detachable, and thus “configured to be disengaged” in the manner claimed. Bodduluri’s “harvesting cannula 38” is described as having the structure of a punch at Para. [0028]. Bodduluri’s “harvesting cannula 38” is detachable for any purpose, including for the intended use of “for an easy and immediate substitution thereof.”
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2007/0078475 A1 to Bodduluri et al. (“Bodduluri”) in view of previously cited US 2019/0054283 A1 to Knowlton (“Knowlton”) and previously cited US 2009/0306680 A1 to Qureshi et al. (“Qureshi”) as applied to Claim 18 above, and further in view of previously cited US 2014/0343575 A1 to Silvano et al. (“Silvano”).
Regarding Claim 19, the combination of Bodduluri, Knowlton and Qureshi renders obvious the entirety of Claim 18 as explained above.
Bodduluri additionally discloses:
wherein said distal section and said proximal section are mutually associated via a shape coupling connector (Para. [0031], “In particular, the implanting cannula 36 is fixedly attached to a proximal hub 34, including a distal facing tapered portion 34 a and a proximally directed engagement portion 34 b. The engagement portion 34 b may be detachably-coupled (snap-fit) with a resilient gripper 63 extending from a tubular sleeve 65 in the motor drive assembly 60;” Para. [0032], “The elongate body 46 further includes a recessed section 44 located proximally of the flanges 48, which seats an annular retaining member 50 for detachably-coupling (via a snap-fit type connection) with the tubular drive member (proximal of the slots that engage flanges 48), thereby retaining the harvesting cannula 38 in position when the tool 32 is coupled with the motor dive assembly 60.”)
The combination of Bodduluri, Knowlton and Qureshi does not disclose:
of the bayonet type.
Silvano describes “a device for tissues sampling and grafting, such as follicular units, in the operations of hair or skin portions transplant” (Para. [0024]). Silvano is analogous art.
Silvano teaches:
of the bayonet type (Para. [0039], “In a first variant of the preferred embodiment, shown in FIGS. 22 to 24, the device 1 also comprises a fixing element 100, for example shaped as a Luer Lock or bayonet or quick coupling or truncated cone…”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of the combination of Bodduluri, Knowlton and Qureshi with the teachings of Silvano (i.e., to modify the device of the combination of Bodduluri, Knowlton and Qureshi such that Bodduluri’s snap-fit connection mechanism is instead such a bayonet mechanism as taught by Silvano) because such a modification entails only a simply substitution of one known element for another to obtain predictable results.
The prior art contains a device (i.e., the device of Bodduluri) which differs from the claimed device by the substitution of some components (i.e., Bodduluri’s snap-fit connection) with other components (i.e., a bayonet mechanism).
The substituted components and their functions were known in the art. For example, Silvano teaches such a bayonet mechanism at Para. [0039].
One of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable.
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2007/0078475 A1 to Bodduluri et al. (“Bodduluri”) in view of previously cited US 2019/0054283 A1 to Knowlton (“Knowlton”) and previously cited US 2009/0306680 A1 to Qureshi et al. (“Qureshi”) as applied to Claim 18 above, and further in view of previously cited WO 2015/186146 A1 to Pradhan et al. (“Pradhan”).
Regarding Claim 27, the combination of Bodduluri, Knowlton and Qureshi renders obvious the entirety of Claim 18 as explained above.
The combination of Bodduluri, Knowlton and Qureshi does not disclose:
further comprising suction means associated with said explantation and implantation means for at least one operation chosen from suction and thrusting of said at least one follicular unit
Pradhan describes “Hair transplant systems and methods for their use” (Title). Pradhan is analogous art.
Pradhan teaches:
further comprising suction means associated with said explantation and implantation means for at least one operation chosen from suction and thrusting of said at least one follicular unit (Para. [0044], “The main drive unit as shown in FIG. l comprises of at least one set of remote foot control (5); at least one vacutainer (6); a user interface control panel (7); at least one vacuum line tubing (8); at least one antimicrobial filter (9); at least one vacuum pump (10); at least one vacuum regulator (11) and at least one solenoid valve (12); at least one controller unit (13) that drives all peripheral devices; at least one power supply (14);” Para. [0047]).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Bodduluri, Knowlton and Qureshi with the teachings of Pradhan (i.e., to use such a pneumatic drive unit as taught by Pradhan to drive the explantation and implantation means of Bodduluri) in order to “facilitate simultaneous working of extraction and implantation” (Pradhan at Paras. [0010] through [0012]).
Regarding Claim 28, the combination of Bodduluri, Knowlton, Qureshi and Pradhan renders obvious the entirety of Claim 27 as explained above.
Pradhan additionally teaches:
wherein said suction means comprise a solenoid valve associated with said hollow cannula and associable with a suction apparatus; (Para. [0044], “The main drive unit as shown in FIG. l comprises of at least one set of remote foot control (5); at least one vacutainer (6); a user interface control panel (7); at least one vacuum line tubing (8); at least one antimicrobial filter (9); at least one vacuum pump (10); at least one vacuum regulator (11) and at least one solenoid valve (12); at least one controller unit (13) that drives all peripheral devices; at least one power supply (14).”).
The combination of Bodduluri, Knowlton, Qureshi and Pradhan does not disclose:
said solenoid valve being detachably associated with said proximal section via a fixing collar
However, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bodduluri, Knowlton and Pradhan such that its solenoid is “detachably associated” in the manner claimed because such a modification entails only making known components separable, which is a common practice that the court has held normally requires only ordinary skill in the art and is hence considered a routine expedient. See MPEP 2144.04(V)(C).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2007/0078475 A1 to Bodduluri et al. (“Bodduluri”) in view of previously cited US 2019/0054283 A1 to Knowlton (“Knowlton”) and previously cited US 2009/0306680 A1 to Qureshi et al. (“Qureshi”) as applied to Claim 18 above, and further in view of previously cited CN 110393558 A (“CN ‘558”).
Regarding Claim 31, the combination of Bodduluri, Knowlton and Qureshi renders obvious the entirety of Claim 18 as explained above.
The combination of Bodduluri, Knowlton and Qureshi does not disclose:
wherein said at least one still camera is associated with said distal section via a slider provided with a fastening hook which is configured to engage with a fastening screw associated with said at least one still camera for a locking thereof.
CN ‘558 describes “An Illuminated Camera Attraction Retractor Applied in the Transmuscular Space Approach of Lumbar Spine Surgery” (Machine Translation of CN ‘558 at Pg. 1 of 4, “Description” section). CN ‘558 is reasonably pertinent to the problem faced by the inventor, as both pertain to visualizing a surgical field via a camera. CN ‘558 is thus analogous art.
CN ‘558 teaches:
wherein said at least one still camera is associated with said distal section via a slider provided with a fastening hook which is configured to engage with a fastening screw associated with said at least one still camera for a locking thereof. (Abstract).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Bodduluri, Knowlton and Qureshi with the teachings of CN ‘558 (i.e., to associate the camera of combined Bodduluri, Knowlton and Qureshi with such a slider provided with a fastening hook as taught by CN ‘558) because such a modification entails only a simply substitution of one known element for another to obtain predictable results.
The prior art contains a device (i.e., the device of Bodduluri) which differs from the claimed device by the substitution of some components (i.e., Bodduluri’s unspecified camera fixation means) with other components (i.e., camera fixation via a slider provided with a fastening hook).
The substituted components and their functions were known in the art. For example, CN ‘558 teaches such camera fixation via a slider provided with a fastening hook at its Abstract.
One of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2007/0078475 A1 to Bodduluri et al. (“Bodduluri”) in view of previously cited US 2019/0054283 A1 to Knowlton (“Knowlton”) and previously cited US 2009/0306680 A1 to Qureshi et al. (“Qureshi”) as applied to Claim 18 above, and further in view of previously cited CN 106618647 A (“CN ‘647”).
Regaring Claim 34, the combination of Bodduluri, Knowlton and Qureshi renders obvious the entirety of Claim 18 as explained above.
The combination of Bodduluri, Knowlton and Qureshi does not disclose:
wherein said drive means comprise micro-motors of the brushless type
CN ‘647 describes a “Hair follicle extracting and planting integrated instrument” (Title). CN ‘647 is analogous art.
CN ‘647 teaches:
wherein said drive means comprise micro-motors of the brushless type (Machine Translation of CN ‘647 at Pg. 2 of 7, Para. 7, “Further, the first motor is a stepping motor, and the second motor is a DC brushless motor. The stepper motor can change the up and down moving distance of the cutter head by changing the number of rotation circles. The brushless DC motor has good stability, more precise control, and better controllability than ordinary motors. It can realize frequency conversion control and easy speed adjustment.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bodduluri, Knowlton and Qureshi with the teachings of CN ‘647 (i.e., to employ such a brushless motor as taught by CN ‘647 in the drive unit of Bodduluri) in order to impart “good stability, more precise control, and better controllability” and “realize frequency conversion control and easy speed adjustment” (Machine Translation of CN ‘647 at Pg. 2 of 7, Para. 7).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.J.M./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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