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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/15/2025 has been entered.
Response to Amendment
The Amendment filed 12/15/2025 has been entered. Claims 1 and 8-26 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejections previously set forth in the Final Office Action mailed 10/14/2025. New grounds of rejections necessitated by amendments are discussed below.
Claim Objections
Claim 1 is objected to because of the following informalities: In lines 24-25, the phrase “and then for each subsequent unit of the plurality movable units, the control part is configured withdrawal movement of the respective unit…” (emphasis added) appears to have missing words or grammatical mistakes. It is suggested to recite “the plurality movable units” as “the plurality of movable units”. 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:
“control part” in claim 1;
“drive unit” in claim 16; and
“suction pressure part” in claim 21.
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.
In this case, “control part” in claim 1 is being interpreted as a control circuit (specification, paragraph [0062]) and equivalents thereof;
“drive unit” in claim 16 is being interpreted as a motor (paragraph [0059]) and equivalents thereof; and
“suction pressure part” in claim 21 is being interpreted as a syringe or pump (paragraph [0061]) and equivalents thereof.
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.
Claims 1 and 8-26 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.
Regarding claim 1, claim 1 recites the new limitation of “the control part is configured to initiate first movement of a last unit of the plurality of movable units to withdraw the last unit from the living organism and then for each subsequent unit of the plurality movable units, the control part is configured withdrawal movement of the respective unit to withdraw the respective unit from the living organism at a time when a preceding adjacent unit of the plurality of movable units completes withdrawal movement from the living organism” (emphasis added). While the specification (paragraphs [0084]-[0085],[0094]-[0095]) and Figs. 16-20 discloses a withdrawal procedure of each movable unit, the disclosure fails to describe initiating “first movement of a last unit of the plurality of movable units to withdraw the last unit from the living organism”. From the specification (paragraphs [0084]-[0085],[0094]-[0095]) and Figs. 16-20, it appears that a second movement (withdrawal movement) of the first unit 10a to withdraw the first unit is initiated first, and then for each subsequent unit, a withdrawal movement is performed for an adjacent unit from the living organism at a time when a preceding adjacent unit of the plurality of movable units completes withdrawal movement from the living organism. Fig. 7 shows a first unit 10a as the first to penetrate the tissue and Fig. 16 shows the first unit 10a being the first to be withdrew. Therefore, the disclosure fails to disclose: “the control part is configured to initiate first movement of a last unit of the plurality of movable units to withdraw the last unit from the living organism and then…” Claims 8-26 are rejected by virtue of their dependency on claim 1.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 8-26 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 1, claim 1 recites the limitation "the control unit" in line 14. There is insufficient antecedent basis for this limitation in the claim. Note that line 18-19 also recites “control unit”. It is suggested to recite “the control unit” as “the control part” if referring to “a control part” of line 9. For examination purposes, “the control unit” is interpreted as the “control part”. Claims 8-26 are rejected by virtue of their dependency on claim 1.
Regarding claim 26, claim 26 recites the limitation "the flow passage" in line 26. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 8, 12-20, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Merchant et al. (US 20130197427 A1; cited in the IDS filed 08/04/2023) in view of Shiao (US 5417683 A).
Regarding claim 1, Merchant teaches a transfer device (Figs. 4A-4C, fluid injection device) for a living organism for placing an object into the living organism (interpreted as an intended use, see MPEP 2114; Figs. 4A-4C teaches a fluid injection device comprising fluid pathways 212 and needles 218, which are structurally capable of being used for a living organism, e.g. patient, for placing an object, e.g. fluid, in a living organism, e.g. patient; paragraph [0030] teaches fluid or solution is injected into tissue; paragraph [0103] teaches the needle array is selected for tissue and patient comfort, therefore is for a living organism), comprising:
a plurality of movable units (Fig. 4C, needle deployment mechanisms 216 and associated needles 218; paragraph [0099] teaches deploying individual needles at selected depths, i.e. movable units),
each movable unit of the plurality of movable units comprising one needle extending in a first direction (Fig. 4C teaches each needle deployment mechanisms 216 comprises a needle 218 extending in a vertical direction), each needle storing the object therein (Fig. 4C teaches each needle 218 with a volume; paragraphs [0030],[0171] teach needles having a solution, therefore includes an object),
each movable unit of the plurality of movable units being configured to move in the first direction (Fig. 4C and paragraph [0099] teaches deploying individual needles at selected depths, i.e. moves in a vertical direction), and
a control part (Fig. 4C, fluid injection control unit 210) that that independently controls movement of each of the plurality of movable units in the first direction (paragraph [0099] teaches the injection control unit selects the injection depth of each needle; paragraphs [0083] and [0101] teaches the control unit provides a signal to control the deployment or retraction of the needles),
wherein the control unit is configured to consequently move each of the plurality of movable units towards the living organism so that the needle of each of the plurality of movable units penetrate the living organism (paragraph [0083] teaches the control unit deploys the needles one at a time; paragraph [0101] teaches the control unit provides a signal to control the deployment of the needles to penetrate tissue; therefore, the control unit is configured to consequently move each needle of the movable units to penetrate the living organism),
the control part is configured to initiate first movement of a first unit of the plurality of movable units and then for each subsequent unit of the plurality of movable units, the control unit is configured to initiate movement of a respective unit (paragraph [0082] teaches controlling the depth to which the needle array is deployed; paragraph [0083] teaches the control unit deploys the needles one at a time; paragraph [0101] teaches the control unit provides a signal to control the deployment of the needles to penetrate tissue);
the control part is configured to consequently withdraw each of the plurality of movable units from the living organism (paragraph [0083] teaches the control unit retracts the needle one at a time); the control part is configured to initiate first movement of a last unit of the plurality of movable units to withdraw the last unit from the living organism (paragraph [0083] teaches the control unit retracts the needle one at a time).
While Merchant teaches an embodiment of a needle as a tubular member having a lumen (paragraph [0105]), Merchant fails to explicitly teach: each movable unit comprising at least two identical needles; each needle having a cylindrical shape storing the object therein (as shown the embodiment of Fig. 4C); and wherein the control unit is configured to consequently move each of the plurality of movable units towards the living organism so that each of the needles of each of the plurality of movable units penetrate the living organism for the same penetration depth, the control unit is further configured to release the object into the living organism after the needles of each of the plurality of movable units penetrate the living organism for the same penetration depth, the control unit is configured to initiate movement of the respective unit at a time when the movement of a preceding adjacent unit stops after penetrating to said penetrating depth; and then for each subsequent unit of the plurality movable units, the control part is configured withdrawal movement of the respective unit to withdraw the respective unit from the living organism at a time when a preceding adjacent unit of the plurality of movable units completes withdrawal movement from the living organism.
Shiao teaches a mini-graft hair implantation device for implanting multiple clumps of hair follicles at one time (abstract). Shiao teaches the device comprises a barrel that has a cluster of one to ten identical hollow needles that are movable and cylindrical (column 3, lines 6-10; Figs. 1-9). Shiao teaches with this device, implanting hair follicles is no longer manually done in a one-by-one matter, and instead multiple clumps can be implemented at the same time with the depth of the hair implant precisely controlled; thus, saving time and effort, minimize damage to the hair follicles and increases viability (column 2, lines 35-44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified each of the movable units of Merchant to incorporate the teachings of at least two identical cylindrical needles as a movable unit for hair transplantation of Shiao (Figs. 1-6; column 3, lines 6-10; Figs. 1-9) to provide: each movable unit comprising at least two identical needles; each needle having a cylindrical shape storing the object therein. Doing so would have a reasonable expectation of successfully improving time and effort of injection and penetration of multiple needles and objects as discussed by Shiao (column 2, lines 35-44). Additionally doing so would have utilized known shapes for needles with a reasonable expectation of successfully improving injection into tissue. Additionally, doing so would have been an obvious change in shape, wherein a cylindrical shaped needle is a matter of choice which a person of ordinary skill in the art would have found obvious (MPEP 2144.04 (IV)(B)).
Modified Merchant fails to explicitly teach: wherein the control unit is configured to consequently move each of the plurality of movable units towards the living organism so that each of the needles of each of the plurality of movable units penetrate the living organism for the same penetration depth, the control unit is further configured to release the object into the living organism after the needles of each of the plurality of movable units penetrate the living organism for the same penetration depth, the control unit is configured to initiate movement of the respective unit at a time when the movement of a preceding adjacent unit stops after penetrating to said penetrating depth; and then for each subsequent unit of the plurality movable units, the control part is configured withdrawal movement of the respective unit to withdraw the respective unit from the living organism at a time when a preceding adjacent unit of the plurality of movable units completes withdrawal movement from the living organism.
Merchant further teaches wherein the control part is configured to move the movable units toward the living organism to allow the needles to penetrate the living organism (paragraph [0101] teaches the control unit provides a signal to control the deployment of the needles to penetrate tissue; therefore, is configured to move the needles towards and to penetrate a tissue of a patient; paragraph [0030] teaches fluid or solution is injected into tissue; paragraph [0083] teaches the control unit deploys the needles; paragraph [0103] teaches the needle array is selected for tissue and patient comfort). Merchant teaches the control unit controls individual deployment and retraction of one or more needles, such as deploying or retracting the needles one at a time (paragraph [0083]); and a situation where the needles are all retracted (Fig. 8A) and a situation where the needles are all withdrawn (Fig. 8B). Merchant teaches delivering solution sequentially to groups of one or more needles, or to individually deployed needles (paragraph [0088]). Merchant teaches deploying the needles at a predetermined depth (paragraph [0090]), such as a single injection depth (paragraph [0102]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control part of modified Merchant to incorporate the teachings of deploying and withdrawing needles individually and one at a time, sequentially delivering solutions to each needle, and deploying individual needles at a single injection depth of Merchant (paragraphs [0083], [0088],[0090], [0099], [0102]) to provide: wherein the control unit is configured to consequently move each of the plurality of movable units towards the living organism so that each of the needles of each of the plurality of movable units penetrate the living organism for the same penetration depth, the control unit is further configured to release the object into the living organism after the needles of each of the plurality of movable units penetrate the living organism for the same penetration depth, the control unit is configured to initiate movement of the respective unit at a time when the movement of a preceding adjacent unit stops after penetrating to said penetrating depth; and then for each subsequent unit of the plurality movable units, the control part is configured withdrawal movement of the respective unit to withdraw the respective unit from the living organism at a time when a preceding adjacent unit of the plurality of movable units completes withdrawal movement from the living organism. Doing so would have a reasonable expectation of successfully improving automation and control of movement of each movable unit at a desired injection depth and ensuring that each movable unit penetrates the tissue one at a time at the desired depth and is withdrawn one at a time after the movable units released the object into the living organism (Merchant, paragraphs [0083, [0088],[0090], [0099], [0102]).
Regarding claim 8, Merchant further teaches wherein the control part is configured to move each movable unit of the plurality of movable units to continuously perform (paragraphs [0082]-[0084],[0087]-[0088] teaches the control unit controls deployment of needles, delivery of solution, and retraction of needles, therefore is configured to control each needle to continuously perform the steps) the penetration of the needles into the living organism (paragraph [0101] teaches the control unit provides a signal to control the deployment of the needles to penetrate tissue; therefore, is configured to move the needles towards and to penetrate a tissue of a patient; paragraph [0030] teaches fluid or solution is injected into tissue; paragraph [0083] teaches the control unit deploys the needles), the release of the object accommodated in the needles from the needles (paragraph [0087] teaches a flow control device controlled by the control unit 210; paragraph [0088] teaches deploying the needles and then delivering the solution to the needles; paragraph [0101] teaches the control unit synchronizes the deployment mechanism with the injection of solution, i.e. object, into the tissue), and the withdrawal of the needles from the living organism (paragraph [0083] teaches the control unit 210 controls retraction of the needles, i.e. a direction away from a living organism to withdraw needles).
Regarding claim 12, Merchant further teaches wherein the plurality of movable units are arranged linearly (Figs. 4C and 5 teach needles 218 are arranged linearly).
Regarding claim 13, modified Merchant fails to explicitly teach: wherein each movable unit of the plurality of movable units comprises two or more and ten or less identical needles extending in the first direction.
Shiao teaches a mini-graft hair implantation device for implanting multiple clumps of hair follicles at one time (abstract). Shiao teaches the device comprises a barrel that has a cluster of one to ten identical hollow needles that are movable (column 3, lines 6-10; Figs. 1-6). Shiao teaches with this device, implanting hair follicles is no longer manually done in a one-by-one matter, and instead multiple clumps can be implemented at the same time with the depth of the hair implant precisely controlled; thus, saving time and effort, minimize damage to the hair follicles and increases viability (column 2, lines 35-44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified each of the movable units of modified Merchant to incorporate the teachings a plurality of needles, such as one to ten identical hollow needles, as a movable unit for hair transplantation of Shiao (Figs. 1-6; column 3, lines 6-10; Figs. 1-6) to provide: wherein each movable unit of the plurality of movable units comprises two or more and ten or less identical needles extending in the first direction. Doing so would have a reasonable expectation of successfully improving time and effort of injection and penetration of multiple needles and objects as discussed by Shiao (column 2, lines 35-44).
Regarding claim 14, Merchant further teaches wherein the plurality of movable units comprise at least six movable units (Fig. 4A-4C teaches at least six movable units with needles 218).
Regarding claim 15, modified Merchant further teaches wherein the at least two needles are the only objects extending from each movable unit of the plurality of movable units in the first direction (see above claim 1; Merchant in view of Shiao teaches each movable unit comprising at least two identical needles, therefore the at least two needles are the only objects extending from each movable unit of the plurality of movable units in the first direction).
Regarding claim 16, Merchant further teaches the transfer device of claim 1, wherein further comprising a drive unit moving each movable unit of the plurality of movable units along the first direction (Figs. 4A-4C and paragraph [0020] teaches the needle deployment mechanism includes at least one electric motor; paragraph [0083] teaches individual deployment of needles one at a time; therefore, the device includes a motor for each movable unit to deploy each needle).
Regarding claim 17, Merchant further teaches the transfer device of claim 16, further comprising an outer peripheral part surrounding the plurality of movable units (Figs. 4A-4C, element 214), wherein the drive unit moves each movable unit of the plurality of movable units between a first position in which tip parts of the at least two identical needles do not protrude more than a tip part of the outer peripheral part, and a position in which the tip parts of the at least two identical needles protrude more than the tip part of the outer peripheral part in the first direction (Figs. 4A-4C and paragraph [0020] teaches the needle deployment mechanism includes at least one electric motor; paragraph [0083] teaches individual deployment of needles one at a time; Fig. 4C shows an example of the right movable unit at a first position in which the tip does not protrude more than a tip part of element 214, and the left movable unit at a position where the tip part of the needle protrudes more than a tip part of element 214; see above claim 1; Merchant in view of Shiao teaches each movable unit comprising at least two identical needles, therefore the drive unit is capable of moving the needles as claimed).
Regarding claim 18, Merchant further teaches wherein each movable unit of the plurality of movable units further comprises a support part supporting the at least two identical needles (see above claim 1; Merchant in view of Shiao teaches each movable unit comprising at least two identical needles; Fig. 4C shows a support part 216 for each unit that supports the needles 218; therefore, the movable units comprise support parts supporting the two needles).
Regarding claim 19, modified Merchant fails to teach: wherein a tip part of each of the at least two identical needles is truncated obliquely relative to the first direction.
Shiao teaches a tip part of each of the at least two identical needles is truncated obliquely relative to the first direction (Figs. 1-3 shows the tip part of each needle 120 is truncated obliquely).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least two identical needles to provide: wherein a tip part of each of the at least two identical needles is truncated obliquely relative to the first direction. Doing so would have a reasonable expectation of successfully improving the ability of the needles to penetrate the living organism.
Regarding claim 20, Merchant further teaches wherein the drive unit includes an electrical a motor (Figs. 4A-4C and paragraph [0020] teaches the needle deployment mechanism includes at least one electric motor), and moves each movable unit of the plurality of movable units independently depending on a control signal from the control part (Figs. 4A-4C and paragraph [0020] teaches the needle deployment mechanism includes at least one electric motor; paragraph [0083] teaches the control unit controls individual deployment of needles one at a time).
Regarding claim 25, modified Merchant further teaches wherein each of the at least two identical needles (see above claim 1; Merchant in view of Shiao teaches each movable unit comprising at least two identical needles of Merchant, wherein Merchant teaches the structure of one needle as shown in Figs. 4A) comprises a first tube including a tip part of the needle (Fig. 4A and paragraph [0105], interpreted as the conical tube shaped tip part of needle 218), and a second tube having a larger flow passage cross-sectional area than that of the first tube (Fig. 4A, interpreted as the tube portion between elements 212 and 218 that has a larger cross-sectional area than the conical tube shaped tip of needle 218), an internal space of the first tube and the internal space of the second tube communicate with each other and form a single flow passage of the needle (Fig. 4A).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Merchant in view of Shiao as applied to claim 1 above, and further in view of Takada et al. (US 20170014608 A1).
Regarding claim 9, modified Merchant fails to explicitly teach: wherein a sum of the needles provided in the plurality of movable units is 5 or more (the embodiment of Fig. 4C shows two needles 218), and the needles are arranged at a density of 5 or more per cm2.
Merchant teaches embodiments of 5 or more needles (Figs. 1-3, 4A-4B, 5, 7-9). Merchant teaches control individual depths of needles (paragraph [0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the needles of modified Merchant to incorporate the teachings of 5 or more needles of Merchant (Figs. 1-3, 4A-4B, 5, 7-9) to provide: wherein a sum of the needles provided in the plurality of movable units is 5 or more. Doing so would have a reasonable expectation of successfully improving injection and control of injection of the desired object into a living organism as taught by Merchant (paragraph [0099]).
While Merchant teaches it may desirable to have a denser needle spacing (paragraph [0104]) and an embodiment comprising micro-needles (paragraph [0103]), modified Merchant fails to teach: the needles are arranged at a density of 5 or more per cm2.
Takada teaches a microneedle preparation administration apparatus (abstract) comprising a plurality of microneedles (Fig. 7). Takada teaches the microneedle preparations exist on the platform in a density from 30 to 300 needles/cm^2 (paragraph [0097]). Takada teaches the density of the microneedle preparation affects the dosage amount of the substance (paragraph [0097]).
Since Takada teaches a plurality of microneedle, similar to modified Merchant, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the needles of modified Merchant to incorporate the teachings of microneedle densities of greater than 5 per cm2 of Takada (paragraph [0097]) and the teachings of embodiments of 5 or more needles of Merchant (Figs. 1-3, 4A-4B, 5, 7-9) and the desirability of having a denser needle spacing of Merchant (paragraph [0104]) to provide: the needles are arranged at a density of 5 or more per cm2. Doing so would have a reasonable expectation of successfully improving the density of needles and thus improving the injection amount into a desired area of the desired object (Takada, paragraph [0097]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Merchant in view of Shiao as applied to claim 1 above, and further in view of Bodduluri et al. (US 20070106306 A1).
Regarding claim 10, while Merchant teaches injection of a solution into tissue (paragraph [0060]), modified Merchant fails to teach wherein the object is a cell aggregate containing skin-derived stem cells.
Bodduluri teaches an automated system for harvesting or implanting follicular units (abstract) comprising harvesting and implantation of hair follicles from/in a human scalp (paragraph [0047]). Bodduluri teaches one or more hair follicle harvesting and/or implantation needles (paragraph [0074]). Bodduluri teaches a needle harvesting a respective follicular section containing a sufficient quantity of follicular epithelial stem cells and the structural matrix of the collagenous sheath from a patient’s scalp (paragraph [0117]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the object of modified Merchant to incorporate the teachings of harvesting and implantation of follicular epithelial stem cells from a patient’s scalp for hair transplantation of Bodduluri (paragraph [0117]) to provide: wherein the object is a cell aggregate containing skin-derived stem cells. Doing so would have a reasonable expectation of successfully improving injection of desired cells into tissue, such as by utilizing known stem cells as taught by Bodduluri (paragraph [0117]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Merchant in view of Shiao as applied to claim 1 above, and further in view of Rosengart et al. (US 5846225 A).
Regarding claim 11, modified Merchant fails to teach wherein the plurality of movable units are arranged in a two-dimensional square or hexagonal lattice shape.
Rosengart teaches a gene transfer delivery apparatus including a plurality of syringes, i.e. needles, configured to penetrate tissue to deliver injection of a fixed volume of fluid at plural locations at a predetermined depth (abstract; Figs. 14A-14C). Rosengart teaches delivery device 10 may have a square, rather than a circular cross section, and syringes 62 may be set up on a grid of, for example, nine syringes in a square pattern (column 6, lines 48-54). Rosengart teaches an embodiment where the syringes are configured in a circular pattern (column 6, lines 57-59).
Since Rosengart teaches circular and square patterns of needles are known alternatives in the art (column 6, lines 48-59), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of movable units of modified Merchant to incorporate the teachings of known arrangements of needles of Rosengart (column 6, lines 48-54) to provide: wherein the plurality of movable units are arranged in a two-dimensional square or hexagonal lattice shape. I.e. It would have been obvious to have substituted one known element (Merchant’s linear arrangement of needles) for another (Rosengart’s square pattern of needles), and the results of the substitution would have been predictable (allowing for penetration of a tissue in a desired pattern). See MPEP 2143(I)(B).
Claims 21-24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Merchant in view of Shiao as applied to claim 1 above, and further in view of Carpenter et al. (US 20030069543 A1).
Regarding claim 21, modified Merchant fails to teach the transfer device of claim 1, further comprising a suction pressure part applying suction to an inside space of each of the two or more identical needle to incorporate the object into the respective needle and pressurizing the inside space of the respective needle to release the object from the respective needle.
Carpenter teaches systems containing a sterile container for aspiration, filtering, treating, and reinjection into a subject (abstract), wherein the systems include devices for injection of a therapeutic agent into the surface of a living being (paragraph [0004]). Carpenter teaches there is a need in the art for a sterile closed system aspiration/injection unit for bedside use that can be used to aspirate bone marrow fluids, treat the fluids in a sterile environment, and reinject the treated bone marrow aspirate into a subject in need of bone marrow treatment (abstract). Carpenter teaches the system includes a pressure actuator that provides adjustable pressure so that the volume of fluids drawn into or ejected from the sterile container can be exactly controlled even when the volumes are as small as microliters (paragraph [0102]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the transfer device of modified Merchant to incorporate the teachings of aspiration, filtering, treating, and injection of a therapeutic agent into a living being using a pressure actuator for drawing fluids into or ejecting fluids of Carpenter (abstract; paragraphs [0004],[0102]) to provide: the transfer device of claim 1, further comprising a suction pressure part applying suction to an inside space of each of the two or more identical needle to incorporate the object into the respective needle and pressurizing the inside space of the respective needle to release the object from the respective needle. Doing so would have a reasonable expectation of successfully improving the control and versatility of the transfer device by allowing for both drawing and ejecting fluids from the needle.
Regarding claim 22, modified Merchant fails to teach wherein the suction pressure part performs said applying and said pressurizing in response to a control signal from the control part.
Merchant teaches a fluid injection control unit controlling the amount of fluid injected into tissue (paragraphs [0082]-[0084]).
Carpenter teaches the system includes a pressure actuator that provides adjustable pressure so that the volume of fluids drawn into or ejected from the sterile container can be exactly controlled even when the volumes are as small as microliters (paragraph [0102]). Carpenter teaches a precision motion controller motor that allows for controlled amounts of fluid to be expelled (paragraph [0125]) and a computer system in communication with the motor (paragraph [0127]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the suction pressure part of modified Merchant to incorporate the teachings of controlling injection of fluid of Merchant and precision control of drawing or ejection of fluid of Carpenter provide: wherein the suction pressure part performs said applying and said pressurizing in response to a control signal from the control part. Doing so would have a reasonable expectation of successfully improving control and automation of the suction pressure part.
Regarding claim 23, modified Merchant fails to teach wherein the suction pressure part performs said applying and said pressurizing separately for each movable unit of said plurality of movable units.
Merchant teaches individual deployment, retraction, and control of solution of each needle (paragraphs [0083]-[0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the suction pressure part of modified Merchant to incorporate the teachings of individual control of each needle of Merchant (paragraphs [0083]-[0084]) to provide: wherein the suction pressure part performs said applying and said pressurizing collectively for plurality of movable units. Doing so would have a reasonable expectation of successfully improving control and automation of the suction pressure part.
Regarding claim 24, modified Merchant fails to teach wherein the suction pressure part performs said applying and said pressurizing collectively for plurality of movable units.
Merchant teaches individual deployment, retraction, and control of solution of each needle (paragraphs [0083]-[0084]). Merchant teaches delivery of solution to groups of needles (paragraph [0088]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the suction pressure part of modified Merchant to incorporate the teachings of individual control of each needle and groups of needles of Merchant (paragraphs [0083]-[0084],[0088]) to provide: wherein the suction pressure part performs said applying and said pressurizing collectively for plurality of movable units. Doing so would have a reasonable expectation of successfully improving control and automation of the suction pressure part.
Regarding claim 26, modified Merchant fails to teach: wherein each of the at least two identical needles further comprises a stopper at a junction between the first tube and the second tube, the stopper crosses the flow passage in the needle in a middle of the flow passage.
Merchant teaches a filter may be provided to ensure bubbles are not injected into the tissue (paragraph [0063]).
Carpenter teaches systems containing a sterile container for aspiration, filtering, treating, and reinjection into a subject (abstract). Carpenter teaches the filter, i.e. stopper, allows for filtering fluids before injection into a subject; and liquids can be maintained in sterile conditions (paragraph [0118]). Carpenter teaches a filter (Fig. 4A, element 95) is at a junction between a first tube (72,82) and a second tube (100), where the filter crosses a flow passage of the system in the middle of the flow passage (Fig. 4A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the needles of modified Merchant to incorporate the teachings of a filter of Merchant (paragraph [0063]) and the teachings of a filter in a between a flow passage of different tube elements of Carpenter (Fig. 4A) to provide: wherein each of the at least two identical needles further comprises a stopper at a junction between the first tube and the second tube, the stopper crosses the flow passage in the needle in a middle of the flow passage. Doing so would have a reasonable expectation of successfully improving filtering of undesired elements and ensuring sterile conditions.
Response to Arguments
Applicant’s arguments, see page 4, filed 12/15/2025, with respect to the claim objections and rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive. The claim objections and rejections under 35 U.S.C. 112(b) of 10/14/2025 have been withdrawn.
Applicant’s arguments, see pages 6-8, filed 12/15/2025, with respect to the rejection(s) of the claims under 35 U.S.C. 103, specifically regarding amended claim 1, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of: Merchant et al. (US 20130197427 A1; cited in the IDS filed 08/04/2023) in view of Shiao (US 5417683 A).
Conclusion
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758