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 Amendment
The amendment filed 10/17/25 has been entered. Claims 1, 6-8, 11 have been amended. Claims 2-5, 10, and 12-15 are in the original/ previously presented form. Claim 9 is cancelled. Claim 16 is newly presented. Thus, claims 1-8 and 10-16 remain pending in the application. Applicant’s amendments to the Abstract and Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 07/17/25.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The medicine “is supplied via suction” as in the currently amended claim 11 is not described (see 112a new matter and 112b rejections below).
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function.
Such claim limitation(s) is/are:
“the locking unit” in claim 1. Claim 1 recites a locking unit with either a hook or hook recess (see lines 8-11), “and the hook unlocks from the hook recess to unlock the shaft in response to the shaft moving away from the skin.” (see lines 11-12). Therefore, claim 1 fails to meet the 3-prong test in at least Prong C because Claim 1 modifies the generic placeholder “unit” with sufficient structure for performing the locking and unlocking function. Therefore, due to the amendment, claim 1 will no longer be interpreted under 112f.
“the locking unit” in claim 2. Claim 2 recites the locking unit depending from claim 1, but fails to meet the 3-prong test in at least Prong C because Claim 2 modifies the generic placeholder “unit” with sufficient structure for performing the locking and unlocking function. Therefore, claim 2 will not be interpreted under 112f.
“a locking unit” in claim 16. Claim 16 recites a locking unit with “the locking unit and the shaft defining a coupling including a hook recess and hook”. Therefore, claim 16 fails to meet the 3-prong test in at least Prong C because Claim 16 modifies the generic placeholder “unit” with sufficient structure for performing the locking and unlocking function. Therefore, claim 16 will not be interpreted under 112f.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 11 is 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.
The amendment to claim 11 in lines 4-6 recite “wherein a negative pressure is formed in the second space such that the medicine is supplied via suction when the needle is inserted into the skin”. However, there does not appear to be any support in the drawings or specification for this amended limitation. In Applicant remarks, applicant notes [0099-0101] for support for the claim amendments. These paragraphs support the amendment to claim 1 but do not relate to the medicine supply function. The only mentioning of suction is in [0024]: “the medicine is suctioned from the medicine supply passage when the needle is inserted into the skin” and [0068] “the medicine may be suctioned from a medicine supply passage (not illustrated) when the needle 636 is inserted into the skin”. However, these paragraphs do not support medicine being supplied via suction as in the newly amended limitation. Therefore, because there does not appear to be a figure or paragraph from the original disclosure to support this amended claim limitation, new matter has been introduced that affects the scope of the claims (see MPEP § 608.04(a): new matter rejections should be made when the scope of the claim is modified by the amendment).
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 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 11, lines 4-6 recite “wherein a negative pressure is formed in the second space such that the medicine is supplied via suction when the needle is inserted into the skin”. However, in view of Applicant disclosure, it is unclear to the examiner how the medicine is supplied via suction. In fact, Applicant disclosure and claims describe medicine being supplied/ injected due to a positive pressure (see [0024], [0068], and lines 7-8 of claim 11), which would be the opposite of suction as described in Applicant’s disclosure. However, there does appear to be support for some kind of suctioning of the medication (see [0024] and [0068]).
Therefore, for purposes of examination and to best align with Applicant disclosure, the examiner interprets claim 11 lines 4-6 to read “wherein a negative pressure is formed in the second space such that the medicine is [[supplied via suction]] suctioned when the needle is inserted into the skin”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6-7, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Gilbert (U.S. PGPUB No. 2004/0024367) in view of Pedersen et al. (U.S. PGPUB No. 2013/0211330), hereinafter Pedersen.
Regarding claim 1, Gilbert discloses a medicine injection tip (see [0003]: medicine injection performed with the device) comprising:
a cylinder (5, see FIGURE 1);
a shaft (53) provided in the cylinder (5) and movable in a direction toward or away from skin (see [0019]: 53 moves distally towards needle 22 and “tissue”==skin of desired subject where needle 22 is inserted as seen in the progression from FIGURE 1 to FIGURE 4. 53 “closer to” skin adjacent the needle 22 in FIGURE 4 compared to FIGURE 1 and therefore 53 has moved toward skin from FIGURE 1 to 4);
a needle unit (24 contains needle 22, see [0016]) disposed between (see ‘Modified FIGURE 1 below—Needle unit 24 sandwiched between skin and shaft)
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the shaft (53) and the skin (see [0019]: tissue in which needle 22 is inserted); and
a locking unit (43, see [0024]: 43 comprises deflectable arms) provided between (see ‘Modified FIGURE 1’ above. Locking unit 43 located such that it is sandwiched between the shaft 53 and needle unit 24) the shaft (53) and the needle unit (24) and configured to lock or unlock the shaft (53) as the shaft (53) is moved (see [0023]: 43 couples with 53 and is designed to decouple after the syringe piston has reached distal end 29 of the syringe. Decoupling/ unlocking shown in FIGUREs 5-6. Locking shown in FIGUREs 1-4),
wherein a hook recess (see where hook 46 is coupled to shaft at a radially recessed position relative the cylinder in ‘Modified FIGURE 1’ above. See coupling description in [0023-0024]) is provided in any one of the shaft (53) and the locking unit, and
wherein a hook (see [0024]: 43 comprises deflectable arms 46 and therefore a ‘hook’ formed of the inside surface of the arm) operable to be locked to or unlocked from the hook recess (see [0023-0024]: coupling/ locking of 46 with hook recess of shaft 53 shown in FIGURES 1-4. Decoupling/ unlocking as described in [0023-0024] is initiated in FIGURE 5 and complete in FIGURE6) is provided in the other of the shaft and the locking unit (43), and the hook (hook formed on inside surface of arm 46) unlocks from the hook recess (where hook 46 is coupled to shaft at a radially recessed position relative the cylinder in ‘Modified FIGURE 1’ above) to unlock the shaft (53, see [0023-0024]: decoupling locking unit from shaft by way of hook and hook recess decoupling).
Gilbert further discloses that the shaft (53) and the locking unit mechanism (43 coupled to shaft 53 and couples/decouples as in [0023-0024]) can be of any configuration that enables decoupling between the shaft and locking unit after a desired dose of medicament is delivered (see [0019-0020]).
Gilbert is silent to the hook unlocks from the hook recess to unlock the shaft “in response to the shaft moving away from the skin.”
However, Pedersen teaches a medicine injection tip comprising a shaft (760, see Fig. 13a); a needle unit (see ‘Modified FIG. 13a’ below);
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and a locking unit (710 including bores 715/716, see ‘Modified FIG. 13a’ above and [0123]) provided between the shaft (760) and the needle unit (see ‘Modified FIG. 13a’ above) and configured to lock or unlock the shaft as the shaft is moved (see [0122-0123]), wherein a hook recess (recess of bore 716, see [0123]) is provided in any one of the shaft and the locking unit (710), and wherein a hook (716) operable to be locked to or unlocked from (as shown in FIG. 13a and described in [0123]) the hook recess (recess of bore 716) is provided in the other of the shaft (hook 761 on shaft 760, see [0120] & [0122]) and the locking unit, and the hook (761) unlocks from (see progression of middle figure in Fig.13a to rightward figure) the hook recess (recess of bore 716) to unlock the shaft (760) in response to the shaft moving away from the skin (shaft moves proximally as shown by arrow in ‘Modified FIG. 13a’ above and described in [0123]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hook mechanism between the shaft and locking unit disclosed in Gilbert to unlock the hook and hook recess in response to the shaft moving away from the skin as taught by Pedersen for the purpose of allowing the coupling to act as a damper to initially slow down the speed of the plunger while ensuring that the shaft and coupling do not dampen the injection speed during medication delivery (see [0122-0125]), which would be beneficial to Gilbert that has the shaft in a distal position after decoupling, thus achieving the hook unlocks from the hook recess to unlock the shaft “in response to the shaft moving away from the skin.”
Regarding claim 2, the modified system of Gilbert teaches the medicine injection tip of claim 1, and Gilbert further discloses wherein the locking unit (43, see ‘Modified FIG. 1’ above) comprises:
a locking bracket (47, see ‘Modified FIG. 1’ above where arms 46 of locking unit 43 meet the plunger, see also [0023-0024]) being coaxial (see FIG. 1) with the shaft (53) and connected to (see [0022]: plunger 40 sealed with plunger 41 retained in needle unit 24 and see [0023-0024]: plunger 40 forms locking unit 43 with arms 46) the needle unit (24); and
a locking arm (46) elastically supported by (see [0024]: deflectable arms 46 affixed to plunger 40 at locking bracket 47. Thus, connection at the locking bracket supports the locking arms 46 while the load from the shaft 53 is applied as seen in the progression of FIGURES 1-6 and described in [0025-0026]) the locking bracket (47) and being moved in a direction (see movement from FIGURE 1 to FIGURE 6), in which the locking arm (46) becomes closer to or spaced apart (locking arm becomes radially spaced apart from the shaft in FIGURE 6, see [0028-0030], compared to FIGURE 1) from the shaft (53),
wherein the hook recess or the hook (see [0024]: 43 comprises deflectable arms 46 and therefore a ‘hook’ is formed of the inside surface of the arm 46) is formed in the locking arm (46).
Regarding claim 3, the modified system of Gilbert teaches the medicine injection tip of claim 2, and Gilbert discloses further comprising: a guide (51, see FIGURE1) provided in the cylinder (5) and configured to guide movement (see [0024]: 51 actuates==guides movement of deflectable arms 46 to release coupling between 43/54) of the locking arm (46).
Regarding claim 4, the modified system of Gilbert teaches the medicine injection tip of claim 3, and Gilbert further discloses wherein the guide (51, see FIGURE 1) comprises: an unlocking path unit (see ‘Modified FIGURE 6’ below, where arms 46 of 43 travel into in FIGURE 5 to subsequently become “unlocked” from the shaft 53 as shown in FIGURE 6 and described in [0024])
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configured such that the locking arm (46, see ‘Modified FIGURE 5’ below) is moved (arm 46 continues to move from FIGURE 4, through position of FIGURE 5, and into position in FIGURE 6. See [0024]) while being spaced apart (see ‘Modified FIGURE 5’ below) from the shaft (53)
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and while the hook recess and the hook are unlocked from each other (FIGURE 5 shows arms 46, including hook, and shaft 53, including shaft recess, “unlocked” from each other since arm 46 and shaft 53 are no longer touching to decouple the mechanism as described in [0024]); and a locking path unit (see ‘Modified FIGURE 6’ above) configured such that the locking arm (46) is moved while being adhered to (such as shown in FIGURE 4) the shaft (53) and while the hook recess (see where hook 46 is coupled to shaft at a radially recessed position relative the cylinder in ‘Modified FIGURE 1’ above. See coupling description in [0023-0024]) and the hook (see [0024]: 43 comprises deflectable arms 46 and therefore a ‘hook’ formed of the inside surface of the arm) are locked to each other (FIGURE 4 shows arms 46 forming hook in contact/ coupled to shaft 53 including hook recess as described in [0023]: coupling between components transfers force while moving piston of syringe).
Regarding claim 6, the modified system of Gilbert teaches the medicine injection tip of claim 4, and Gilbert further discloses wherein the guide (51, see FIGURE 1) comprises a gradient path unit (see slope of the ‘locking path unit’ as labeled in ‘Modified FIGURE 6’ above) having a specific gradient (slope=change in vertical distance/ change in horizontal distance of the locking path unit ramped structure which would be the ‘specific’ gradient when using the actual values of the distances in the calculation) between the unlocking path unit (see ‘unlocking path unit’ as labeled in ‘Modified FIGURE 6’ above) and the locking path unit (see ‘locking path unit’ as labeled in ‘Modified FIGURE 6’ above).
Regarding claim 7, the modified system of Gilbert teaches the medicine injection tip of claim 6, and Gilbert further discloses wherein the locking arm (46, see ‘Modified FIGURE 4’ below)
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further comprises: a first outer diameter unit (see ‘Modified FIGURE 4’ above) protruding and extending from the locking bracket (47); a gradient unit (see ‘Modified FIGURE 4’ above. The gradient unit follows the slope of the locking arm 46) having a specific gradient (slope=change in vertical distance/ change in horizontal distance of the locking arm which would be the ‘specific’ gradient when using the actual values of the distances in the calculation) corresponding to (gradient unit and gradient path unit are identical==correspond as shown in ‘Modified FIGURE4’ above with parallel/identical slopes) the gradient path unit (as seen in ‘Modified FIGURE 4’ above) and protruding and extending from the first outer diameter unit (see ‘Modified FIGURE 4’ above); and a second outer diameter unit (see ‘Modified FIGURE 4’ above) stepped (see vertical increase from first outer diameter to second) from the first outer diameter part (as seen in ‘Modified FIGURE 4’ above), having an outer diameter that is larger than that of the first outer diameter unit (as seen in ‘Modified FIGURE 4’ above), and protruding and extending from the gradient unit (as seen in ‘Modified FIGURE 4’ above).
Regarding claim 16, Gilbert discloses a medicine injection tip (see [0003]: medicine injection performed with the device) comprising:
a cylinder (5, see FIGURE 1);
a shaft (53) positioned in the cylinder (5) and movable in a first direction toward an extended position (see [0019]: 53 moves distally towards needle 22 and see progression of shaft movement from FIGURE 1 to FIGURE 4);
a needle unit (24 contains needle 22, see [0016]); and
a locking unit (43, see [0024]: 43 comprises deflectable arms) positioned between (see ‘Modified FIGURE 1’ below for reference. Locking unit 43 located such that it is sandwiched between the shaft 53 and needle unit 24)
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the shaft (53) and the needle unit (24) and operable to lock or unlock the needle unit (24, see [0020]: needle unit 24 decouples/unlocks from shaft 53 by way of deflectable arms as described in [0023-0024]) and the shaft (53), the locking unit (43) and the shaft (53) defining a coupling including a hook recess (see where hook 46 is coupled to shaft at a radially recessed position relative the cylinder in ‘Modified FIGURE 1’ above. See coupling description in [0023-0024]) and a hook (see [0024]: 43 comprises deflectable arms 46 and therefore a ‘hook’ formed of the inside surface of the arm) provided on one or the other of the shaft (hook recess on shaft 53) and the locking unit (hook on locking unit), respectively, such that the hook (43) unlocks from the hook recess (recess of shaft 53) to unlock the shaft (53, see [0023-0024]: decoupling locking unit from shaft by way of hook and hook recess decoupling).
Gilbert is silent to the shaft movable in a first direction toward an extended position “and a second direction toward a retracted position” and the hook unlocks from the hook recess to unlock the shaft “in response to the shaft moving in the second direction toward the retracted position”.
However, Pedersen teaches a medicine injection tip comprising a locking unit (710 including bores 715/716, see ‘Modified FIG. 13a’ below for reference and [0123])
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and a shaft (760, see Fig. 13a) movable in a second direction toward a retracted position (as shown in the rightward figure of FIG. 13a). Pedersen further teaches a hook recess (recess of bore 716, see [0123]) is provided in any one of the shaft and the locking unit (710), and wherein a hook (716) operable to be locked to or unlocked from (as shown in FIG. 13a and described in [0123]) the hook recess (recess of bore 716) is provided in the other of the shaft (hook 761 on shaft 760, see [0120] & [0122]) and the locking unit, and the hook (761) unlocks from (see progression of middle figure in Fig.13a to rightward figure) the hook recess (recess of bore 716) to unlock the shaft (760) in response to the shaft moving away from the skin (shaft moves proximally as shown by arrow in ‘Modified FIG. 13a’ above and described in [0123]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hook mechanism between the shaft and locking unit disclosed in Gilbert to unlock the hook and hook recess in response to the shaft moving away from the skin as taught by Pedersen for the purpose of allowing the coupling to act as a damper to initially slow down the speed of the plunger while ensuring that the shaft and coupling do not dampen the injection speed during medication delivery (see [0122-0125]), which would be beneficial to Gilbert that has the shaft in a distal position after decoupling, thus achieving the shaft movable in a first direction toward an extended position “and a second direction toward a retracted position” and the hook unlocks from the hook recess to unlock the shaft “in response to the shaft moving in the second direction toward the retracted position”.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gilbert in view of Pedersen as applied to claim 4 above, and further in view of Houser et al. (U.S. PGPUB No. 2012/0116389), hereinafter Houser.
Regarding claim 5, Gilbert discloses the medicine injection tip of claim 4, and Gilbert further discloses wherein the unlocking path unit (see ‘Modified FIGURE 6i’ below)
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is stepped (see vertical change from locking path to unlocking path in ‘Modified FIGURE 6i’ above) from the locking path unit (see ‘Modified FIGURE 6i’ above).
Gilbert further discloses that the drive mechanism and coupling/decoupling mechanism can be of any configuration that allows a desired dose of medicament to be delivered (see [0019-0020]).
Gilbert is silent to the unlocking path unit “has an inner diameter that is relatively larger than that of the locking path unit.”
However, Houser teaches a shaft coupling mechanism (see Fig. 11 unless otherwise specified and see [0066] describing coupling) between a shaft (452) and a locking unit (464), wherein a hook recess (456) is provided in any one of the shaft (452) and the locking unit, and wherein a hook (460) locked to or unlocked from (unlocked as shown in Fig. 11) the hook recess (456) is provided in the other of the shaft and the locking unit (464). Houser further teaches a guide (internal surfaces of 468 including surface 472) provided in a cylinder (468, see FIG.12) and configured to guide movement (see [0067-0068]: arm 462 is closed==moved as surface 472 moves over arms) of a locking arm (462), wherein the guide comprises: an unlocking path unit (see ‘Modified FIG. 12’ below)
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configured such that the locking arm (462) is moved (in direction ‘C’ as shown in Fig. 11) while being spaced apart (as seen in Fig. 11—see longitudinal spacing between 464 and 452) from the shaft (452) and while the hook recess (456) and the hook (460) are unlocked from each other (as seen in Fig. 11—hook and hook recess NOT coupled and are therefore “unlocked”); and a locking path unit (472, see ‘Modified FIG. 12’ above) configured such that the locking arm (462) is moved while being adhered to the shaft (452) and while the hook recess (456) and the hook (460) are locked to each other (see [0068]: arms remain in locked position until desired distal advancement is achieved. At the desired distal advancement, the arms will decouple again from shaft). Lastly, Houser teaches wherein the unlocking path unit is stepped from the locking path unit (see ‘Modified FIG. 12’ above) and has an inner diameter that is relatively larger than that of the locking path unit (see ‘Modified FIG. 12’ above).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the coupling/decoupling mechanism actuated by the guide comprising the unlocking and locking unit disclosed in Gilbert with the coupling/decoupling mechanism actuated by the guide comprising the unlocking and locking unit, wherein the unlocking path unit is stepped from the locking path unit such that the inner diameter is relatively larger than the locking path unit as taught by Houser for the purpose of selectively securing the distal end of the device to the proximal drive mechanism via the locking and unlocking path units (see [0068]), thus achieving the unlocking path unit “has an inner diameter that is relatively larger than that of the locking path unit.”
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Gilbert in view of Pedersen as applied to claim 1 above, and further in view of Wagner (U.S. Patent No. 4,393,870).
Regarding claim 8, Gilbert discloses the medicine injection tip of claim 1, and Gilbert further discloses wherein the cylinder (5, see FIGURE 1) is configured to supply a medicine to a vicinity of the skin (see [0016]: syringe cartridge effects expulsion of medicament through needle and thus is “configured to” supply a medicine to a vicinity of the skin, or tissue as in [0019]), into which a needle (22) is inserted (see [0019]: needle penetrates==is inserted into tissue).
Gilbert is silent to the cylinder configured to supply the medicine “when a negative pressure is formed at the vicinity of the skin”
However, Wagner teaches a medicine injection tip (see FIG. 7) comprising a cylinder wherein the cylinder is configured to supply medicine when a negative pressure is formed at the vicinity of the skin (see col. 6 lines 42-56: negative pressure is formed at skin and releases medicine through 273).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cylinder configured to supply medicine disclosed in Gilbert to supply the medicine when a negative pressure is formed at the vicinity of the skin as taught by Wagner for the purpose of lifting the skin toward the injection needle to avoid pressure on blood vessels during injection (see col. 1 lines 57-64), thus achieving the cylinder configured to supply the medicine “when a negative pressure is formed at the vicinity of the skin”
Regarding claim 10, the modified system of Gilbert teaches the medicine injection tip of claim 8, and Gilbert further discloses wherein the needle unit (24, see FIGURE 1) comprises: a plunger (walls 26 forming syringe cartridge from distal end 29 to proximal end 27, see ‘Modified FIGURE 3’ below and [0016])
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forming a first space (space within rectangular outline of the plunger as shown in ‘Modified FIGURE 3’ above) and a second space (see ‘Modified FIGURE 3’ above with a second space between the needle and skin and similar to Applicant’s second space 614 between the plunger and skin as in at least FIG. 4 and [0062]) in an interior of the cylinder (5); and the needle (22) disposed in the first space (space within rectangular outline of the plunger as shown in ‘Modified FIGURE 3’ above) and fixed to (see [0016]: needle 22 affixed to 29 which forms distal end of plunger as seen in ‘Modified FIGURE 3’ above) the plunger (walls 26 forming syringe cartridge from distal end 29 to proximal end 27, see ‘Modified FIGURE 3’ above), wherein the plunger (walls 26 forming syringe cartridge from distal end 29 to proximal end 27, see ‘Modified FIGURE 3’ above) comprises a channel (44, see [0022]: channel between syringe 24 an external surface of outer plunger 41) connecting the first space (space within rectangular outline of the plunger as shown in ‘Modified FIGURE 3’ above) and the second space (see ‘Modified FIGURE 3’ above with a second space between the needle and skin).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Gilbert in view of Pedersen and Wagner as applied to claim 10 above, and further in view of AN (U.S. PGPUB No. 2020/0093996).
Regarding claim 11, the modified system of Gilbert teaches the medicine injection tip of claim 10, and Gilbert further discloses wherein the needle (22, see FIGURE 1) forms an invasion hole, through which the needle (22) is inserted into (see [0019]: needle penetrates into tissue and therefore must form an invasion hole where the needle penetrates) and discharged from the skin (see [0028-0029]: needle retracted from tissue/ skin after delivery of medication), as the needle unit (24) is moved (as seen in the progression from FIGUREs 1-6—needle starts fully retracted in FIGURE 1, reaches full extension in FIGURE 3, and is fully retracted again in FIGURE 6).
Gilbert is silent to “wherein a negative pressure is formed in the second space such that the medicine is [[supplied via suction]] suctioned when the needle is inserted into the skin, and wherein a positive pressure is formed in the second space such that the medicine is injected into the invasion hole when the needle is discharged from the skin.”
However, An teaches a medicine injection tip (600, see FIG. 3) with a needle unit (622, see FIG. 3), a needle (621, see FIG.3), and a plunger (623, see FIG. 4 for all following numerals and see [0089]: plunger 623) comprising a second space (2) and a first space (1) connected by a channel (3, see [0097]), wherein the needle (621) forms an invasion hole (see [0088]: depth of invasion hole may be 2.1mm into skin and [0092]: needles invaded into skin), through which the needle 9621) is inserted into and discharged from the skin (see [0091]: plunger applies reciprocating movement and therefore needles are inserted and retracted from skin), as the needle unit (622) is moved (see movement in FIG. 5 showing downward movement of needle unit to penetrate skin on the left and upward movement to discharge the needles from skin), wherein a negative pressure is formed in the second space (2, see [0092]: negative pressure formed in the second space) such that the medicine is [[supplied via suction]] suctioned (see [0100]: negative pressure suctions skin and therefore medicine left at skin “is suctioned”, aligning with 112b interpretation above) when the needle (621) is inserted into the skin (as shown on the left-side figure of FIG. 5), and wherein a positive pressure is formed in the second space (2, see [0092]: when needles 621 are discharged from skin, a positive pressure is formed in the second space) such that the medicine is injected into the invasion hole (see [0101]: medicine is deeply injected into invasion hole under the positive pressure) when the needle (621) is discharged from the skin (as shown in the right-side figure of FIG.5 and described in [0092]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the negative pressure formed in the vicinity of the skin taught by Gilbert in view of Wagner to be formed specifically in the second space as taught by AN for the purpose of invading the needle to a uniform/ preset depth depending on the medical design condition (see [0100]), thus achieving “wherein a negative pressure is formed in the second space such that the medicine is [[supplied via suction]] suctioned when the needle is inserted into the skin”.
Next, therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second space disclosed in Gilbert to have a positive pressure formed when medicine is being discharged to skin as taught by AN for the purpose of using the positive pressure to aid in medicament delivery such that the medication is injected deeply into the invasion hole formed by the needle (see [0101]), thus achieving “and wherein a positive pressure is formed in the second space such that the medicine is injected into the invasion hole when the needle is discharged from the skin.”
Regarding claim 12, the modified system of Gilbert teaches the medicine injection tip of claim 10, but Gilbert is silent to “wherein electric energy is applied to the needle.”
However, An teaches a medicine injection tip (600, see FIG. 3) with a needle (621), wherein electric energy is applied to the needle (see [0004]: a high frequency is applied to needles, which is equated to electrical energy and [0083-0084]: electrical energy is applied to the one or more needles 621.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Modified Gilbert to include an electrical energy that is applied to the needle as taught by AN for the purpose of removing waste tissue of the skin (see [0124]), thus achieving “wherein electric energy is applied to the needle.”
Regarding claim 13, the modified system of Gilbert teaches the medicine injection tip of claim 10, but Gilbert is silent to “wherein electric energy applied to the needle generates thermal energy in the skin.”
However, An teaches a medicine injection tip (600, see FIG. 3) with a needle (621), wherein electric energy (see [0004]: high frequency==applied electrical energy) applied to the needle (621) generates thermal energy in the skin (see [0029]: high frequency generates thermal energy in skin and [0082]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Modified Gilbert to include an electrical energy that is applied to the needle such that thermal energy is generated in the skin as taught by AN for the purpose of removing waste tissue of the skin (see [0124]), thus achieving “wherein electric energy applied to the needle generates thermal energy in the skin”.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Gilbert in view of Pedersen as applied to claim 1 above, and further in view of AN (U.S. PGPUB No. 2020/0093996).
Regarding claim 14, the modified system of Gilbert teaches the medicine injection tip of claim 1, but Gilbert is silent to “A hand piece on which” the medicine injection tip of claim 1 “is mounted.”
However, AN teaches a hand piece (500, see FIG.3) on which a medicine injection tip (600) is mounted (see FIG. 3 and [0062]: medicine tip mounted onto hand piece and [0064]: detachably mounted).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medicine injection tip disclosed in Gilbert to include and be mountable to a hand piece as taught by AN for the purpose of forming the driving mechanism within a hand piece (see [0062]) that is held and modified for use by a doctor (see [0061]), thus achieving “A hand piece on which” the medicine injection tip of claim 1 “is mounted.”
Regarding claim 15, the modified system of Gilbert teaches the medicine injection tip of claim 1, but Gilbert is silent to “A skin treatment device comprising:” the medicine injection tip of claim 1, “and a hand piece, on which the medicine injection tip is mounted.”
However, AN teaches a skin treatment device (1000, see FIG.2 and [0051-0052]) comprising a medicine injection tip (600, see FIG.3) and a hand piece (500), on which the medicine injection tip (600) is mounted (see FIG. 3 and [0062]: medicine tip mounted onto hand piece and [0064]: detachably mounted).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medicine injection tip disclosed in Gilbert to be formed as a skin treatment device comprising a hand piece and the medicine injection tip mountable to the hand piece as taught by AN for the purpose of forming the driving mechanism within a hand piece (see [0062]) that is held and modified for use by a doctor (see [0061] and [0054]), thus achieving “A skin treatment device comprising:” the medicine injection tip of claim 1, “and a hand piece, on which the medicine injection tip is mounted.”
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The amended limitation as argued has been taught by the new reference Pedersen and therefore the new 35 U.S.C. § 103 claim rejection under Gilbert in view of Pedersen meets all claimed limitations of at least claims 1 and 16.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783