DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 232.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 224.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2-3 & 10-11 are objected to because of the following informalities.
Claim 2 should read --The needle roller device for skin injection according to claim 1, wherein the main body includes an injection passage formed therein,
the expansion part includes a plurality of distribution passages communicating with the injection passage, and
each distribution passage of the plurality of distribution passages includes a distribution nozzle formed at an end thereof.—
Claim 3 should read –each
Claim 10 should read -- The needle roller device for skin injection according to claim 9, wherein the first round jaw is fitted into a central through hole of the second disk cover,
the second round jaw is closely coupled to an entrance of a central through hole of the first disk cover, and
the stopper is fitted into the through hole of the hinge bracket such that of the rotation connection part are supported
Claim 11 should read --The needle roller device for skin injection according to claim 3, wherein the cut groove is recessed inwardly into the distribution nozzle, and an end of each of the plurality of fine needles
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/areas follows.
“drug injection device” in Claim 1, where the generic placeholder is “device”, the functional language is “drug injection”, and sufficient modifying structure is not provided; the instant application describes the drug injection device as “an injector that automatically injects the drug or a syringe to manually inject the drug”, providing sufficient modifying structure
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 Objections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 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.
The claim(s) are replete with indefinite language. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. An attempt to point out as much of the indefinite language as possible was attempted and shown below. However, due to the extensive amount of indefinite language, some of the indefinite language may have been missed. Applicant is advised to carefully review the claim language and amend any indefinite language to present a complete operative device.
As to Claim 1, the term “the other side”, in Line 3, should read –an
The term “an outer circumferential surface”, in Line 7, is incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the structure which has the outer circumferential surface. For the purpose of examination, the term will be interpreted as an outer circumferential surface of the roller part.
The phrase “fine needles”, in Line 7, should read –a plurality of fine needles.
The phrase “fine needles…exposed to outside”, in Lines 7-8, is a relative term which renders the claim indefinite. The term “outside” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The instant application states the needles may be exposed outside of the needle protrusions. However, it is not clear if that is what is intended with this limitation. As such, it is not clear what structure the fine needles are exposed outside relative to. For the purpose of examination, the phrase will be interpreted as fine needles…exposed outside of the needle protrusions.
As to Claim 3, the term “a tip” is incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the structure which has the tip. For the purpose of examination, the term will be interpreted as a tip of the distribution nozzle.
As to Claim 5, the limitation “the needle block is formed by coupling first and second disk covers and fine needle disks positioned between the disk covers to each other”, in Lines 3-4, should read –each of the connected needles blocks is formed by coupling first and second disk covers; a fine needle disk is first and second disk covers
The limitation “the first and second disk covers include a plurality of needle protrusions protruding from an outer circumferential surface” is indefinite. It is not clear if the needle protrusions defined in Claim 5 are the same needle protrusions defined in Claim 1, or if the respective needle protrusions are different. For the purpose of examination, the needle protrusions of Claim 5 will be interpreted as the needle protrusions of Claim 1.
The term “an outer circumferential surface”, in Line 6, is incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the structure which has the outer circumferential surface. For the purpose of examination, the term will be interpreted as an outer circumferential surface of each of the first and second disk covers. Additionally, the outer circumferential surface defined in Claim 1 is interpreted as being part of the roller part, and the disk covers are part of the roller part. As such, it is not clear if the outer circumferential surface of Claim 5 is the same outer circumferential surface as defined in Claim 1, or if the respective surfaces are different. For the purpose of examination, the two surfaces will be interpreted as the same surfaces.
The limitation “the fine needle disk includes a plurality of fine needles formed radially on an outer circumferential surface” is indefinite. It is not clear if the fine needles defined in Claim 5 are the same fine needles defined in Claim 1, or if the respective fine needles are different. For the purpose of examination, the fine needles of Claim 5 will be interpreted as the fine needles of Claim 1.
Additionally, the term “the fine needles disk” should read --each needle of the fine needle disks.
The limitation “the fine needles are configured to be inserted into each needle protrusion, with an end of the fine needle protruding out of the needle protrusion” should read –each fine needles of the plurality of fine needles are configured to be respectively inserted into each needle protrusion of the plurality of needle protrusions, with an end of each fine needle of the plurality of fine needles protruding out of the respective needle protrusion of the plurality of needle protrusions.
As to Claim 6, the term “tips” is incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the structure which has the tips. For the purpose of examination, the term will be interpreted as tips of the needle protrusions.
As to Claim 7, the phrase “the other side”, in Line 3, should read –an
The limitation “the fine needle disk includes a plurality of fine needles radially formed on an outer circumferential surface” is indefinite. It is not clear if the plurality of fine needles in Claim 7 is the same plurality of fine needles in Claims 1 or 5. For the purpose of examination, the plurality of fine needles in Claim 7 will be interpreted as the same plurality of fine needs as in Claims 1 & 5.
The term “an outer circumferential surface”, in Lines 5-6, is incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the structure which has the outer circumferential surface. For the purpose of examination, the term will be interpreted as an outer circumferential surface of each of fine needle disk. Additionally, the outer circumferential surface defined in Claim 1 is interpreted as being part of the roller part, and the fine needles disk is part of the roller part. As such, it is not clear if the outer circumferential surface of Claim 7 is the same outer circumferential surface as defined in Claims 1 & 7, or if the respective surfaces are different. For the purpose of examination, the surfaces will be interpreted as the same surfaces.
The term “center”, in Line 6, is incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the structure which has the center. For the purpose of examination, the term will be interpreted as a center of each of fine needle disk.
The limitation “the fine needles are exposed only to the outside of the needle protrusions” is indefinite in light of the specification. Instant application Figure 3 shows the fine needles 224 exposed to the outside of the needle protrusions as well as the inside of the needle protrusions. As such, it is not clear how the fine needles are only exposed to the outside of the needle protrusions, since the fine needles are also exposed to the inside of the needle protrusions. Additionally, it is not clear if the outside in Claim 7 is the same outside defined in Claim 1, or if the respective outsides are different outsides. For the purpose of examination, the respective outsides will be interpreted as the same outside.
As to Claim 9, the limitation “a second round jaw protruding apart from the first round jaw to be caught and fixed on an outer circumferential surface of a needle block” should read --a second round jaw protruding from the outer surface and spaced apart from the first round jaw to be caught and fixed on an outer circumferential surface of a needle block.
The term “an outer circumferential surface of a needle block” is indefinite. The outer circumferential surface defined in Claim 1 is interpreted as being part of the roller part, and the needle block is part of the roller part. As such, it is not clear if the outer circumferential surface of Claim 9 is the same outer circumferential surface as defined in Claim 1, or if the respective surfaces are different. For the purpose of examination, the two surfaces will be interpreted as different surfaces.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 & 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (KR20180055066A – see attached translation).
As to Claim 1, Lee teaches a needle roller device (10) for skin injection (Paragraph 0033), comprising:
a main body (120) comprising, formed on (as shown in Figure 2) one side (the top of 120, as viewed in Figure 2) thereof, an injection pipe part (see Figure 2 below) with an injection port (see Figure 2 below) to which a drug injection device (300/400) is detachably coupled (Paragraph 0040), and formed on (as shown in Figure 2) the other side (the bottom of 120, as viewed in Figure 2) thereof, an expansion part (see Figure 2 below) with predetermined width (see Figure 2 below) and length (see Figure 2 below) communicating with (as shown in Figure 2) the injection pipe part (see Figure 2 below);
a roller part (110) rotatably coupled to (Paragraph 0023; as shown in Figure 2) the expansion part (see Figure 2 below), and comprising a plurality of needle protrusions (see Figure 2 below) formed on (as shown in Figure 2) an outer circumferential surface (see Figure 2 below), and fine needles (112) coupled to (as shown in Figure 2) the plurality of needle protrusions (see Figure 2 below) and exposed to (as shown in Figure 2) outside (Figure 2 shows each of needles 112 extending radially past the needle protrusions); and
a rotation connection part (123a/123b) that fastens (as shown in Figure 2) the main body (120) and the roller part (110).
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Lee Figure 2, Modified by Examiner
As to Claim 2, Lee teaches all the limitations of Claim 1, and continues to teach the main body (120) includes an injection passage (121) formed therein (as shown in Figure 2),
the expansion part (see Figure 2 in the Claim 1 rejection above) includes a plurality of distribution passages (see Figure 2 below) communicating with (as shown in Figure 2) the injection passage (121), and
each distribution passage (see Figure 2 below) includes a distribution nozzle (see Figure 2 below) formed at (as shown in Figure 2) an end (the bottom end of the passage, as viewed in Figure 2) thereof.
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Lee Figure 2, Modified by Examiner
As to Claim 3, Lee teaches all the limitations of Claims 1-2, and continues to teach the distribution nozzle (see Figure 2 in the Claim 2 rejection above) includes a cut groove (see Figure 2 in the Claim 1 rejection above) formed at a tip (the bottom of the nozzle shown in Figure 2 in the Claim 1 rejection above).
Lee does not explicitly teach the groove is made via a cut. However, this limitation is considered a product-by-process, and "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." Since Lee already meets the structural limitations of the claim, the groove via a cut limitation is not considered patentable. See MPEP 2113.
As to Claim 4, Lee teaches all the limitations of Claim 1, and continues to teach the expansion part (see Figure 2 in the Claim 1 rejection above) includes (as shown in Figure 2) an outlet (130) on (as shown in Figure 2) an outer surface (the outer surface of 130, as viewed in Figure 2), and
a drain passage (131) connecting (as shown in Figure 2) the outlet (130) and an injection passage (121).
As to Claim 6, Lee teaches all the limitations of Claim 1, and continues to teach the needle protrusions (see Figure 2 in the Claim 1 rejection above) include (as shown in Figure 2) skin pressing parts (as shown in Figure 2) formed (as shown in Figure 2) at tips (the outer radial surface of the needle protrusions shown in Figure 2 in the Claim 1 rejection above) thereof.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lee, in view of Myung (KR101108992B1 – see attached translation).
As to Claim 5, Lee teaches all the limitations of Claim 1, and continues to teach the roller part (110) includes a plurality of connected needle blocks (112a/112b/112c/112d).
Lee does not teach the structure of the claimed needles blocks, so does not teach the needle block is formed by coupling first and second disk covers and fine needle disks positioned between the disk covers to each other,
the first and second disk covers include a plurality of needle protrusions protruding from an outer circumferential surface,
the fine needle disk includes a plurality of fine needles formed radially on an outer circumferential surface, and
the fine needles are configured to be inserted into each needle protrusion, with an end of the fine needle protruding out of the needle protrusion.
Myung describes a similar needle roller device, and teaches the needle block is formed by coupling (as shown in Figure 10) first and second disk covers (see Figure 10 below) and fine needle disks (24) positioned between (as shown in Figure 10) the disk covers (see Figure 10 below) to each other,
the first and second disk covers (see Figure 10 below) include (as shown in Figure 10) a plurality of needle protrusions (30) protruding from (as shown in Figure 10) an outer circumferential surface (23a),
the fine needle disk (24) includes a plurality (as shown in Figure 10) of fine needles (25) formed radially on (as shown in Figure 10) an outer circumferential surface (the outer circumferential surface of disk 24, as viewed in Figure 10), and
the fine needles (25) are configured to be inserted into (as shown in Figure 10) each needle protrusion (30), with an end (the radially outward end of 25, as viewed in Figure 10) of the fine needle (25) protruding out of (as shown in Figure 10) the needle protrusion (30).
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Myung Figure 10, Modified by Examiner
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use the roller part, as taught by Myung, in place of the roller part, as taught by Lee, to relieve pain during use (bottom of Page 3).
Allowable Subject Matter
Claims 7-11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
As to Claim 7, the prior art of record teaches all the limitations of Claims 1 & 5 but does not teach “the fine needle disk includes a plurality of fine needles radially formed on an outer circumferential surface, a first through hole formed in a center, and second and third through holes formed on both sides of the first through hole, respectively, the first and second disk covers are coupled to each other with the fine needle disk inserted therebetween, while the pins are passed through the second and third through holes, respectively, and upon coupling the first and second disk covers and the fine needle disk positioned therebetween, the fine needles are exposed only to the outside of the needle protrusions”. Therefore, the prior art of record fails to disclose each of the limitations of Claim 7. The closest art of record is Lee, as modified with Myung (both cited above). However, Lee, as modified, does not teach the claimed pins or through holes. Banar (U.S. PGPub 2017/0049971) teaches a pin (812) protruding from one side (as shown in Figure 8C) of the central through hole (813), and a pin hole (811) formed on the other side (as shown in Figure 8E) of the central through hole (813), but does not teach the respective through holes in the fine needle disk. It would not be obvious to one of ordinary skill in the art to modify Lee, as modified, without significant structural modification and without the benefit of hindsight. Therefore, this limitation, as claimed in Claim 7, is neither anticipated nor made obvious by the prior art of record.
As to Claim 8, the prior art of record teaches all the limitations of Claims 1 & 5 but does not teach “the first and second disk covers include fine needle insertion grooves which are recessed inward and into which the fine needle disk and the fine needle are inserted”. Therefore, the prior art of record fails to disclose each of the limitations of Claim 8. The closest art of record is Lee, as modified with Myung (both cited above). However, Lee, as modified, does not teach the fine needles within the insertion grooves. It would not be obvious to one of ordinary skill in the art to modify Lee, as modified, without significant structural modification and without the benefit of hindsight. Therefore, this limitation, as claimed in Claim 8, is neither anticipated nor made obvious by the prior art of record.
As to Claim 9, the prior art of record teaches all the limitations of Claim 1 but does not teach “a stopper formed at an end of the shaft part and fitted into a through hole of a hinge bracket”. Therefore, the prior art of record fails to disclose each of the limitations of Claim 9. The closest art of record is Lee (cited above). However, Lee does not teach the rotation connection part, as claimed. Myung (cited above) broadly teaches the rotation connection part includes a rod-shaped shaft part, a first round jaw protruding from an outer surface of the shaft part, a second round jaw protruding apart from the first round jaw to be caught and fixed on an outer circumferential surface of a needle block, but the prior art does not teach the stopper within a hinge bracket in combination with the rest of the limitations. It would not be obvious to one of ordinary skill in the art to modify Lee, as modified, without significant structural modification and without the benefit of hindsight. Therefore, this limitation, as claimed in Claim 9, is neither anticipated nor made obvious by the prior art of record.
Claim 10 depends on Claim 9, so would also be found allowable.
As to Claim 11, the prior art of record teaches all the limitations of Claim 1 but does not teach “a stopper formed at an end of the shaft part and fitted into a through hole of a hinge bracket”. Therefore, the prior art of record fails to disclose each of the limitations of Claim 9. The closest art of record is Lee (cited above). However, Lee does not teach an end of the fine needle is introduced into the distribution nozzle, while being spaced apart from an end of the cut groove. It would not be obvious to one of ordinary skill in the art to modify Lee without significant structural modification and without the benefit of hindsight. Therefore, this limitation, as claimed in Claim 11, is neither anticipated nor made obvious by the prior art of record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Chung (2020/0376246) and Pistor (3,918,449) teach similar needle roller devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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