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 .
Claim Objections
Claim 1 is objected to because of the following informalities: Line 3 should recite “the hard planar surface” to match the language of line 2. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: The comma on line 2 should be removed for grammatical correctness. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Line 3 should recite “the protruding affected area” to match the language of line 2. Appropriate correction is required.
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, 6, and 12-13 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.
Claim 1 is rejected because it introduces “a plurality of peripheral portions” on lines 4-5 but then line 6 only refers to the peripheral portion” – so it’s unclear if the limitations of lines 6-7 are intended to refer to all of the peripheral portions or only one single peripheral portion. Based on the disclosure, it appears they should refer to all of the peripheral portions. Additionally, claim 1 recites “an adjacent peripheral portion” on lines 6-7 but it’s unclear if this is intended to be one of the “plurality of peripheral portions” of lines 4-5 or a different peripheral portion all together. Based on the disclosure, it appears these should be part of the “plurality of peripheral portions”. Also, the phrase “folded through a gap” on line 7 is unclear because the phrase “folded through” is not one used commonly – is this intended to mean “folded at a gap”, “folded via a gap”? It is also unclear as to what is being folded. Based on the disclosure, it appears that the patch as a whole is intended to be folded at the gap. In order to overcome these rejections, it is suggested to amend lines 6-7 to recite “wherein each of the peripheral portions is disposed to be spaced apart from an adjacent one of the peripheral portions, and is wherein the microneedle patch is configured to be folded [[through]] at a gap between the adjacent peripheral portions that are adjacent to each other”.
Claim 6 is rejected because like claim 1, it recites “the peripheral portion” and “the adjacent peripheral portion”, and these phrases suffer the same issue as claim 1. For the sake of examination, the phrases “the peripheral portion” and “the adjacent peripheral portion” are interpreted as intending to refer to all of the peripheral portions (instead of one specific peripheral portion) and all of the adjacent peripheral portions (instead of one specific peripheral portion). In order to overcome this rejection, it is suggested to amend lines 1-2 to recite “wherein an area of each of the peripheral portions is greater than an area of the gap between the adjacent peripheral portions that are adjacent to each other”.
Claim 12 is rejected because like claim 1, it recites “the peripheral portion” and this phrase suffers the same issue as claim 1. For the sake of examination, the phrase “the peripheral portion” is interpreted as intending to refer to all of the peripheral portions (instead of one specific peripheral portion). In order to overcome this rejection, it is suggested to amend line 2 to recite “each of the peripheral portions”.
Claim 13 is rejected line 3 recites “a plurality of microneedle patches” but then line 5 refers only to “the microneedle patch”. It’s unclear if all of the microneedle patches have to be like that of claim 1 or not. For the sake of examination, it is interpreted as requiring all the microneedle patches to be like that of claim 1. In order to overcome this rejection, it is suggested to amend lines 5-6 to recite “wherein each of the microneedle patches includes comprises the microneedle patch according to claim 1”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (KR 20220065661 A) in view of Park (KR 200226579 Y1).
Regarding claim 1, Kim discloses a microneedle patch 22+21+30 (seen in Fig 6(a) but having the configuration formed by the mold 10 of Fig 26, such a patch is supported by Para 83) comprising: a microneedle array 21+22+30 including a hard planar substrate 22, and a plurality of microneedles 21 disposed on the hard planar substrate (as seen in Fig 6(a),6(b)), wherein the microneedle array includes a central portion (formed by mold sections 10e+10f of mold 10 of Fig 26) and a plurality of peripheral portions (formed by mold sections 10a, 10b, 10c, and 10d of mold 10 of Fig 26) connected to the central portion and surrounding the central portion (as seen in Fig 26), wherein each of the peripheral portions is disposed to be spaced apart from an adjacent one of the peripheral portion by a gap (as seen in ‘Modified Fig 26’ below, a gap exists between the needles formed by section 10a and the needles formed by section 10b, between the needles formed by section 10b and the needles formed by section 10c, between the needles formed by section 10c and the needles formed by section 10d, and between the needles formed by section 10d and the needles formed by section 10a). Kim does not disclose that the microneedle patch is configured to be folded at the gap between the peripheral portions that are adjacent to each other. However, Park teaches the microneedle patch is configured to be folded at the gap between the peripheral portions that are adjacent to each other (see such folding in Park, p. 10, [0025], lines 6-9, the shape of the slot, moreover, the bent portion of the human body, the length and width can be controlled in order to well adhere closely to the bent portion without overlapping of the part) a gap (Park, Fig. 4 slot 44) between the adjacent peripheral portion (Park, Fig. 4 support member 42).
It would have been obvious before the effective filing date of the claimed invention for a person of ordinary skill in the art to combine the teachings of a microneedle array having central and peripheral portions of the first modified device of Kim et al. with the teachings of the folding through a gap between the peripheral portions, as taught by Park, as Kim et al. discloses a microneedle array (p. 23, [0080], lines 1-2, microneedle 21 array) including a central portion (Kim et al., 10e and 10f) and multiple peripheral portions (see Kim et al., Fig. 26 10a-10d) separated by gaps (see Kim et al., ‘Modified Fig. 26’ below, gap). The first modified device of Kim further teaches that the array remains adhered to the skin for a period sufficient to deliver pharmacological components which indicates that the array is intended to conform to the application surface during use as described in Kim et al., p. 28, [0103], lines 4-8, an area attached to one surface of the microneedle manufacturing mold 10 may be attached to the skin for a period necessary for delivering the pharmacological components included in the microneedles 21a, 21b by maintaining the adhesive force even after the microneedle manufacturing mold 10 is removed for skin application. The first modified device of Kim also teaches that the microneedles and the base portion may be formed separately and may be fabricated from different materials with the base portion including relatively compliant polymeric materials such as carboxymethyl cellulose, hyaluronic acid, polyvinyl alcohol, polyactic acid, PLGA, and PVP as described in Kim et al., p. 22, [0075], lines 1-8, a microneedle array in which the microneedle 21 and the base portion 24 are separately manufactured may be formed. In this case, the microneedle 21 and the base portion 24 may be made of different materials, and preferably, the microneedle 21 and the base portion 24 may be made of at least one selected from carboxymethyl cellulose (cmc), hyaluronic acid (ha), polyvinyl alcohol (pva), polylactic acid (pla), polylactic co-glycolic acid (plga), polyvinylpyrrolidone (pvp), and the like, respectively, but are not limited thereto. Thus, the first modified device of Kim expressly contemplates selecting the base material independently from the microneedles to achieve desired mechanical properties. Park teaches that folding occurs through the gap between adjacent portions of a microneedle array to improve conformity to a curved body surface as described in Park, p. 10, [0025], lines 6-9, the shape of the slot, moreover, the bent portion of the human body, the length and width can be controled in order to well adhere closely to the bent portion without overlapping of the part. A person of ordinary skill in the art would have recognized that incorporating Park’s folding configuration into Kim’s segmented peripheral portions would allow bending to occur preferentially in the gap while the peripheral portions remain substantially rigid from the materials able to be used. Because the peripheral portions are separated by gaps and supported by the adhesive/base structure, the intervening regions provide natural locations for localized bending. Doing so would have predictably improved the ability of Kim’s array to conform to curved anatomical surfaces while maintaining adhesion and effective microneedle engagement which is consistent with the objective of Kim et al. of maintaining skin attachment for drug delivery.
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Regarding claim 2, the device of Kim et al. modified by Park discloses further comprising: a soft substrate (p. 23, [0079], lines 1-3, adhesive sheet 30 may be a sheet made of a thermoplastic substrate such as a metal, a polymer, a fabric, or the like, or a sheet coated with an adhesive on one surface of the sheet), disposed below (p. 23, [0080], lines 2-3, flat surface to attach and fix the upper surface of the microneedle 21) the microneedle array (p. 23, [0080], lines 1-2, microneedle 21 array).
Regarding claim 3, the device of Kim et al. modified by Park discloses the gap (see Kim et al., ‘Modified Fig. 26’ above, gap) is a planar portion (see Kim et al., ‘Modified Fig. 26’ above, planar portion) having a step difference (see Kim et al., ‘Modified Fig. 26’ above, step difference) from the microneedle array (see Kim et al., ‘Modified Fig. 26’ above, protruding microneedle array),
Regarding claim 4, the device of Kim et al. modified by Park discloses the gap (see Kim et al., ‘Modified Fig. 26’ above, gap) is formed by exposing an upper surface (see Kim et al., ‘Modified Fig. 26’ above, soft substrate upper surface) of the soft substrate (Kim et al., 30).
Regarding claim 5, the device of Kim et al. modified by Park discloses the upper surface (see Kim et al., ‘Modified Fig. 26’ above, soft substrate upper surface) of the soft substrate (Kim et al., 30) has adhesion (Kim et al., p. 23, [0079], lines 2-3, coated with an adhesive on one surface of the sheet).
Regarding claim 6, the device of Kim et al. modified by Park discloses an area of the peripheral portion (see Kim et al., Fig. 26 10a-10d) is greater than an area of the gap (see Kim et al., ‘Modified Fig. 26’ above, gap) between the adjacent peripheral portion (an adjacent peripheral portion of, Kim et al., Fig. 26, 10a-10d, other than the peripheral portion, “one of Fig. 26, 10a-10d”).
Regarding claim 7, the device of Kim et al. modified by Park discloses an outer peripheral surface of the central portion (see Kim et al, ‘Modified Fig. 26’ above, outer peripheral surface of the central portion) in contact with the gap (see Kim et al., ‘Modified Fig. 26’ above, gap).
The device of Kim et al. modified by Park does not explicitly mention is rounded. However, Park teaches an outer peripheral surface of the central portion (see Park, ‘Modified Fig. 4’ below, central portion rounded outer peripheral surface), in contact with the gap (see Park Fig. 4 slot 44) is rounded (see Park, ‘Modified Fig. 4’ below, central portion rounded outer peripheral surface).
It would have been obvious before the effective filing date of the claimed invention for a person of ordinary skill in the art to combine the teachings of an outer peripheral surface of the central portion in contact with the gap of Kim et al. with the teachings of a rounded outer peripheral surface of the central portion in contact with the gap, as taught by Park, as Park teaches that such a configuration improves conformity to curved body surfaces, allows the structure to flex with body movement, reduces skin tension, and prevents peeling from the application surface as described in Park, p. 8, [0014], lines 1-8, a technical problem to be solved by the present invention is to solve the above problems and provide a patch which is in close contact with a human body without overlapping the patch even on a curved surface of the human body such as a joint portion such as an ankle, so that the patch can be firmly attached to prevent the patch from falling off, and the patch can be easily changed according to an area of the skin extending even when the joint is bent, thereby preventing the patch from being detached and the skin from being pulled. A person of ordinary skill in the art would have been motivated to incorporate Park’s known rounded configuration into the corresponding structure of Kim et al. to obtain these recognized advantages.
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Regarding claim 8, the device of Kim et al. modified by Park does not explicitly mention further comprising: a protective film disposed on the microneedle patch (although the microneedle patch (see ‘Modified Fig. 6a’ above, microneedle patch) is disclosed in Kim et al). However, Park teaches further comprising: a protective film (Park, p. 11, [0027], lines 1-3, release paper 75) disposed on the microneedle patch (Park, p. 11, [0027], lines 1-3, patch).
It would have been obvious before the effective filing date of the claimed invention for a person of ordinary skill in the art to further modify the device of Kim et al. modified by Park to further comprise the protective film disposed on the microneedle patch, as taught by Park, as Park teaches the release paper is attached to the patch to protect the pharmacodynamic layer attached to the support member as described in Park, p. 11, [0027], lines 1-3, a release paper 75 is attached to protect the pharmacodynamic layer 73 attached to the support member 72 in the patch. Park further teaches that the release paper is formed of an insulating material to prevent the medicinal components from leaking to the outside and is readily removable prior to use as described in Park, p. 11, [0028], lines 1-5, the release paper 75 is preferably made of an insulating material or an insulating material so as to prevent the medicinal components of the weak electrode layer 73 from leaking to the outside, and is made of a vinyl sheet made of a synthetic resin or the like that can be easily removed in general use. Accordingly, a person of ordinary skill in the art would have been motivated to incorporate Park’s protective film into the device of Kim et al. modified by Park in order to protect the active layer, prevent leakage or contamination of the medicinal components during storage and handling, and provide a removable protective covering thereby yielding the predictable result of a protected microneedle patch having improved storage stability, especially with the emphasis of improved storage stability as described in Kim et al, p. 9-10, [0030], lines 1-5, a mold for manufacturing a microneedle manufactured through injection molding does not shrink and bend even after long-term storage compared to thermocompression molding, so that the shape of a product is not changed and the storage stability of the product can be improved.
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (KR 20220065661 A) in view of Park (KR 200226579 Y1) as applied to claims 1, 2, and 4-5 above, and further in view of Yang et al. (KR 102042900 B1).
Regarding claim 9, the device of Kim et al. modified by Park discloses the soft substrate (Kim et al., 30).
The device of Kim et al. modified by Park does not explicitly mention comprises a hydrocolloid layer. However, Yang et al. teaches the soft substrate (see Yang et al., Fig. 1 adhesive tape 200) comprises a hydrocolloid layer (Yang et al., p. 8, [0021], lines 2-4, hydrocolloid).
It would have been obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to modify the device of Kim et al. modified by Park to comprise a hydrocolloid layer, as taught by Yang et al, as Yang et al. teaches that conventional microneedle patches are fabricated by attaching a hydrocolloid adhesive tape to the back surface of a microneedle patch as described in Yang et al, p. 4, [0002], lines 1-4, a conventional microneedle patch is manufactured by attaching a hydrocolloid component attachment tape to a rear surface of the microneedle patch on which a microneedle structure of a hyaluronic acid component is formed. Yang et al. further teaches that the adhesive tape may be made of a hydrocolloid material as described in Yang et al, [0021]. Yang explains that the hydrocolloid adhesive provides adhesion for the microneedle patch while addressing issues associated with proper microneedle penetration into the skin as described Yang et al., p. 11, [0026], lines 9-18, 10 minutes after the microneedle patch comes into contact with moisture, the microneedle film formed of hyaluronic acid or gelatin and the adhesive tape formed of hydrocolloid are expanded and deformed concavely as shown in the photograph, but the bending structure formed of pet is not deformed. Therefore, when the microneedle film formed of hyaluronic acid or gelatin and the adhesive tape formed of a hydrocolloid material are expanded, the bending structure is supported without being deformed, so that the adhesive tape is concavely deformed toward the skin, thereby allowing the microneedle to be inserted into the skin. Accordingly, a person of ordinary skill in the art would have been motivated to incorporate the conventional hydrocolloid layer taught by Yang et al. into the device of Kim et al. modified by Park, in order to provide a conventional skin-compatible adhesive layer that promotes reliable adhesion and effective microneedle insertion, thereby yielding the predictable result of an improved microneedle patch.
Regarding claim 10, the device of Kim et al. modified by Park discloses the microneedle array (Kim et al., p. 23, [0080], lines 1-2, microneedle 21 array) contains a biocompatible polymer (see Kim, p. 24, [0081], line 14, microneedle raw material 20, and see Kim, p. 9, [0025], lines 1-3, the microneedle raw material may be at least one selected from the group consisting of a metal, a non-metal, a biodegradable polymer, and a pharmacological component).
Regarding claim 11, the device of Kim et al. modified by Park discloses the microneedle array (Kim et al., p. 22, [0076], lines 1, microneedle array) contains an active ingredient (Kim et al., p. 22, [0076], lines 2-3, active ingredient).
Regarding claim 12, the device of Kim et al. modified by Park discloses the central portion (see Park, ‘Modified Fig. 4’ above, central portion) is in contact with a protruding affected area (see Park, p. 10, [0024], lines 16-17, bent portion of the human body), and the peripheral portion (see Park, ‘Modified Fig. 4’ above, peripheral portion) surrounds a peripheral portion of the affected area (see Park, p. 10, [0024], lines 18-19, skin portion of the stretched joint) and is in contact therewith (see Park, p. 10, [0024], line 18, attached).
Claims 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (KR 20220065661 A) in view of Park (KR 200226579 Y1) as applied to claim 1, and further in view of Lee (KR 101723599 B1).
Regarding claim 13, the device of Kim et al. modified by Park does not explicitly mention a microneedle patch kit, comprising: a release film; and a plurality of microneedle patches disposed to be spaced apart from each other on the release film. However, Lee teaches a microneedle patch kit (see Lee, Fig. 1a hydrocolloid band set 10), comprising: a release film (see Lee, Fig. 1a film substrate 11); and a plurality of microneedle patches (see Lee, Fig. 1a band unit 12) disposed to be spaced apart (see Lee, Fig. 1a first separation line 111 and second separation line 112) from each other on the release film (see Lee, Fig. 1a film substrate 11).
The device of Kim et al. modified by Park does disclose the microneedle patch (see the first modified device of Kim et al. further modified by Park as described above) includes the microneedle patch according to claim 1 (see the first modified device of Kim et al. further modified by Park as described above).
It would have been obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings of a microneedle patch includes the microneedle patch according to claim 1 of the device of Kim et al. modified by Park with the teachings of a microneedle patch kit, comprising: a release film; and a plurality of microneedle patches disposed to be spaced apart from each other on the release film, as taught by Lee, as Lee teaches that providing multiple patch units on a common release film separated by separation lines enables the individual patches to be easily detached and applied, simplifies manufacture, and prevents loss of individual patches during storage as described in Lee, p. 5, [0009], lines 1-7, the hydrocolloid band set according to the present invention allows each band unit to be easily separated and easily attached. In addition, the hydrocolloid band set according to the present invention has an advantage in that it is simple to manufacture while preventing loss of each band unit during a storage process. In addition, the hydrocolloid band set according to the present invention can be appropriately separated according to the size of the band by forming various types of separation lines. Lee further teaches that the individual band units are intended for attachment to wound sites and may be manufactured as a plurality of band units attached to a film substrate as described in Lee, p. 7, [0015], lines 1-8, the plurality of band units 12 may be manufactured in the form of a band set 10 attached to a wide plate-shaped film substrate 11. Accordingly, a person of ordinary skill in the art would have been motivated to employ Lee’s release-film kit arrangement in the microneedle patch of the modified device of Kim et al. modified by Park to obtain the predictable benefits of improved manufacturing, storage, handling and individual dispensing of multiple microneedle patches.
Regarding claim 14, the device of Kim et al. modified by Park further modified by Lee discloses further comprising: a protective film covering (Park, p. 11, [0027], lines 1-3, release paper 75) and protecting the release film (see Lee, Fig. 1a film substrate 11) and the plurality of microneedle patches (see Lee, Fig. 1a band unit 12).
Regarding claim 15, the device of Kim et al. modified by Park further modified by Lee discloses the release film (see Lee, Fig. 1a film substrate 11) comprises a fracture line (see Lee, Fig. 1a first separation line 111) formed in one direction (p. 7, [0017], lines 1-2, in a direction).
Regarding claim 16, the device of Kim et al. modified by Park further modified by Lee discloses the plurality of microneedle patches (see Lee, Fig. 1a, band unit 12) are disposed on the fracture line (see Lee, Fig. 1a first separation line 111).
Regarding claim 17, the device of Kim et al. modified by Park further modified by Lee discloses the release film (see Lee, Fig. 1a film substrate 11).
The first modified device of Kim et al. further modified by Park further modified by Lee does not explicitly mention further comprises a plurality of microneedle patch receiving portions disposed to be spaced apart from the fracture line. However, another embodiment of 2b of Lee teaches further comprises a plurality of microneedle patch receiving portions (see Lee, Fig. 1b arrangement region 121) disposed to be spaced apart (see being disposed on the second separation line 112 which is spaced apart from the fracture line (first separation line 111) as described in Lee, p. 8, [0020], lines 2-3, may be disposed on the first separation line 111 or the second separation line 112) from the fracture line (see Lee, Fig. 2b first separation line 111).
It would have been obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to modify the device of Kim et al. modified by Park further modified by Lee to include the spaced- apart microneedle patch receiving portions, as taught by Lee, as Lee teaches that forming various types of separation lines allows the band set to be appropriately separated according to the size of the band as described in Lee, p. 5, [0009], lines 5-7, the hydrocolloid band set according to the present invention can be appropriately separated according to the size of the band by forming various types of separation lines. Accordingly, a person of ordinary skill in the art would have recognized that applying Lee’s separation-line arrangement to the microneedle patch kit of Kim et al. further modified by Park further modified by Lee would have predictably permitted individual packaging and separation of microneedle patches of varying sizes.
The device of Kim et al. modified by Park further modified by Lee does not explicitly mention the plurality of microneedle patches are individually packaged by the microneedle patch receiving portions. However, another embodiment of Lee further teaches the plurality of microneedle patches (see Lee, p. 9, [0020], line 14, band unit 12) are individually packaged (see each arrangement region 121 receiving a band unit 12 and being bounded by a separation-prevention structure, each receiving portion defining an individual package for its corresponding microneedle patch as described in Lee, p. 9, [0020], lines 15-20, as an alternative to preventing separation, a boundary line may be formed by cutting along the circumferential surface of the arrangement region 121. A separation prevention structure of the band unit 12 having various structures may be formed on the film substrate 11, and the present invention is not limited to the presented embodiment) by the microneedle patch receiving portions (see Lee, p. 9, [0020], line 17, arrangement region 121).
It would have been obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to modify the device of Kim et al. modified by Park further modified by Lee so the plurality of microneedle patches are individually packaged by the microneedle patch receiving portions, as taught by Lee, as Lee teaches that forming various types of separation lines allows the band set to be appropriately separated according to the size of the band as described in Lee, p. 5, [0009], lines 5-7, the hydrocolloid band set according to the present invention can be appropriately separated according to the size of the band by forming various types of separation lines. Accordingly, a person of ordinary skill in the art would have recognized that applying Lee’s separation-line arrangement to the microneedle patch kit of Kim et al. modified by Park further modified by Lee would have predictably permitted individual packaging and separation of microneedle patches of varying sizes.
Conclusion
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/ISSA JAMIL GHANNOUM/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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