DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the preliminary amendments received on 26 November 2024. Claims 1-19 are currently pending.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been received.
Drawings
The drawings received on 26 November 2024 are accepted by the examiner.
Claim Objections
Claim 3 is objected to because of the following informalities:
In line 3, it appears that the phrase “where fiber itself” should read “wherein each fiber” for clarity.
In line 3, it appears that the phrase “with drugs material” should read “with drug material.”
Claim 5 is objected to because of the following informality:
In line 2, it appears that the phrase “a first and a second layer” should read “a first layer and a second layer” for clarity.
Claim 7 is objected to because of the following informality:
In line 2, it appears that the phrase “the space” should read “a space.”
Claim 8 is objected to because of the following informality:
In line 2, it appears that the phrase “carrier fibres (14) and drug-loaded fibres (15)” should read “carrier fibers (14) and drug-loaded fibers (15)” for consistency.
Claim 9 is objected to because of the following informalities:
In line 1, it appears that the phrase “the carrier fibres” should read “the carrier fibers” for consistency.
In line 2, it appears that the phrase “the drug-loaded fibres” should read “the drug-loaded fibers” for consistency.
Claim 12 is objected to because of the following informality:
In line 3, it appears that the phrase “the fibres” should read “the fibers” for consistency.
Claim 13 is objected to because of the following informality:
In line 2, it appears that the phrase “comprises at one or more of” should read “comprises one or more of.”
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.
Claims 12 and 15 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 12, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitations following the phrase (i.e. nanocapsules or nanospheres) are part of the claimed invention (see MPEP § 2173.05(d)).
Note: It appears that amending lines 2-3 of claim 12 to read “wherein the drug is held by a carrier, wherein the carrier is nanocapsules or nanospheres, and wherein the carrier is attached to the fibers of the patch” would overcome this rejection. For examination purposes, claim 12 will be treated as such.
Claim 15 recites the limitation "the...blade" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Note: It appears that amending line 1 of claim 15 to read “The felting set according to claim 6” would overcome this rejection (see line 2 of claim 6 for antecedent basis). For examination purposes, claim 15 will be treated as such.
Regarding claim 15, the phrase "particularly preferred" renders the claim indefinite because it is unclear whether the limitations following the phrase (i.e. 0.1 to 0.5 mm) are part of the claimed invention (see MPEP § 2173.05(d)).
Note: It appears that amending lines 2-3 of claim 15 to read “a diameter of 0.1 to 2 mm, 0.1 to 1 mm, or 0.1 to 0.5 mm” would overcome this rejection. For examination purposes, claim 15 will be treated as such.
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 1-2, 4, 7-9, 13, 16 and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bachmann et al. (International Publication WO 2020/227838).
Bachmann et al. disclose (as to claim 1) a felting set (i.e. set defined by 1 and 30) capable of attaching an implant (1) to soft tissue (3) comprising a felting device (30) and the implant, wherein the implant comprises a patch (9) comprising a non-woven material (see page 10, lines 7-9 referring to the fibers being randomly aligned, or aligned to achieve unidirectional stiffness properties) made of individual fibers (2), wherein the fibers have a length of 20 to 80 mm (see page 10, lines 11-14 referring to the fibers having a length of 2 to 500 mm and page 16, lines 6-7 referring to the fibers having a length of 20 to 60 mm), wherein the patch comprises a drug (e.g. antibiotics, see page 10, lines 22-25); and wherein the felting device includes a felting needle (10) capable of delivering the fibers of the patch into the soft tissue (see Figure 1), wherein (as to claim 2) the drug is attached to the fibers or part of fibers (see page 11, lines 3-6 referring to the fibers being incorporated into the patch, and page 10, lines 22-25 referring to the patch being covered or soaked with drugs), wherein (as to claim 4) the patch comprises a first layer (i.e. layer defined by 9) and a second layer (15), wherein the first and second layers differ in strength (i.e. due to different materials being used, see page 3, lines 29-34), wherein (as to claim 7) the drug is held in a space in between the fibers (see page 10, lines 22-25 referring to the patch being covered or soaked with drugs; given this, it is the examiner’s position that a portion of the drug would be held in the space between the fibers), wherein (as to claim 8) the patch comprises carrier fibers (i.e. fibers of monofilament or multifilament nature) and drug-loaded fibers (2) (i.e. the carrier fibers are used to improve stiffness and patch stability, while the drug-loaded fibers are felted into the soft tissue, see page 11, lines 3-6), wherein (as to claim 9) the carrier fibers have a larger diameter than the drug-loaded fibers (see claim 7 referring to fibers of monofilament or multifilament nature having a larger diameter), wherein (as to claim 13) the drug comprises antibiotics (see page 10, lines 22-25), wherein (as to claim 16) the drug is liquid or solid and loaded by soaking the patch (see page 10, lines 22-25), wherein (as to claim 18) a first visible region (i.e. peripheral region defined by 9) is marked (i.e. clearly defined, see Note 1 below regarding the term “marked”), the first region being loaded with a first drug and/or being a region suitable to be felted to soft tissue (i.e. via 2), and wherein (as to claim 19) a second visible region (i.e. peripheral region defined by 9) is marked (i.e. clearly defined, see Note 1 below regarding the term “marked”), the second region being loaded with a second drug and/or being a region to be felted to soft tissue for a particular application (i.e. via 2) (see Figures 1-8, page 3, lines 29-34 and page 8, line 23 – page 18, line 3).
Note 1: For examination purposes and in light of the broadest reasonable interpretation, the term “marked” is being interpreted as clearly defined and evident; noticeable (definition retrieved from https://www.thefreedictionary.com/marked).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bachmann et al. (International Publication WO 2020/227838), as applied to claim 1 above, in view of Alessandrino (U.S. Patent Application Publication 2017/0312387).
Bachmann et al. disclose wherein (as to part of claim 3) the fibers are polymer fibers (see page 10, lines 1-3); however, fail to explicitly disclose wherein (as to the remainder of claim 3) the polymer fibers comprise a hybrid structure of drugs and polymer, wherein each fiber is made of a chemically hybrid composition with drug material and polymer material.
Alessandrino teaches the use of polymer fibers (13/14, see paragraph 0046), wherein the polymer fibers comprise a hybrid structure (see paragraph 0046) of drugs (see paragraph 0050) and polymer (i.e. fibroin, see paragraph 0005), wherein each fiber is made of a chemically hybrid composition with drug material and polymer material (see paragraph 0073) (see Figure 1, and paragraphs 0005 and 0046-0190).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Bachmann et al. with wherein the polymer fibers comprise a hybrid structure of drugs and polymer, wherein each fiber is made of a chemically hybrid composition with drug material and polymer material in view of Alessandrino in order to provide an alternative, well-known and obvious means for repairing tissue with a regenerative medicine approach to yield predictable results.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bachmann et al. (International Publication WO 2020/227838), as applied to claim 1 above, in view of Labib et al. (U.S. Patent Application Publication 2018/0200185).
Bachman et al. disclose wherein (as to part of claim 5) the patch comprises a first layer (i.e. layer defined b 9) and a second layer (15); however, fail to explicitly disclose wherein (as to the remainder of claim 5) the first layer comprises a first drug and the second layer comprises a second drug and wherein the first drug and the second drug have different degradation rates.
Labib et al. teach the use of a fabric or mesh (i.e. similar in function to a patch) impregnated with drugs capable of being released over a time, wherein the release rate, drug quantity, and location are capable of being controlled (see paragraphs 0003 and 0004).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Bachmann et al. with wherein the first layer comprises a first drug and the second layer comprises a second drug and wherein the first drug and the second drug have different degradation rates in view of Labib et al. in order to provide a well-known, obvious means for delivering desired drugs to the soft tissue to yield predictable results.
Claims 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Bachmann et al. (International Publication WO 2020/227838), as applied to claim 1 above, in view of Levine et al. (U.S. Patent Application Publication 2016/0038141).
Regarding claim 6, Bachmann et al. disclose the claimed invention except for wherein a distal end of a needle tip is at a radially outer edge and a blade extends across a cross-section of the needle to an opposing other radially outer edge.
Levine et al. teach the use of tissue penetrating member (3), wherein a distal end (15) of a member tip (i.e. tip defined at right-most side of 15 as bests seen in Figure 2) is at a radially outer edge (i.e. right-most edge) and a blade (i.e. blade defined by beveled surface) extends across a cross-section (i.e. cross-section as best seen in Figure 4) of the needle to an opposing other radially outer edge (i.e. left-most side of 15 as bests seen in Figure 2) (see Figures 2 and 4, and paragraph 0121-0127).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Bachmann et al. with wherein a distal end of a needle tip is at a radially outer edge and a blade extends across a cross-section of the needle to an opposing other radially outer edge in view of Levine et al. in order to provide a well-known, obvious tip shape for easily penetrating soft tissue to yield predictable results.
Regarding claim 15, Bachmann et al. in view of Levine et al. disclose the claimed invention except for wherein the largest cross-section of the needle or blade has a diameter of 0.1 to 2 mm, 0.1 to 1 mm, or 0.1 to 0.5 mm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Bachmann et al. in view of Levine et al. with wherein the largest cross-section of the needle or blade has a diameter of 0.1 to 2 mm, 0.1 to 1 mm, or 0.1 to 0.5 mm in order to provide a desired needle size for felting the patch to soft tissue since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art (In re Rose, 105 USPQ 237 (CCPA 1955)).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Bachmann et al. (International Publication WO 2020/227838), as applied to claim 1 above, in view of Richter (U.S. Patent Application Publication 2003/0064965).
Regarding claim 10, Backmann et al. disclose the claimed invention except for wherein the patch comprises liposomes or micelles, wherein the liposomes or micelles carry the drug.
Richter teaches the use of liposomes as a drug carrier applied to a medical device (see paragraphs 0035-0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Bachmann et al. with wherein the patch comprises liposomes or micelles, wherein the liposomes or micelles carry the drug in view of Richter in order to provide a well-known, obvious means for quickly releasing the drug from the carrier upon contact with the soft tissue to yield predictable results.
Regarding claim 11, Backmann disclose wherein the needle includes a pointed tip (16) (see Figure 4A). It is the examiner’s position that the pointed tip is fully capable of damaging the liposomes as taught by Richter such that that the drug is released by the needle while felting the patch (see Note 2 below regarding functional language).
Note 2: Regarding functional language, "[a]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (see MPEP 2114(II)).
Regarding claim 12, Backmann et al. disclose the claimed invention except for wherein the drug is held by a carrier, wherein the carrier is nanocapsules or nanospheres, and wherein the carrier is attached to the fibres of the patch.
Richter teaches the use of nanocapsules as a drug carrier applied to a medical device (see paragraphs 0035-0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Bachmann et al. with wherein the drug is held by a carrier, wherein the carrier is nanocapsules or nanospheres, and wherein the carrier is attached to the fibers of the patch in view of Richter in order to provide a well-known, obvious means for releasing the drug from the fibers of the patch to yield predictable results.
Claims 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Bachmann et al. (International Publication WO 2020/227838), as applied to claim 1 above.
Regarding claim 14, Bachmann et al. disclose wherein (as to part of claim 14) the needle comprises at least one barb (11), wherein the at least one barb has a depth of 0.1 mm (see Figure 4A, and page 17, lines 8-9).
Bachmann et al. disclose the claimed invention except for wherein (as to the remainder of claim 14) the at least one barb has a depth of 0.005-0.05 mm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Bachmann et al. with wherein the at least one barb has a depth of 0.005-0.05 mm in order to provide a desired barb depth for catching an pushing the fibers into the soft tissue since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art (In re Rose, 105 USPQ 237 (CCPA 1955)).
Regarding claim 17, Bachmann et al. disclose wherein (as to part of claim 17) the patch comprises a first region (i.e. first layer defined by 9) and a second region (15).
Bachmann et al. disclose the claimed invention except for wherein (as to the remainder of claim 17) the first region is loaded with the drug and the second region is not loaded with the drug of the first region.
However, Bachmann et al. teach the second region providing an anchoring or reinforcing function to the patch (see page 3, lines 29-34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Bachmann et al. with wherein the first region is loaded with the drug and the second region is not loaded with the drug of the first region since the second region provides an anchoring or reinforcing function to the patch and Bachmann et al. are silent to the second region being soaked with drugs there are a finite number of identified, predictable elements of the patch that can be loaded, or not loaded, with the drug to yield predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775
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