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 Status
Claims 1-8 are pending and under current examination.
Priority
This Application is a CON of PCT/CN2024/118940, filed 09/14/2024. Foreign priority has been claimed to CN 202410476246.X, filed 04/19/2024. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112(b)
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 1-8 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.
Claim 1 recites a “thumbtack needle dressing” and a “hollow thumbtack needle”. The instant specification defines that “Thumbtack needle is a general name for the thumbtack needle type intradermal needle, which resembles a thumbtack” (paragraph [0010]). The specification does not define, and one of ordinary skill in the art would not be reasonably apprised of, the characteristics a needle must possess in order to “resemble a thumbtack”, and the metes and bounds of the claims are uncertain. For purposes of examination and applying prior art, the Examiner interprets that a hollow intradermal needle with a needle tip and a needle body communicated with a drug groove satisfies the limitation of a “hollow thumbtack needle”, and a dressing comprising one or more of such hollow needles satisfies “a thumbtack needle dressing”.
Claim 2-7 are rejected under 35 U.S.C. 112(b) by virtue of their dependency on indefinite claim 1 and failure to cure the deficiency noted above.
Claim Interpretation
The preamble phrase “for hemostasis after an operation” is an intended use of the claimed dressing. From MPEP 2111.02 II.: “If the body of a claim fully and intrinsically sets forth all of the
limitations of the claimed invention, and the preamble merely states, for example, the purpose or
intended use of the invention, rather than any distinct definition of any of the claimed invention’s
limitations, then the preamble is not considered a limitation and is of no significance to claim
construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”. Here, the body of the claim fully and intrinsically sets forth all structural limitations of the claimed dressing, and the Examiner interprets that the intended use does not further limit the claim. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-3, 5, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Wiggin et al. (WO 2023/168353 A1, published September 7th, 2023), hereafter “Wiggin” in view of Jina et al. (US 2008/0058726 A1, published March 6th, 2008), hereafter “Jina”.
Regarding instant claim 1, Wiggin teaches a system to enhance hemostasis including an applicator pad, an applicator device, and a reservoir; the reservoir can be configured to contain medication to be released to the wound via the applicator pad (see entire document, particularly abstract and Fig. 36, portions of which are reproduced below). The system can be used in various settings and during and after various procedures such as after surgery (paragraph [0229]). The applicator pad can include a hemostatic patch including a liquid medication (hemostatic drug layer) (paragraph [0072]). Medications include those desirable to deliver to patients experiencing a wound requiring cessation of bleeding including a hemostatic medication such as an antifibrinolytic (hemostatic drug) (paragraph [0094]). Wiggin teaches the distal side of the applicator pad (i.e., the side of the applicator pad that is configured to be in contact with a wound surface or skin surface of a patient) may include adhesive such that the applicator pad can be adhesively coupled to a target wound area of the patient (is a self-adhesive layer) (paragraph [0228]).
As shown in Fig. 36A of Wiggin (reproduced below), the applicator pad 3110 may be adjacent to an enclosure 3117 containing a medication (drug groove provided with a drug therein) and may include an array of microneedles 3111; the medication may be flowed to the skin of the user via channels within the microneedles (paragraphs [0236]-[0237]). The microneedle may be a hollow structure configured to flow medication into the epidermis (paragraph [0248] and Fig. 36E, reproduced below). The microneedle of Wiggin is therefore interpreted to meet the limitation of a hollow thumbtack needle. The hollow microneedles of Wiggin are shown and described to communicate with the enclosure containing a medication and penetrate through the applicator pad to expose the needle body and tip.
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Wiggin further teaches that the applicator pad can be coupled to a bandage (patch layer) that can include adhesive strips configured to be coupled to the subject’s skin (fixing strap) (paragraph [0086]); microneedles of the applicator pad can remain attached to the patient as a patch after the initial attachment and any suitable adhering element (e.g., an adhesive bandage) can be used (paragraph [0239]).
Regarding instant claim 2, as shown above in Fig. 36A, Wiggin shows the hollow needle vertically connected to a medication enclosure via an inner (middle) part of the enclosure.
Regarding instant claim 3, as noted above, Wiggin teaches that the applicator pad can include a hemostatic patch including a liquid medication (paragraph [0072]). Wiggin further teaches that medications include those desirable to deliver to patients experiencing a wound requiring cessation of bleeding including antifibrinolytics such as aminocaproic acid and tranexamic acid (paragraph [0094]).
Regarding instant claim 5, as noted above, Wiggin teaches that the applicator pad can be coupled to a bandage (patch layer) that can include adhesive strips configured to be coupled to the subject’s skin (fixing strap) (paragraph [0086]).
Regarding instant claim 7, as noted above, Wiggin teaches that medication flows from an enclosure (drug groove) to the skin of the user via channels within microneedles. Wiggin further teaches that the medication can include a pharmaceutical composition including a therapeutically effective amount one or more antibiotics and/or one or more non-steroid anti-inflammatory drugs (paragraphs [0094]-[0095]).
Regarding instant claim 8, Wiggin teaches that the drug reservoir can be formed of material impermeable to, and non-reactive with, the medication or its constituents, such as glass, metal, plastic, polymer (e.g., a rigid polymer such as polyethylene, polypropylene, polyamide, polycarbonate), etc. (paragraph [0074]).
Wiggin suggests that devices may comprise a cap (paragraph [0076]); however, Wiggin does not explicitly teach that a needle cap is provided on the needle tip (instant claim 1).
Jina teaches a device containing microneedles for penetrating a surface, for applications such as transdermal drug delivery (see entire document, particularly abstract and paragraph [0001]). Jina teaches the inclusion of a microneedle tip protection cap (paragraph [0065]) which can be made of an etchant resistant material (paragraph [0069]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the device of Wiggin with the microneedle tip cap of Jina. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to protect the microneedle tips from damage such as from etchants, as suggested by Jina. There is a reasonably expectation of success as Wiggin similarly teaches a microneedle-containing device for transdermal drug delivery, and suggests that devices may comprise a cap.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Wiggin in view of Jina as applied to claims 1-3, 5, and 7-8 above, and further in view of Shefer et al. (US 2003/0175328 A1, published September 18, 2003), hereafter “Shefer”.
The teachings of the modified Wiggin are set forth above. Particularly regarding instant claim 4, Wiggin teaches that the applicator pad can include a hemostatic patch including a medication (paragraph [0072]) such as aminocaproic acid and tranexamic acid (paragraph [0094]), and Wiggin teaches the distal side of the applicator pad may include adhesive such that the applicator pad can be adhesively coupled to a target wound area of the patient (paragraph [0228]).
The combination of Wiggin and Jina does not teach the limitation of instant claim 4 that the hemostatic drug layer is made of a material added with at least one selected from the group consisting of dextrin, starch slurry, and hydroxypropyl cellulose.
Shefer teaches a patch comprising a polymeric matrix layer for controlled topical or transdermal delivery of effective levels of pharmaceutical active ingredients onto the skin (see entire document, particularly Abstract and claim 1). The patch can comprise hemostatic pharmaceutically active ingredients (claim 18) such as aminocaproic acid and tranexamic acid (paragraph [0051]). The polymeric matrix layer comprises materials selected from those including hydroxypropyl cellulose (claim 3, and exemplified in Tables 1, 2, 5, 7, and 9). The polymeric matrix is bioadhesive and water soluble, and the adhesive properties are sufficient to maintain the patch in place on the skin for the recommended treatment period while allowing the patch to be readily removed without causing skin irritation or leaving adhesive residue on the skin; the patch also provides ease of handling and application to the treatment site, comfort, minimal foreign body sensation, and increased residence time for the protection of the affected tissue or the delivery of the active ingredients (see abstract and paragraph [0017]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the hemostatic patch layer in the device of Wiggin in view of Jina to include the hydroxypropyl cellulose taught by Shefer. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to formulate a patch that can effectively deliver hemostatic active agents such as aminocaproic acid and tranexamic acid, and which has sufficient adhesive properties to maintain the patch in place on the skin with minimal foreign body sensation and which can be removed without skin irritation, as suggested by Shefer. There is a reasonably expectation of success as Wiggin similarly teaches a hemostatic patch including medications such as aminocaproic acid and tranexamic acid, and that the applicator pad can be adhesively coupled to a target wound area of the patient.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wiggin in view of Jina as applied to claims 1-3, 5, and 7-8 above, and further in view of Masayuki (JP 2002165828 A, published September 18, 2003).
The teachings of the modified Wiggin are set forth above. Particularly regarding instant claim 6, Wiggin teaches that the applicator pad can be coupled to a bandage (patch layer) that can include adhesive strips configured to be coupled to the subject’s skin (fixing strap) (paragraph [0086]); microneedles of the applicator pad can remain attached to the patient as a patch after the initial attachment and any suitable adhering element (e.g., an adhesive bandage) can be used (paragraph [0239]).
The combination of Wiggin and Jina does not teach the limitation of instant claim 6 that the patch layer is made of a medical adhesive tape, non-woven fabric, or a medical silicone material.
Masayuki teaches a disposable hemostatic bandage comprising an elastic bandage having a skin-adhering portion, the elastic bandage being a polyurethane nonwoven fabric (see entire document, particularly abstract and claims 1-2). The polyurethane nonwoven bandage is breathable and flexible, making it easy to wrap, while being inexpensive (paragraph [0007]), and is user-friendly (see abstract and paragraphs [0001]-[0005]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the bandage (patch) layer in the device of Wiggin in view of Jina to be made of a polyurethane nonwoven fabric, as suggested by Masayuki. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to use an inexpensive and user-friendly bandage material that is breathable and flexible, and which is known for use in hemostatic applications, as suggested by Masayuki. There is a reasonably expectation of success as Wiggin similarly teaches an adhesive bandage to affix a hemostatic device to a patient’s skin.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUDITH M KAMM whose telephone number is (703)756-4575. The examiner can normally be reached M-F 8:00 am-4:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611
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