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 .
Information Disclosure Statement
The submitted information disclosure statement (IDS) were filed on 09/08/2023, 01/03/2024, 12/30/2024 and 03/16/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Restriction
Applicants' election with traverse of Group II (claims 13-20) in the reply filed on 03/09/2026 is acknowledged. The traversal is on the grounds that Billon et al. does disclose administration of tamoxifen to patients who have undergone breast reconstruction surgery, including procedures involving implants and tissue expanders and does not teach or suggest the claimed method of treating or preventing capsular contracture or capsule formation through localized administration of tamoxifen, which is not found persuasive because the groups of inventions lack unity of invention because even though the inventions of these groups require a
method for treating/preventing capsular contracture or capsule formation in a subject with an implant, comprising administering tamoxifen or a derivative, formulation, or metabolite thereof, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Billon et al. (JPRAS; 2017). Billon et al. discloses administration of tamoxifen to patients who have received breast reconstruction surgery, including implants and tissue expanders (p. 1496, col. 2; p. 1500, Table 5). Billon already teaches the composition, and it is no longer novel or inventive. Therefore, any technical feature linking the method to that composition loses its status as a "special" feature, destroying the single inventive concept.
In accordance with 37 CPR 1.499, the claims must be restricted.
Group I, claim(s) 1-12, drawn to a method for treating/preventing capsular contracture or capsule formation in a subject with an implant, comprising administering tamoxifen or a derivative, formulation, or metabolite thereof.
Group II, claim(s) 13-20, drawn to a surgical implant conjugated to tamoxifen or a metabolite thereof.
The requirement is still proper and is therefore made FINAL. For examining purpose, Claims 13- 20 of Group II are examined in this office action.
Applicant further elects, as a species, tamoxifen, with traverse.
Multiple distinct species can require a serious search and examination burden. And under MPEP § 806.04(f), restriction between species is proper if the species are mutually exclusive and do not overlap in scope. Tamoxifen and its metabolite are not mutually exclusive species, so restriction can be removed.
The requirement for Applicant to elect a species is removed and tamoxifen or tamoxifen metabolite is accepted, which is made FINAL in claims 15-20.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 13-14 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hunter et al. (US 20070208134A1).
Claim 13,
Hunter et al. teach implants and tissue surrounding the devices or implants and provides compositions that comprise anti-fibrotic drug combinations, and their uses in various medical applications including the prevention of surgical adhesions, treatment of inflammatory arthritis, treatment of scars and keloids, the treatment of vascular disease, and the prevention of cartilage loss, (Abs) and anti-scarring drug combination and use thereof (Title). One of the compounds is applied in this prior art is antiestrogenic compound, tamoxifen (K-1). (0657).
With regard to claims 14 and 16,
Hunter et al. teach delivering a composition to a site of treating patients undergoing surgical, (0012), ear ventilation tubes, devices comprising a film or a mesh, (0009), a breast implant in a patient in need thereof, to a site of a cardiac procedure in a patient in need thereof, where the composition comprises an anti-scarring drug combination, (0026), vascular stents, (0061).
Tamoxifen is a non-steroidal estrogen antagonist, used alone or as an adjunct to surgery and/or radiation therapy for the treatment of breast cancer, including Tamoxifen metabolites. (0658). “ Release of an agent from an implant/device refers to any statistically significant presence of the agent, or a subcomponent thereof , which has dissociated from the implant/device. (0063).
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 non-obviousness.
Claim(s) 13 and 15, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al. (US 20070208134A1) in view of Palumbo et al. (AU 2004246812 B2).
The teachings of Hunter et al. are described in claims 13 above.
Palumbo et al. teach treating or preventing excessive scarring, including keloid and hypertrophic scars, by administering 4-hydroxy tamoxifen to a patient with excessive scarring or a wound at risk for developing excessive scarring. (Abs).
Claim 15,
Palumbo et al. teach endoxifen, which is 4-hydroxy-N-desmethyltamoxifen, a metabolite of Tamoxifen. (Figure 1., pg. 1 of 2 of structures, or pdf pg. 34 ).
Claims 17-18,
Hunter et al. teach the clinical function of numerous medical implants and devices is dependent upon the device being able to effectively maintain an anatomical, or surgically created, space or passageway. (0003). The prevention of post - operative adhesions using a photo polymerized polyethylene glycol-co-lactic acid diacrylate hydrogel and a physically crosslinked polyethylene glycol co-polypropylene glycol hydrogel, POLOXAMER 407. (West and Hubbell , Biomaterials (1995) 16:1153 – 1156). (0005).
Hunter et al. do not teach a gel form of tamoxifen or its metabolites.
Palumbo et al. teach for practicing the present invention, preferred formulations contain 4-hydroxy tamoxifen in a hydroalcoholic gel. (pg. 11, lines 1-2).
Use of 4-hydroxy tamoxifen for the preparation of a pharmaceutical composition for treating or preventing scars, or a wound or incision at risk for developing excessive scarring, by local administration. (Claim 1, pg. 29).
A use or a method according to any one of claims 1 to 6, wherein said 4-hydroxy tamoxifen is delivered by an implant of a controlled release polymer or other
delivery device that incorporates 4-hydroxy tamoxifen. (Claim 9, pg. 29).
4-hydroxy tamoxifen is formulated in a percutaneous administration form selected from the following list: an ointment, a cream, a patch, a gel, an emulsion, a powder and an oil. (Claim 17, pg. 30).
4-hydroxy tamoxifen may be administered in any dosage form and via any system that delivers the active compound to a wound or scar in vivo. Preferably, the administration is performed by a means that delivers 4 hydroxy tamoxifen locally, limiting systemic exposure to the drug. For example, 4 10 hydroxy tamoxifen, alone or in combination with a pharmaceutically acceptable vehicle, can be topically applied to the surface of a wound or scar site, can be injected into a wound or scar site, or can be incorporated in to a controlled release polymer and surgically implanted in a region to be treated. (pg. 8, lines 6-13).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to Use of 4-hydroxy tamoxifen for the preparation of a phannaceutical composition for treating or preventing scars, taught by Hunter and Palumbo, wherein 4-hydroxy tamoxifen is delivered by an implant of a controlled release polymer formulated as a gel, taught by Palumbo et al. since they have proven it would be feasible to do so and have provided results that tamoxifen metabolite can help reduce scarring.
Claim(s) 13 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al. (US 20070208134A1) in view of Palumbo et al. (AU 2004246812 B2) and further in view of Rouanet et al. (Rouanet et al., Neoadjuvant Percutaneous 4-Hydroxytamoxifen Decreases Breast Tumoral Cell Proliferation: A Prospective Controlled Randomized Study Comparing Three Doses of 4-Hydroxytamoxifen Gel to Oral Tamoxifen. J Clin Oncol 23, 2980-2987. 2005).
The teachings of Hunter et al. are described in claim 13 above.
Hunter et al. do not teach the dose of tamoxifen or metabolite to treat or prevent breast cancer.
Rouanet et al. teach 4-OHT gel, administered percutaneously on the breast skin, to inhibit the proliferation of malignant breast cells 4-OH-Tam r 4-OHT gel (0.5, 1, or 2 mg/d). (Abs).
Palumbo et al. teach treatment and prevention of excessive scarring with 4-hydroxy tamoxifen. (Title). In a topical formulation, doses on the order of 0.25 to 3 µg of 4-hydroxy
tamoxifen/cm2/day should achieve the desired result, (pg. 9, line 13-16), which is also applied for local delivery or implant.
For practicing the present invention, preferred formulations contain 4-hydroxy tamoxifen in a hydroalcoholic gel. The amount of 4-hydroxy tamoxifen per 100 grams of gel may range from about 0.001 gram to about 1.0 gram., (pg. 11, lines 1-5), or the amount of 4-hydroxy tamoxifen per 100 mg of gel may range from about 0.001 mg to about 1.0 mg. Palumbo et al. tested the dose 0.5-2mg/day. (Table 2, pg. 18). Depending on the amount of gel to be injected in the implant, the amount of 4-hydroxy tamoxifen to be delivered can be less than or greater than the amount given to treat breast cancer.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to Use of 4-hydroxy tamoxifen for the preparation of a pharmaceutical composition for treating or preventing scars, taught by Hunter and Palumbo, wherein 4-hydroxy tamoxifen is delivered by an implant of a controlled release polymer formulated as a gel, and the dose tested at 0.5-2mg/day, or depending on the amount of gel injected, taught by Palumbo et al. since they have proven it would be feasible to do so and have provided results that tamoxifen metabolite can help reduce scarring.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGOC-ANH THI NGUYEN whose telephone number is (571)270-0867. The examiner can normally be reached Monday - Friday 8:00 am.
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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