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 .
Status of the Claims
Claims 1-16 are pending.
Claim Objections
Claims 1-6, 10 and 12-16 are objected to because of the following informalities:
claims 1-6 and 12-16 contain references to the figures in parenthesis, which should be deleted;
claim 4 needs the term “and” before “octapeptides”;
claim 10 needs the term “and” before “cocoamidopropyl”, and the term epidermal should not be capitalized;
claim 12 states the phrase “wherein the predetermined amount of the hydrocolloid polymer material and the predetermined amount of the hydrocolloid polymer material are dispersed in the water”, which repeats the same component twice; and
claim 12 states “the predetermined amount of crosslinking agent being selected such that the crosslinking agent is dispersed at a concentration of 0.001 to 0.02% by weight… is present in the aqueous solution”, but the terms “is present” should be deleted.
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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-6, 9 and 12-14 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.
Regarding claims 2-6 and 12-13, the phrases “preferably” and “in particular” render the claims indefinite because it is unclear whether the limitations following the phrases are part of the claimed invention. Similarly, claim 9, the phrase “a cosmetic treatment of chronically damaged skin” renders the claim indefinite because it is unclear whether the limitation(s) are part of the claimed invention or merely an example of the cosmetic treatment of the skin. Also, claim 14, the phrase “(neutral oil)” renders the claim indefinite because it is unclear whether the limitation(s) in parenthesis are part of the claimed invention or merely an example. See MPEP § 2173.05(d).
Instant claim 5 states that the crosslinking agent includes cocoamidopropyl betaine. However, claim 1 states that the crosslinking agent contains at least one aldehyde group. Cocoamidopropyl betaine does not contain an aldehyde group. Therefore, it is unclear how the crosslinking agent can be cocoamidopropyl betaine since it does not have an aldehyde.
Claim 12 recites the limitation “foaming of the aqueous solution with the crosslinking agent dissolved therein” in lines 11-12 of pg. 4. There is insufficient antecedent basis for this limitation in the claim. The claim previously states that the crosslinking agent is dispersed in the aqueous solution.
Claims 7-9 and 16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The instant claims recite the intended use for the bioactive pad, but they do not further limit the components of the bioactive pad or the method steps for the production of said bioactive pad. Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
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 1-14 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nesrin et al. (DE 102013111322 A1).
Regarding claim 1, Nesrin et al. disclose hydrocolloid sponges comprising a silk peptide, a hydrocolloid polymer material and a crosslinking aldehyde ([0027], [0041], [0050]; Claims 1-9). The sponges are prepared by foaming the composition comprising a hydrocolloid polymer material ([0053]).
Nesrin et al. disclose preparation of a sponge comprising silk peptide, gelatin, epidermal growth factor EGF and glutaraldehyde, wherein the sponge is prepared by dissolving 2 g of gelatin and 2 g of silk peptide in distilled water, 1 ml of crosslinking agent (e.g., 0.1-5% glutaraldehyde) is added and then the layer forming on the top is removed and frozen ([0062]).
The amount of glutaraldehyde is therefore 0.001 to 0.05% by weight of the composition (1 ml of a solution comprising 0.1-5% glutaraldehyde added to 100 ml distilled water is 0.001 to 0.05% glutaraldehyde in the distilled water solution).
Regarding claim 2, Nesrin et al. do not explicitly disclose the diameter of the pores formed in their foam.
However, Nesrin et al. disclose the formation of a foam with the same components as instantly claimed. Nesrin et al. further disclose a process comprising mixing the same components as instantly claimed forming a foam and freezing ([0061]-[0065]). In the absence of evidence to the contrary, the sponge according to Nesrin et al. will inherently have pores having a diameter of less than 1.0 mm.
Regarding claim 3, Nesrin et al. disclose incorporating ceramides in the hydrocolloid sponge to protect the skin from drying out and itching ([0032], [0047], [0050], [0057]-[0058], [0062]-[0064], [0066]; Claim 5).
Regarding claim 4, Nesrin et al. disclose adding epidermal growth factor, fibroblast growth factor, insulin-like growth factor, and/or silk peptides in the sponges ([0044], [0050]-[0051], [0057]-[0058], [0061]-[0064]; Claims 1-2).
Regarding claim 5, Nesrin et al. disclose the crosslinking agent glutaraldehyde and the foaming agent cocoamidopropyl betaine being incorporated into their sponges ([0033], [0049]-[0050], [0053], [0062]-[0065], [0067]-[0068]; Claim 7).
Regarding claim 6, Nesrin et al. disclose that the hydrocolloid sponge must be fully absorbed by the body ([0040]).
Regarding claims 7-9, Nesrin et al. disclose hydrocolloid sponges comprising the instantly claimed components. Nesrin et al. further disclose the treatment of external wounds and/or skin irritations, as well as chronic wounds ([0001]-[0003], [0007], [0028], [0030], [0039]-[0040], [0072]; Claim 8).
Regarding claims 10 and 11, Nesrin et al. disclose that the combination of a silk peptide and a hydrocolloid polymer material may be layered. For example, the hydrocolloid sponge may comprise a layer of silk peptide and a layer of hydrocolloid polymeric material. The active ingredients may be part of the silk peptide layer and/or part of the hydrocolloid polymer material layer. In addition, one or both layers may comprise ceramides. In a particular embodiment of the invention, the layer of silk peptide may comprise ceramides and/or the hydrocolloid sponge layer may contain growth factors such as EGF (epidermal growth factor) (see, for example, Figure 1) ([0056]-[0057]).
Regarding claims 12-14 and 16, Nesrin et al. disclose dissolving a hydrocolloid polymer and crosslinking agent in water with mixing and foaming, and freezing the foam ([0061]-[0065]). Nesrin et al. further teach adding ceramides, growth factors, and cocoamidopropyl betaine to the hydrocolloid polymer solution, as discussed above.
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Nesrin et al. (DE 102013111322 A1) as applied to claims 1-14 and 16 above, further in view of Nur et al. (US 2011/0045034 A1).
The teachings of Nesrin et al. are discussed above.
Nesrin et al. do not explicitly disclose sterilizing the hydrocolloid sponge by irradiation with gamma rays, as instantly claimed.
Nur et al. teach crosslinked gelatin sponges for treating a wound, wherein any sterilization method known in the art that does not degrade the biological compounds which are sensitive to thermal procedures can be used including, but not limited to, electron beam irradiation, gamma irradiation, ethylene oxide (EtO) sterilization. In one embodiment of the invention, the ready to use sponge and packaging material are sterilized together using, for example, gamma radiation ([0107]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare the hydrocolloid sponges according to Nesrin et al. followed by sterilization by irradiation with gamma rays, as reasonably suggested by Nur et al. A person of ordinary skill in the art would have been motivated to irradiate the sponges of Nesrin et al. with gamma rays in order to effectively sterilize the sponges for packaging and use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nathan W Schlientz whose telephone number is (571)272-9924. The examiner can normally be reached 10:00 AM to 6:00 PM, Monday through Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571) 272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.W.S/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616