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 .
Priority
Acknowledgments are made that this application claims the priority to the following:
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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 10-11 and 15-16 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 pre-AIA the applicant regards as the invention.
The claims recite the word “preferably”, which renders the claims indefinite for the following reasons:
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(d). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "preferable" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, claim recites the broad recitation, and the claim also recites the narrower statement of the range/limitation.
Claim Rejections - 35 USC§ 112(d)
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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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.
Claim 10 is 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.
To establish whether a claim is properly dependent upon another claim, the claims must refer to a previously presented claim and then specify a further limitation of the subject matter claimed. A dependent claim does not lack compliance with 35 U.S.C. 112, fourth paragraph, simply because there is a question as to (1) the significance of the further limitation added by the dependent claim, or (2) whether the further limitation in fact changes the scope of the dependent claim from that of the claim from which it depends.
In the present case, it appears that the product of claim 10 comprises additional component, which is broader in scope than that of its independent claim, which is limited to jellyfish collagen hydrolysate. Accordingly, the dependent claim 10 does not narrow down the scope of independent claims and in fact it significantly broaden the scope.
Applicant may cancel the claim(s), or amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(i) Claims 1-7, 9, 11-13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ding (Food Hydrocolloids, 2011, 25, 1350-1353).
For claims 1-3:
Ding discloses jellyfish collagen hydrolysate [see title and abstract].
Ding further teaches preparation of jellyfish collagen hydrolysate with the following method:
Jellyfish was rinsed with distilled water, then treated with 10 v(v/w) of 0.1 mol/L NaOH and stirred for 2d to remove non-collagenous proteins at 4 °C. The insoluble fraction was suspended in PB buffer (pH 7.0), and then digested with 2%(w/v) protamex at 50 °C for 8 h. The solutions were heated at 100 °C for 10 min to inactivate the enzyme, and then centrifuged at 4000 r/min for 10 min. The supernatant were jellyfish collagen hydrolysate and stored at −20 °C until use. [See section 2.2.1 in page 1351].
The above is interpreted as ‘a collagenous marine invertebrate extract’, given an additional fact that the jellyfish is invertebrate.
The phrase “for use in the treatment of” for the recited disease or condition, is an intended use limitation that has no effect on the body of the claim if removed. Therefore, it does not further limit the broadest reasonable interpretation of claim(s). See MPEP 2111.02(II). Accordingly, the prior art does not have to show a treatment of the recited diseases or disorders, and so claims are fully anticipated.
For claim 4:
These are nothing but properties of the jellyfish collagen hydrolysate. Since product is identical, and so these properties are inherent. Claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
For claims 5-7:
Ding discloses that jellyfish in their disclosure belongs to class Scyphozoa, and species Rhizostomeae esculentum [see Introduction].
For claim 9:
As explained For claims 1-3 above, the supernatant in the Ding disclosure is interpreted as solution or sponge matrix.
For claim 11:
Though administration is associated with intended use, but Ding discloses concentration of 5 ml kg-1 d-1 and 10 ml kg-1 d-1 [see section 2.2.3].
For claims 12-13 and 15:
As explained under For claims 1-3 above, in the disclosure of Ding, the separated supernatant is interpreted as pharmaceutical composition or formulation, because it also comprises other components, at least water, which can also be a pharmaceutically acceptable compound. The recited “used for…” intended use and, it does not have any weight, as explained under For clams 1-3 above.
Accordingly claims are fully anticipated.
(ii) Claims 16 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ding (Food Hydrocolloids, 2011, 25, 1350-1353).
Ding discloses jellyfish collagen hydrolysate [see title and abstract].
Ding further teaches preparation of jellyfish collagen hydrolysate with the following method:
Jellyfish was rinsed with distilled water, then treated with 10 v(v/w) of 0.1 mol/L NaOH and stirred for 2d to remove non-collagenous proteins at 4 °C. The insoluble fraction was suspended in PB buffer (pH 7.0), and then digested with 2%(w/v) protamex at 50 °C for 8 h. The solutions were heated at 100 °C for 10 min to inactivate the enzyme, and then centrifuged at 4000 r/min for 10 min. The supernatant were jellyfish collagen hydrolysate and stored at −20 °C until use. [See section 2.2.1 in page 1351].
The above is interpreted as ‘a collagenous marine invertebrate extract’, given an additional fact that the jellyfish is invertebrate. The supernatant is nothing but recovering the hydrolyzed material and centrifugation is interpreted as purification step prior to a recovering the hydrolyzed material.
Accordingly, claims are fully anticipated.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
(i) Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ding (Food Hydrocolloids, 2011, 25, 1350-1353) in view of Chen (WO 2011/140526 A1).
For claims 1-7, 9, 11-13 and 15, see above 102 rejection.
For claim 8:
Ding silent on species Rhizostomas pulmo in their disclosure. However, Ding provided guidance on closely related species, viz., Rhizostomas esculentum, and so, Rhizostomas pulmo is expected to have same or similar collagen and therefore, it is obvious to extrapolate teachings of Ding to Rhizostomas pulmo and extract or make jellyfish collagen hydrolysate, absent evidence to the contrary.
For claim 10:
Though administration is associated with intended use, however it can be cured from the teachings of Chen, which teaches treating dystrophic epidermolysis bullosa (DEB) by administering the composition of C7, a mini C7 and aminoglycoside, such as gentamicin, paromomycin or G418 etc. [see 0047-0053].
For claim 14:
Ding is silent on additional components in their composition or extract. However it can be cured from the teachings of Chen, which teaches treating dystrophic epidermolysis bullosa (DEB) by administering the composition of C7, a mini C7 and aminoglycoside, such as gentamicin, paromomycin or G418 etc. [see 0047-0053]. Generally, if it is known to use A, and known to use B for the same purpose, then it is obvious to use both A and B, In re Susi, 169 USPQ 423, 426; In re Kerkhoven, 205 USPQ 1069. Thus, combining them flows logically from their having been individually taught in the prior art.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components in the composition and their utilities, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed product with a reasonable expectation of success.
(ii) Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ding (Food Hydrocolloids, 2011, 25, 1350-1353) in view of Addad (Marine Drugs, 2011, 9, 967-983).
For claims 16-17, see above 102 rejection.
For claim 18:
Ding is silent on purification by membrane filtration or chromatographic techniques, however, these are well known in the art. For example, Addad teaches isolation and purification of jellyfish collagen using chromatography [see section 2.3 Biochemical characterization of R.pulmo fibrillar collagen; Experimental Section]. Therefore, this limitation is obvious over the known art on purification of collagen.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants collagen and its purification techniques etc., were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed product with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658