DETAILED ACTION
Status of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 11, 13, 15, 18-20, 23, 29-37, and 39-43 are cancelled.
Claims 1-10, 12, 14, 16, 17, 21, 22, 24-28, and 38 are pending.
Claim Interpretation
Claim 1 recites “decidua tissue” which the specification discloses, “The decidua is a mucosal tissue of the uterus. … The decidua basalis is the maternal part of the placenta.” ([0005]). Examiner interprets “decidua tissue” with the broadest reasonable interpretation to include placental tissue.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9, 12, 17, 21, 22, and 24-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 is drawn to a composition comprising dehydrated decidua tissue. The broadest reasonable interpretation of a composition would be the material that is named, that is, the dehydrated decidua tissue by itself. Decidua tissue is a naturally-occurring product, and reference to the specification shows that is obtained directly from the uterus, “The decidua is a mucosal tissue of the uterus that forms in preparation for pregnancy. … The decidua basalis is the maternal part of the placenta. The decidua is generally discarded even if the remaining placental tissue is to be processed into placental products” ([0005]) therefore not undergoing “any of the known refining steps”. Dehydrated decidua tissue is dehydrated which contains less water or no water; however, the structure is not markedly changed. Thus, the composition of claim 1 is not markedly different from the decidua tissue as it occurs in nature. It is not integrated into a practical application because nothing in claim 1 relies on or uses the exception. There is nothing significantly more than the judicial exception because there are no additional elements in the claim. With regard to claims 2-9, 12, 17, 21, 22, and 24-27, the enumeration of the ingredients does not make the extract markedly different from how it occurs in nature.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception, because the composition at the broadest interpretation of the claim language is dehydrated decidua tissue, which does not appear to change the biological/pharmacological functions, chemical/physical properties, or the structure/form of said ingredients. Because the claimed composition does not have markedly different characteristics, it is a product of nature.
Claim Rejections - 35 USC §102/103
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 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.
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.
Claims 1-10, 12, 14, 16, 17, 21, 22, 24-28, and 38 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Morse et al. (US20190374584A1) hereinafter Morse.
Anticipation
Morse is drawn to composition composed of micronized placental components and pharmaceutical compositions thereof and methods for making and using the micronized compositions (abstract).
Morse discloses once the amnion, chorion, and/or intermediate tissue layer have been dehydrated individually or in the form a of tissue graft, the dehydrated tissue(s) is micronized. The particle size of the materials in the micronized composition can vary as well depending upon the application of the micronized composition. In one aspect, the micronized composition has particles that are less than 500 μm, less than 400 μm, less than 300 μm [0040]. Morse discloses the composition is prepared by admixing a micronized composition with a pharmaceutically-acceptable compound and/or carrier [0051]. Morse discloses the composition as a powder [0054]. Morse discloses the micronized compositions are useful in enhancing or improving wound healing [0070].
Morse discloses polyethylene glycol (PEG) 600 in the composition [0101].
Morse discloses the use of the freeze-dryer to dehydrate the tissue can be more efficient and thorough compared to other techniques such as thermal dehydration. In general, it is desirable to avoid ice crystal formation in the placental tissue as this may damage the extracellular matrix in the tissue. By chemically dehydrating the placental tissue prior to freeze-drying, this problem can be avoided [0037].
Obviousness
Morse does not explicitly disclose the composition in a single embodiment as claimed.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Morse, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Morse discloses each of the components dehydrated placental tissue (abstract; [0040]) and discloses Morse discloses the use of the freeze-dryer to dehydrate the tissue can be more efficient and thorough compared to other techniques such as thermal dehydration. In general, it is desirable to avoid ice crystal formation in the placental tissue as this may damage the extracellular matrix in the tissue. By chemically dehydrating the placental tissue prior to freeze-drying, this problem can be avoided [0037].
Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation... 103 likely bars its patentability...if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions......the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615