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.
Claim 12 is amended.
Claims 1-10, 12, 14, 16, 17, 21, 22, 24-28, and 38 are pending.
Response to Arguments
Applicant’s remarks filed 5/22/2026 have been fully considered, and the arguments on pages 10-12 regarding the prior art rejections are persuasive to withdraw the rejections under 35 USC 102/103 over the Morse reference.
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.
Response to Arguments
Applicant’s remarks filed 5/22/2026, in particular the arguments on pages 6-10 regarding the 35 USC 101 rejection have been fully considered.
Applicant argues on page 7 that examiner, “does not analyze the claimed dehydrated state, non-viability, powder form, particle-size profile, film or sheet form, carrier formulation, hydrogel-forming behavior, or viscosity behavior. Those are precisely the types of structural, physical, and functional characteristics that must be considered in determining whether the claimed product is markedly different from the natural counterpart”.
However, examiner recognizes that dehydrated decidua tissue is different from hydrated decidua tissue in situ because there is less/no water, and a dehydrated decidua tissue might possess properties of being “stiffer’; however, the dehydrated decidua tissue is still decidua tissue that is not markedly different because there are no markedly different functional/structural changes as the dehydrated decidua tissue in all other ways is identical with the exception of having less/no water, and having less water does not alter the tissue such that it makes it patent eligible.
Applicant argues on page 7 that, “the claims are directed to a composition comprising dehydrated decidua tissue, and the dependent claims further recite manufactured physical forms and properties, including non-viable tissue, powder, lyophilized tissue, water content below 5% w/w, pharmaceutically acceptable carriers, cellulose ethers, plasticizers, dehydrated sheets and films, defined thicknesses, defined decidua concentrations, hydrogel-forming capability upon contact with water or another aqueous medium, and optical properties. These claimed features are not attributes of or inherent to naturally occurring decidua in situ. They are engineered characteristics resulting from human processing and formulation that render the decidua tissue structurally and physically different from naturally occurring decidua tissue.”
However, examiner recognizes that dehydrated decidua tissue is different from hydrated decidua tissue in situ because there is less/no water, and a dehydrated decidua tissue might possess properties of being “stiffer’; however, the dehydrated decidua tissue is still decidua tissue that is not markedly different because there are no markedly different functional/structural changes as the dehydrated decidua tissue in all other ways is identical with the exception of having less/no water, and having less water does not alter the tissue such that it makes it patent eligible.
Applicant argues on page 7 that, “The Office does not explain why these differences are merely incidental, rather than marked. Nor does the Office identify any evidence that naturally occurring decidua in situ has the same water content, viability state, powder form, particle-size distribution, film or sheet structure, carrier composition, or hydrogel-forming viscosity behavior as the claimed compositions.”
Examiner reiterates that lyophilized tissue does not alter the decidua tissue such that it makes it patent eligible. There is no marked difference as the tissue in all other ways is identical with the exception of having less/no water.
Applicant argues on page 8 that, “The Examiner's assertion that dehydration "contains less water or no water" but does not markedly change the structure improperly minimizes the significance of water content in biological tissue. Action at 3. The question is not whether some abstract portion of tissue remains recognizable after drying. The question is whether the claimed dehydrated decidua composition has markedly different structural, physical, functional, or other properties from naturally occurring hydrated decidua in its natural state. The Specification and supporting evidence show that it does.”
However, examiner recognizes that dehydrated decidua tissue is different from hydrated decidua tissue in situ because there is less/no water, and a dehydrated decidua tissue might possess properties of being “stiffer’; however, the dehydrated decidua tissue is still decidua tissue that is not markedly different because there are no markedly different functional/structural changes as the dehydrated decidua tissue in all other ways is identical with the exception of having less/no water, and having less water does not alter the tissue such that it makes it patent eligible.
Applicant argues on pages 9-10 that the claims directed to films, sheets, carriers, and hydrogel forming behavior provide additional markedly different characteristics.
However, examiner reiterates that dehydrated decidua tissue remains the same tissue material with less/no water whether it is in the form of a sheet or thin film. Examiner maintains that the dehydrated decidua tissue is still decidua tissue that is not markedly different because there are no markedly different functional/structural changes as the dehydrated decidua tissue in all other ways is identical with the exception of having less/no water, and having less water does not alter the tissue such that it makes it patent eligible.
Conclusion
Claims 28 and 38 are allowed.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Quanglong Truong whose telephone number is 571-270-0719. The examiner can normally be reached on Monday to Friday from 8:00 am – 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QUANGLONG N TRUONG/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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