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 .
Response to Amendment
Applicant's amendment and argument filed 05/11/2026 in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-19 are pending of which claims 12-17 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on
Claims 1-11 and 18-19 are being examined on the merits.
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 3, 4, 7, 10 and 18-19 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. Claims 18 and 19 do not use proper claim language and so it cannot be determined what the metes and bounds of each claim would be. The claims should recite “comprising of”, “comprising essentially of”, “consisting of” or “consisting essentially of” which would direct readers to what can and cannot be interpreted as being included in each claim. The metes and bounds and scope of the claims currently are indefinite and confusing.
Claims 3, 4, and 7 are rejected because they recite Markush claim language that is ambiguous. The claims recite “selected from the group comprising” and comprising is open ended claim language which makes the grouping indefinite because it is unclear if the group can be expanded to include other additional components outside of the Markush group.
Claim 10, recites the term “preferably” and it is unclear whether the limitations coming after the phrasing is merely suggestive or required. All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
Claim Rejections - 35 USC § 101
Claims 1-11 and 18-19 are rejected under 35 U.S.C. 101 because the claimed composition is directed to a product of nature without significantly more. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since the claim is directed to a composition comprising extracellular components of plants and animals the claim is a composition of matter. Step 2A prong one of the analyses evaluates whether the claim is a judicial exception (see MPEP 2106.04). Because the claim states the nature-based products decellularized tissue and polyphenols, flavonoids, tannins, the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within animals and plants. Animal and plant extracts are made by partitioning the starting material into separate compositions based upon some property such as solubility in a solvent, with the soluble compounds being in one composition and the insoluble being in another composition, which compositions are then generally separated into the solvent extract of that animal/plant versus the insoluble material composition that is generally discarded. Each composition has a different subset of the compounds originally present in the plant material. Those extracts are purified by removing unwanted material from the remaining solvents. The closest naturally occurring counterparts of extracts are the same compounds found within the extract that are found in the animal/plant in an unseparated form, even when purified, which is chemically identical to the extracted compounds. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found within the animal/plants they come from. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
Step 2A prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. This judicial exception is not integrated into a practical application because the applicant is only claiming different judicial exceptions combined together in a composition and doing so would be implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these components and their activity are already found naturally occurring in nature and the addition of an intended use does not impart any added benefit to the compounds or integrate the composition into a practical application.
Step 2 B evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05(b)).
The claims written with such broad scope can simply read on gut components of an animal. For instance, the gut can destroy cells through enzymes and hydrochloric acid thus creating decellularized tissues. Hydrogels naturally exist lining the gut mucous membranes and can also be formed through various components being consumed such as natural fibers like chia seeds, flax, oats etc. which would also contain polyphenols. These claims as broad as they are can read on the decellularized tissues of plants inside of your gut after one has eaten any of these natural fibers containing polyphenols.
The only other considerations are the origin from where the specific plant and animal components come from such as further limiting the type of plant and fruit to tea and grape and limiting the organ from which the tissue comes from such as bone, liver amniotic tissue etc.
Please also note, the mere modifying the concentration and proportions of the product/composition is not sufficient to remove the claimed composition from a judicial exception.
Response to Arguments
Applicant's arguments filed 05/11/2026 have been fully considered but they are not persuasive. The applicant argues that the decellularized tissue hydrogel with polyphenol significantly enhances mechanical strength and imparts flexibility, compressibility and has the ability to be rolled into structural forms. The applicant argues that these are properties not found naturally existing in unmodified ECM. The closest naturally existing components which are being examined and compared is not ECM as being argued. It is any decellularized tissue and polyphenol as so broadly claimed in hydrogel formation which can be the contents of the gut of a human after they have eaten chia seeds, flax seeds, oats, etc., and which contain polyphenols and would form hydrogel crosslinks in the gut. When you eat soluble fibers—such as chia seeds, flaxseeds, oats, they absorb water and turn into a gel-like consistency in the digestive tract. Polyphenols possess abundant hydroxyl groups and naturally form reversible bonds (like hydrogen bonds) with the polymer networks of hydrogels.
The applicant argues that the properties from the hydrogel are formed because of human engineering and which alters the materials chemical structures. The fact that humans can engineer a hydrogel does not overcome the rejections because the applicant is claiming much more broadly than what they argue. The applicant is advised to narrow the claims scope and/or formulations to be more commensurate with the invention. As so broadly claimed they do not overcome the 101 rejection.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1-2 and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang Liang et. al. (From IDS, CN109481737B).
Regarding claims 1, 9 and 11 Wang describes a decellularized tissue hydrogel cross-linked with a polyphenol. Wang discloses “the invention provides a bionic double-layer dressing, which comprises a small intestine submucosa of a decellularized animal and a gel layer crosslinked on a film layer, wherein the film layer and the gel layer jointly form the bionic double-layer dressing with a double-layer structure” (see abstract) and discloses cross-linking solution is glutaraldehyde or a mixed solution of tea polyphenol (see para. 6, page 8 or claims 2 and 4).
Regarding claim 2, Wang discloses wherein the tissue is bone (see design of experiments, page 13).
Regarding claims 18-19, the limitations “for use in the treatment of a wound, condition or injury” and “wherein the wound, condition or injury comprises a wound, condition or injury to bone, nerves, tendons or abdominal regions” are intended uses. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case the prior art structure is capable of performing the intended use.
Response to Arguments
Applicant's arguments filed 05/11/2026 have been fully considered but they are not persuasive. The applicant argues that Liang does not disclose a decellularized tissue because decellularized tissue hydrogels are well known in the art. The applicant then points to an article; however these articles are not taken-into-consideration because they were not properly submitted for the examiner to read and was not included in an IDS as required by the MPEP. Additionally, there is no definition of what the decellularized tissue must be in the specifications and with the broadest reasonable interpretation Linag indeed teaches decellularized tissues crosslinked with film layers and gel layers mixed with tea polyphenols.
The applicant argues that Jiang does not teach a decellularized tissue being digested and then neutralized to form a decellularized tissue hydrogel. These limitations are not claimed and thus do not need to be met.
Claims 1, 3-8, 11 and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chang Jiang et. al. (CN102836464B).
Regarding claims 1,3-8 and 11, Jiang teaches discloses a step of crosslinking the natural extracellular matrix of vessels by using procyanidins (see abstract). This would read on each claim because procyanidins are flavonoids, condensed tannins, proanthocyanidins and come from fruits.
Regarding claims 18-19, the limitations “for use in the treatment of a wound, condition or injury” and “wherein the wound, condition or injury comprises a wound, condition or injury to bone, nerves, tendons or abdominal regions” are intended uses. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case the prior art structure is capable of performing the intended use.
Response to Arguments
Applicant's arguments filed 05/11/2026 have been fully considered but they are not persuasive. The applicant argues that Jian does not disclose decellularized tissue hydrogels or crosslinking polyphenols and then argues what Jiang teaches which is to cross-linking natural ECM of blood vessel with proanthocyanidins for increasing mechanical strength and stability etc. The applicant has not made any point against why they believe Jiang does not teach the instant invention.
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 (i.e., changing from AIA to pre-AIA ) 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, 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.
Claims 1, 3-8, 10 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Chang Jiang et. al. (CN102836464B).
Jiang teaches discloses a step of crosslinking the natural extracellular matrix of vessels by using procyanidins (see abstract).
Regarding claims 1 and 3-8, Jiang teaches discloses a step of crosslinking the natural extracellular matrix of vessels by using procyanidins (see abstract). This would read on each claim because procyanidins are flavonoids, condensed tannins, proanthocyanidins and come from fruits.
Regarding claim 10, Jiang teaches wherein the proanthocyanidins were originally extracted from the bark of the coastal pine (Pinus maritina) along the Mediterranean coast, and now it can be extracted in large quantities from fruits such as grapes Fructus Vitis viniferae, (see bottom of page 6 and top of page 7).
Regarding claims 18-19, the limitations “for use in the treatment of a wound, condition or injury” and “wherein the wound, condition or injury comprises a wound, condition or injury to bone, nerves, tendons or abdominal regions” are intended uses. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case the prior art structure is capable of performing the intended use.
Therefore it would have been obvious to persons having skill in the art before the effective filing date to use proanthocyanidins from grapes because Jiang teaches wherein these can be extracted in large quantities.
Response to Arguments
Applicant's arguments filed 05/11/2026 have been fully considered but they are not persuasive. The applicant argues that Jiang’s invention would not provide the advantages which they believe are excellent mechanical strength, flexibility, compressibility and rollability of the instant invention. Jiang’s invention does not need to provide the same argued features as these are not limitations of the invention. Jiang indeed teaches a composition to have cross-linking natural ECM (decellularized) ability of blood vessel with proanthocyanidins for increasing mechanical strength and stability. The applicant just argued that Jiang teaches these features and recognizes that Jiang’s invention has improved strength and stability. Jiang teaches “these studies suggest that if the decellularized tissue material can be completely decellularized, the tensile strength of the decellularized tissue material can be improved, the flexibility can be maintained, the elasticity can be maintained properly, the calcification can be inhibited, and the platelet aggregation can be inhibited to prevent thrombosis, then the resulting blood vessel will be ideal. Treatment of decellularized vascular tissue with cross-linking agent is an effective method to improve its mechanical and biological properties” (see Jiang and applicant’s arguments at page 7).
Conclusion
Currently no claims allowed.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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