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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 11/03/2025 is acknowledged.
Claims 12-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/03/2025.
Claims 1-11 and 18-19 are being examined on the merits.
Claim Objections
Claim 8 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claim 4 has not been further treated 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 1 is 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. The claims 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 8-10 are also confusing because claim 8 recites “wherein the polyphenol is of plant origin, which may comprise fruit, nut, vegetable or spice” and polyphenols do not comprise of any of these components. If the applicant is requiring that the polyphenol comes from a nut, fruit, vegetable of spice, it is suggested to better word the claim to recite such a limitation.
Claim 10 is indefinite for reciting the term “preferably”. It is not clear if the phrasing after the term “preferably” is meant to further limit the claim or is merely suggestive in nature.
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 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)).
Since the naturally-occurring components as-claimed are not found together in nature, admixing the ingredients into a single formulation is considered an ‘additional element’ which must be analyzed for eligibility. Admixing naturally-occurring plant extracts is well-understood, routine practice in the art and has been conducted for centuries. Admixing animal/plant components for creating hydrogels is also well-understood, routine, ordinary practice in the field as evidenced by at least the following documents: US 4583320 A, US 4769945 A, US 5093130 A, US 6319510 B1 and US 20020048603 A1.
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.
Therefore, admixing the claimed naturally-occurring ingredients at such a high degree of generality merely involves applying the natural principal and appears to be no more than a drafting effort to claim the judicial exception itself; a mixture of naturally-occurring components that is not markedly different from its’ closest-occurring natural counterpart and which does not offer significantly more than the judicial exception.
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.
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.
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.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655