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 and the species degradable by amylase in the reply filed on 10/01/2025 is acknowledged. There was a discrepancy with the election as the applicant elected Group I but stated that they wanted the composition examined. Group I is a method. I called and spoke with the applicant (Sulay Jhaveri) on 10/22/2025 to clarify the election and Group I is to be examined which is to the method of delivering a biological material to a wounded tissue of a patient.
Claims 21-24 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 10/01/2025.
Claims 1-20 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.
Claim 12 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 claim recites components “a. a powder; or b. a gel, putty, or paste” and it is unclear if the a. and b. of claim 12 are directed to the a. and b. of claim 1 or if the applicant is merely giving options for the starch particles. This is indefinite and confusing. If the applicant is merely giving options for the starch, then there is no reason to claim them as a. and b. and should just list the options to make the claim more clearly understood.
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 1-8, 12-13, 15, 17 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xin Ji et. al. (US20090062233A1).
Regarding claims 1, 15, 17, 20, Ji discloses a method of treating a wounded tissue of an animal which comprises applying a biocompatible modified starch to the tissue and wherein the modified starch has a molecular weight of 15,000 daltons or more and a grain diameter or 1 to 1000 um (see claim 1 and abstract). Ji discloses wherein the modified starch is carboxymethyl starch or hydroxyethyl starch (see claims 16-17) and this would act as the carboxylation or hydroxylation of glucose units in the starch as claimed. This process of applying the biocompatible modified starch and the biological material which would be the wounded tissue would be the same as combining to form a mixture as claimed. Additionally, the carboxymethyl starch is degradable by amylase.
Regarding claims 2-3, 6 and 15, Ji discloses according to the present invention, by adding the functional group on the raw starch glucose units with chemical agents, e.g. by carboxylation modification, or hydroxylation modification, the starch captures hydrophilic groups in its molecular structure and obtains hydrophilic properties. By using bifunctional or polyfunctional chemical agents to cross-link the raw starch macromolecules or grafting external macromolecular hydrophilic groups to the raw starch, the starch acquires enhanced hydrophilic properties and viscosity/adhesiveness in a water solution. The viscosity of modified starch relates to the raw starch origin and the degree of substitution of external and the cross-linked or grafted functional groups, etc. When contacting blood, the hydrophic and adhesive properties of the prescribed modified starch will produce a “starch-blood coagulation matrix” with strong adhesive characteristics which can seal wounded tissue and stop bleeding. In addition, the interaction between the formed blood coagulation matrix and the functional groups of tissue proteins will cause the “starch-blood coagulation matrix” to adhere to and seal the wounded tissue, resulting in hemostasis” (see 0127). This describes wherein the biological material is both a biological fluid and blood. This describes wherein the biological material is both a biological fluid and blood. It is also presumed to that the tissues are autogenic as the methods describe treating the patient with the modified starch and is directed to their own tissues (blood, plasma, etc). Additionally, the carboxymethyl starch is degradable by amylase.
Regarding claim 4, Ji discloses the modified starch interacting with both blood and plasma (see at least 0119) and this would be at least one or more tissue fragments.
Regarding claim 7, Ji discloses “the modified starch hemostatic composition, according to the present invention, can be applied for hemostasis on bleeding bone tissue caused by surgery or trauma, particularly for hemostasis in spongy bone tissue” (See 0071) and surgery would create bone dust as claimed.
Regarding claim 8, Ji discloses “the mechanism for promoting tissue healing is the “glue” formation after modified starch contacts blood and establishes the “scaffold” on the wound surface which facilitates the adherence, growth, connection and propagation of tissue cells such as osteoblasts or fibroblasts. In addition, local blood platelets are increasingly concentrated on the wound and, when activated, release tissue factors which promote healing” (see 0170). Thus the mixture would also comprise of the cytokines and growth factors and viable cells as claimed.
Regarding claim 12, Ji discloses that the modified starch can be made into a hemostatic powder or gel (see 0176).
Regarding claim 13, Ji discloses wherein the method was done with animals who underwent cranial surgery (see 0274).
Regarding claim 17 and 19, Ji discloses wherein anti-inflammatory and antibiotics can be added (see 0075).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Xin Ji et. al. (US20090062233A1).
Regarding claims 1, 15, 17, 20, Ji discloses a method of treating a wounded tissue of an animal which comprises applying a biocompatible modified starch to the tissue and wherein the modified starch has a molecular weight of 15,000 daltons or more and a grain diameter or 1 to 1000 um (see claim 1 and abstract). Ji discloses wherein the modified starch is carboxymethyl starch or hydroxyethyl starch (see claims 16-17) and this would act as the carboxylation or hydroxylation of glucose units in the starch as claimed. This process of applying the biocompatible modified starch and the biological material which would be the wounded tissue would be the same as combining to form a mixture as claimed.
Regarding claims 2-3, 6 and 15, Ji discloses according to the present invention, by adding the functional group on the raw starch glucose units with chemical agents, e.g. by carboxylation modification, or hydroxylation modification, the starch captures hydrophilic groups in its molecular structure and obtains hydrophilic properties. By using bifunctional or polyfunctional chemical agents to cross-link the raw starch macromolecules or grafting external macromolecular hydrophilic groups to the raw starch, the starch acquires enhanced hydrophilic properties and viscosity/adhesiveness in a water solution. The viscosity of modified starch relates to the raw starch origin and the degree of substitution of external and the cross-linked or grafted functional groups, etc. When contacting blood, the hydrophic and adhesive properties of the prescribed modified starch will produce a “starch-blood coagulation matrix” with strong adhesive characteristics which can seal wounded tissue and stop bleeding. In addition, the interaction between the formed blood coagulation matrix and the functional groups of tissue proteins will cause the “starch-blood coagulation matrix” to adhere to and seal the wounded tissue, resulting in hemostasis” (see 0127). This describes wherein the biological material is both a biological fluid and blood. It is also presumed to that the tissues are autogenic as the methods describe treating the patient with the modified starch and is directed to their own tissues (blood, plasma, etc).
Regarding claim 4, Ji discloses the modified starch interacting with both blood and plasma (see at least 0119) and this would be at least one or more tissue fragments.
Regarding claim 7, Ji discloses “the modified starch hemostatic composition, according to the present invention, can be applied for hemostasis on bleeding bone tissue caused by surgery or trauma, particularly for hemostasis in spongy bone tissue” (See 0071) and surgery on bone tissue would create bone dust as claimed.
Regarding claim 8, Ji discloses “the mechanism for promoting tissue healing is the “glue” formation after modified starch contacts blood and establishes the “scaffold” on the wound surface which facilitates the adherence, growth, connection and propagation of tissue cells such as osteoblasts or fibroblasts. In addition, local blood platelets are increasingly concentrated on the wound and, when activated, release tissue factors which promote healing” (see 0170). Thus the mixture would also comprise of the cytokines and growth factors and viable cells as claimed.
Regarding claims 9-10, Ji teaches wherein the viscosity is not lower than 30 mPas under 37 degrees Celsius (see claim 49 and 51) and teaches “grafted starch has both enhanced water absorption capability and high viscosity/adhesiveness. Therefore, it has a profound effect on hemostasis when applied to wound surfaces, especially combat wounds, traumatic wounds, and profuse bleeding from large arteries and large veins due to aneurysms or large phlebangioma ruptures” (see 0056). Additionally, “the viscosity of modified starch relates to the raw starch origin and the degree of substitution of external and the cross-linked or grafted functional groups, etc.” (see 0127).
Regarding claims 11 and 16, Ji teaches wherein the “weight proportion between the biocompatible modified starch and other biocompatible hemostatic materials can be 99.9:0.1˜1:99” (see 0155).
Regarding claim 12, Ji discloses that the modified starch can be made into a hemostatic powder or gel (see 0176).
Regarding claim 13, Ji discloses wherein the method was done with animals who underwent cranial surgery (see 0274).
Regarding claim 17 and 19, Ji discloses wherein anti-inflammatory and antibiotics can be added (see 0075).
Therefore it would have been obvious to persons having ordinary skill in the art and before the effective filing date to optimize the ratio of the modified starch to biological material (liquid) to be that within the instantly claimed range because one would want to make sure that there was enough to stop the bleeding and control for homeostasis. It would have also been obvious to optimize the viscosity to be at the instantly claimed amount because Ji teaches amounts which should at least be 30 mPa’s, which also does not describe an upper limit and so optimizing to 50 mPa’s would have been prima facie obvious. Additionally, Ji teaches the viscosity of modified starch relates to the raw starch origin and the degree of substitution of external and the cross-linked or grafted functional groups, and so using the same starch as claimed would be expected to have the same viscosity as claimed. It would have been obvious to use an allogenic biological material such as blood from another person as blood transfusions are common during surgical procedures.
Given the prior art there would have been a reasonable expectation of success in arriving at the instant invention.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Xin Ji et. al. (US20090062233A1) as applied to claims 1-17 and 19-20 above, and further in view of Jose Engelmayer and Atul Varadhachary (US20120010150A1).
Ji teaches the method of delivering a biological material to a wounded tissue of a patient as instantly claimed however is silent on the bioactive agents being lactoferrin.
Engelmayer’s disclosure is to the use of lactoferrin compositions in wound healing (see abstract).
Engelmayer teaches “a method comprising the step of administering lactoferrin to a subject having a skin wound selected from the group consisting of a chronic ulcer, a laceration, a penetrating wound, a surgical wound or an open full thickness skin puncture wound to result in improved wound closure” (see claim 1).
“Lactoferrin is an immunomodulatory human protein expressed throughout the body and found in highest concentrations in milk and colostrums. Recombinant human lactoferrin (RhLF) is a recombinant glycoprotein produced in Aspergillus niger (A. niger), a filamentous fungi. RhLF is structurally identical in all material respects to native lactoferrin and has a wide array of functions related to host defense mechanisms. For example, lactoferrin has been reported to activate natural killer (NK) cells, induce colony stimulating activity, activate polymorphonuclear neutrophils (PMN), regulate granulopoeisis, enhance antibody-dependent cell cytotoxicity, stimulate lymphokine-activated killer (LAK) cell activity, and potentiate macrophage toxicity” (see 0004).
Therefore it would have been obvious to persons having ordinary skill in the art and before the effective filing date to include lactoferrin in the method taught by Li, because as Engelmayer teaches this immunomodulating human protein cam activate human NK cells and enhance antibody-dependent cell cytotoxicity while stimulating lymphokine-activated killer (LAK) cell activity, and potentiate macrophage toxicity. Engelmayer teaches that this is useful for surgical wounds and thus including this in with Li’s invention is made obvious for the reasons just described.
Conclusion
Currently no claims are allowed.
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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JACOB A BOECKELMANExaminer, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655