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 .
Summary
Claims 1, 4, 6, 15, 29, 33, 37, and 39-51 are pending in this office action. Claims 2-3, 5, 7-14, 16-28, 30-32, 34-36, and 38 are cancelled. All pending claims are under examination in this application.
Priority
The current application was filed on August 26, 2024 is a 371 of PCT/US2022/020336 filed on March 15, 2022.
Information Disclosure Statement
Receipt of the Information Disclosure Statements filed on February 19, 2025 and April 3, 2025 are acknowledged. A signed copy of both documents are attached to this office action.
Claim Objections
Claims 47-48 are objected to because of the following informalities:
Claim 47: Antecedent basis has already been established with “an antibiotic” in claim 46, therefore please use “said antibiotic.”
Claim 48: Antecedent basis has already been established with “a coagulant” in claim 46, therefore please use “said coagulant.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 42 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Consists essentially of is interpreted as, comprising, within claim 42. Since claim 37 comprises a mammalian albumin polypeptide and a gas, claim 42 does not further limit the claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 non-obviousness.
Claims 1, 4, 6, 15, 29, 33, 37, and 39-51 are rejected under 35 U.S.C. 103 as being unpatentable over Goessl et al. (US10,307,509B2) in view of Zugates et al. (US2014/0316367A1), Carrara et al. (J. Lab Precision Medicine, 2018) and Hu et al. (Advanced Materials, 2019).
[The Examiner is going to introduce each reference and then combine them where appropriate to reject the instant claims.]
1. Goessl et al.
Goessl et al. is the closest prior art to the present invention as it teaches a hemostatic foam (see title). Additionally, Goessl et al. disclose that the invention discloses a pharmaceutical hemostatic liquid foam base preparation comprising albumin as foaming agent and a fibrinogen precipitating substance and optionally a coagulation inducing agent, wherein albumin as foaming agent is present in native form; a method for the production of a transient hemostatic liquid foam; the transient hemostatic liquid foam; and a kit for making the foam (see abstract).
2. Zugates et al.
Zugates et al. teach foam-based medical treatments (see title). In addition, Zugates et al. disclose that the present invention relates generally to systems and methods for generating polymer foams within body cavities to locate and/or control bleeding. The present invention further relates to methods and systems for generating polymer foams within non-compressible wounds to control or stop bleeding. The present invention further relates to the use of foams and gels for medical and cosmetic purposes (see abstract).
3. Carrara et al.
Carrara et al. teach GFR measured by iohexol: the best choice from a laboratory
perspective (see title). Also, Carrara et al. disclose that to rigorously assess glomerular filtration rate (GFR), it is necessary to measure renal inulin clearance. This procedure is, however, cumbersome and difficult for routine clinical and can be replaced by determining the clearance of radiolabeled compounds or contrast media that fulfil the criteria for ideal filtration marker. The non-ionic contrast agent iohexol is the most widely used and studied alternative marker for GFR measurement. Plasma clearance is determined after intravenous administration of 5-10 mL of the pharmacological preparation and subsequent multiple sample drawings, according to different schedules or even with single specimen protocols. lohexol in biological matrices is readily determinable, with sufficient sensitivity and specificity by means of the most commonly used analytical technologies: sample preparation is fast and the compound is quite stable in biological samples, either at room temperature or, for longer-term
storage, at -20 or -80 °C. The participation of the laboratory in the international proficiency test acted by Equalis AB, Sweden, is highly recommended to ensure reliable results and enable interlaboratory comparison of the data. To improve patient comfort and reduce pre-analytical steps, simplified procedures for GFR measurement requiring only 10 μL of whole blood [dried blood spot testing (DBS)] are valid alternatives to
plasma clearance and require minimal analytical method modification for analysis. Iohexol administration for GFR measurement is a safe procedure, even in repeated investigations in the same subject, with no occurrence of major or sever adverse events. Plasma clearance of iohexol for renal function determination has a number of advantages: it is a cheap, very simple approach that is not technically demanding and is easy to implement in every centre. The choice of iohexol offers both laboratorians and clinicians the opportunity to easily select and adjust to the most appropriate approach for reliable and accurate GFR measurement (see abstract).
4. Hu et al.
Hu et al. teach advances in biomaterials and technologies for vascular embolization (see title). In addition, Hu et al. disclose that minimally invasive transcatheter embolization is a common nonsurgical procedure in interventional radiology used for the deliberate occlusion of blood vessels for the treatment of diseased or injured vasculature. A wide variety of embolic agents including metallic coils, calibrated microspheres, and liquids are available for clinical practice. Additionally, advances in biomaterials, such as shape-memory foams, biodegradable polymers, and in situ gelling solutions have led to the development of novel preclinical embolic agents. The aim here is to provide a comprehensive overview of current and emerging technologies in endovascular embolization with respect to devices, materials, mechanisms, and design guidelines. Limitations and challenges in embolic materials are also discussed to promote advancement in the field (see abstract).
Combination of Goessl et al. and Zugates et al.
Regarding instant claim 1, Goessl et al. and Zugates et al. teach a method of protecting tissue within a mammal. The necessary citations within Goessl et al. and Zugates et al. that pertain to instant claim 1 are presented in Table I.
Table I
Instant Claim 1
Goessl et al. and Zugates et al. Citations
A method for protecting tissue within a mammal, said method comprising: administering to said mammal a foam composition comprising a mammalian albumin polypeptide and a gas,
Goessl et al. disclose a foam composition comprising a mammalian albumin polypeptide and a gas [hemostatic foam comprising foaming agent in the form of human albumin and foaming gas; see column 1, lines 40-50; column 3, lines 15-20; claim 1 of Goessl et al.; also see Example 1 “pig” (mammal) within Goessl et al.]. Goessl et al. provides a pharmaceutical hemostatic liquid foam base preparation comprising albumin as foaming agent and a fibrinogen precipitating substance and optionally a coagulation inducing agent, wherein albumin as foaming agent is present in native form. With the foam base of Goessl et al., improved hemostatic foams are provided which can be safely injected into tissue voids with low visibility and which are effective with no need for approximation. No excessive swelling or obstruction risks are obtained with the foams according to the present invention. Moreover, the foam according to the present invention is specifically suitable in neuro/spine, laparoscopic and cardiovascular surgery (see column 2, lines 51-63 within Goessl et al.).
Goessl et al. does not specifically disclose the protection of tissue or the physical separation of target and non-target tissue. However, Zugates et al. addresses this in full.
Zugates et al. disclose a method for protecting tissue within a mammal (delivering a foam for displacement of tissues or organs to prevent damage during cryoablation or thermal ablation of a patient; see paragraphs [0055] and [0059] within Zugates et al.), said method comprising: administering to said mammal a foam composition (the foam is injected to dispIace the tissues or organs of the patient; see paragraphs [0055] and [0059] within Zugates et al.).
wherein said administering comprises injecting an amount of said foam composition into said mammal at a site between a target tissue and a non-target tissue, such that said foam physically separates said target tissue from said non-target tissue,
wherein said administering comprises injecting an amount of said foam composition into said mammal at a site between a target tissue and a non-target tissue (the foam is injected via an applicator or catheter to the desired location into the body of the patient using a syringe, catheter, or relative device; see paragraphs [0055] and [0059] within Zugates et al.), such that said foam physically separates said target tissue from said non-target tissue, and subjecting said mammal to an ablation procedure directed to said target tissue.
and subjecting said mammal to an ablation procedure directed to said target tissue,
wherein said foam protects said non-target tissue from damage by said ablation procedure (the foam is injected for displacement of tissues or organs (non-target tissue) to prevent damage during cryoablation or thermal ablation, therefore the foam separates the target tissue that is being ablated from the tissue or organs that are being protected (see paragraphs [0055] and [0059] within Zugates et al.).
wherein said foam protects said non-target tissue from damage by said ablation procedure.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Goessl et al. with the teachings of Zugates et al. The foam composition of Goessl et al. comprising the albumin and foaming gas can be injected into tissue voids with low visibility, is effective with no need for approximation, does not present a risk of obstruction or compression of pressure sensitive organs or tissues due to excessive swelling, and is specifically applicable in surgeries (see Goessl et al.; column 1, lines 40-50), and therefore would make an excellent foam for gently displacing organs without damaging them. The Zugates et al. reference supplies the specifics regarding tissue protection and displacement (see Table I above). The motivation to combine the two references would be to create foam composition comprising a mammalian albumin polypeptide and a gas, which delivers tissue protection and displacement within a subject.
Regarding instant claims 4, 40, and 41, Goessl et al. and Zugates et al. teach wherein said gas is air or carbon dioxide.
Goessl et al. disclose wherein the foaming gas is selected from the group consisting of air, N2, O2, N2O, CO2, propane, butane, dimethylether, or partly fluorinated hydrocarbons (HFCs) (see claim 4 within Gossel et al.).
Regarding instant claims 6 and 43, Goessl et al. and Zugates et al. teach wherein said foam composition further comprises an additive.
Goessl et al. disclose the optionally a coagulation inducing agent (as an additive; see column 2, line 54 within Goessl et al.).
Combination of Goessl et al., Zugates et al., and Hu et al.
Regarding instant claim 15, Goessl et al., Zugates et al., and Hu et al. teach a method for embolizing a blood vessel, said method comprising injecting into said blood vessel an amount of a foam composition effective to embolize said blood vessel, wherein said foam comprises a mammalian albumin polypeptide and a gas.
Hu et al. disclose a review on embolization on different biomaterials such as a foam (see title and abstract within Hu et al.). Embolization is defined as a decrease in blood flow to a part of the body (embolization; see page 1, right column, 1st paragraph within Hu et al.), and thus embolization is related to thrombosis.
Zugates et al. disclose that additionally, hydride functional (Si—H) siloxanes or isocyanate functionalized carbinols can be introduced into silanol elastomer formulations to generate gas and produce expanding foamed structures. Expansion of the material increases the size of the formed coil, thereby effectively decreasing the embolization potential of the coil. Expansion can also increase the size of the material thereby adding porosity and generating sealing pressure without requiring the delivery of additional material. Additional formulation ingredients such as surfactants may be used to alter the impact of generated gas on porosity and expansion (see paragraph [0029] within Zugates et al.). Since both Goessl et al. (coagulants; see instant claim 6 and 43) and Zugates et al. (blood flow; see paragraphs [0005-0007] within Zugates et al.) are concerned with overall blood flow to a wound site it would make perfect sense to a skilled artisan (POSITA; person of ordinary skill in the art) to decrease the blood flow by embolizing a blood vessel using the composition taught within instant claim 1.
Additionally, please see the discussion and citations within instant claim 1 for the relevant rejection text.
Combination of Goessl et al. and Zugates et al.
Regarding instant claim 29, Goessl et al. and Zugates et al. teach a method for inducing thrombosis at a biopsy site in a tissue of a mammal, said method comprising:
obtaining a tissue sample from a selected location in said mammal, and
administering to said mammal a foam composition comprising a mammalian albumin polypeptide, thrombin, and a gas, wherein said administering comprises injecting an amount of said foam composition into said mammal at said selected location, wherein said foam induces thrombosis at said selected location.
Goessl et al. disclose the use of a coagulation agent (see column 4, lines 32-47 within Goessl et al.; also see instant 6 and 43). Furthermore, please see the discussion and citations within instant claim 1 for the relevant rejection text. Goessl et al. fails to mention inducing thrombosis at a biopsy site. However, this would be within the scope of a skilled artisan (POSITA) to employ the composition taught by Goessl et al. and Zugates et al. to induce thrombosis at a biopsy site in a tissue of a mammal following the instant claim 29 protocol.
Regarding instant claim 33, Goessl et al. and Zugates et al. teach a method for inducing thrombosis in a blood vessel of a mammal, said method comprising injecting into said blood vessel of said mammal a foam composition comprising a mammalian albumin polypeptide, thrombin, and a gas, wherein said injected foam induces thrombosis in said blood vessel.
Please see the discussion and citations within instant claims 29 and 1 for the relevant rejection text. A skilled artisan (POSITA) to employ the composition taught by Goessl et al. and Zugates et al. to induce thrombosis at a blood vessel of a mammal following the instant claim 33 protocol.
Regarding instant claim 37, Goessl et al. and Zugates et al. teach a foam composition comprising a mammalian albumin polypeptide and a gas, wherein said composition has a stability of at least 50% after 30 minutes in vivo.
Goessl et al. disclose that such foams were observed to be stable over 10 min and could be further applied through an application tip the same as it is used in Floseal Hemostatic Matrix (see column 11, lines 31-34 within Goessl et al.). Despite the fact that testing was not carried out to 30 minutes in vivo, there is no reason to believe the foam of Goessl et al. will be less than 50% stable at that time.
Regarding instant claim 39, Goessl et al. and Zugates et al. teach wherein said albumin polypeptide is a human albumin polypeptide.
Goessl et al. disclose that preferably, the albumin used is an albumin which is pharmaceutically acceptable, especially human albumin from human blood plasma or recombinant human protein (see column 3, lines 16-18 within Goessl et al.).
Regarding instant claim 42, Goessl et al. and Zugates et al. teach wherein said foam composition consists essentially of said mammalian albumin polypeptide and said gas.
Please see the discussion and citations within instant claim 1 for the relevant rejection text.
Regarding instant claims 44-46, Goessl et al. and Zugates et al. teach wherein said additive is protamine, lidocaine, an antibiotic, or a coagulant.
Zugates et al. disclose that in yet another embodiment, pain relieving agents such as bupivacaine, lidocaine, ropivacaine, morphine or peptides may be incorporated into or onto the foam or bag. In yet another embodiment, disinfectants, antimicrobials, antibiotics or antifungals, such as iodine, iodine precursors or silver ions, may be incorporated into or onto the foam or bag. The agents listed above may be combined on one device to provide multi-functionality and may be formulated to provide a controlled or sustained release (e.g., polymer coatings, polymer fibers, core-sheath fibers and microspheres) (see paragraph [0084] within Zugates et al.). Furthermore, Goessl et al. disclose the use of a coagulant (see instant claim 6 and 43). a skilled artisan (POSITA) to employ the composition taught by Goessl et al. and Zugates et al. to incorporate the appropriate additive.
Regarding instant claim 47, Goessl et al. and Zugates et al. teach wherein said therapeutic agent is a specific group of antibiotics.
Although a specific group of antibiotics is not mentioned within Zugates et al. it would be within the scope of a skilled artisan (POSITA) to select from common groups of antibiotics listed within the instant claim 47 limitation.
Regarding instant claim 48, Goessl et al. and Zugates et al. teach wherein said therapeutic agent is a coagulant selected from the group consisting of thrombin, clotting factors of the coagulation cascade, zinc, and antifibrinolytic drugs.
Goessl et al. disclose the use of the coagulant thrombin (see instant claim 6 and 43).
Regarding instant claims 49-50, Goessl et al. and Zugates et al. teach wherein said additive is an iodine-based contrast agent.
Zugates et al. disclose that additionally, any of the foams (or gels) of the present invention may be further formulated to be radiopaque, fluorescent, or otherwise visible by imaging techniques known to those skilled in the art. For example, radio-opacity may be imparted by incorporation of iodinated contrast materials, barium sulfate, metal particles such … (see paragraph [0031] within Zugates et al.).
Combination of Goessl et al., Zugates et al., and Carrara et al.
Regarding instant claim 51, Goessl et al., Zugates et al., and Carrara et al. teach wherein said iodine-based contrast agent is iohexol.
Zugates et al. disclose the use of iodinated contrast materials (see instant claim 50). Carrara et al. disclose the use of the iodine-based contrast agent, iohexol (see title and abstract within Carrara et al.). Therefore, a skilled artisan (POSITA) could substitute in iohexol for the iodinated contrast materials under routine experimental conditions.
Analogous Art
The Goessl et al., Zugates et al., Carrara et al., and Hu et al. references are directed to the same field of endeavor as the instant claims, that is, a method of protecting tissue within a mammal, as disclosed within instant claim 1.
Obviousness Analysis
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the hemostatic foam composition disclosed by Goessl et al., using the teachings of Zugates et al., Carrara et al., and Hu et al. in order to arrive at the subject matter of the instant claims.
The Goessl et al., Zugates et al., Carrara et al., and Hu et al. references all have considerable overlap in the foam medical treatment arts. In this instance, Goessl et al. supplies the template for the hemostatic foam composition, Zugates et al. supplies the support for foam-based medical treatments that adjust blood flow to the site in question, while Carrara et al. and Hu et al. offer support for both the iodinated-contrast agent iohexol and biomaterials used in embolization procedures, respectively. All references are directed to medical treatments and therefore constitute analogous art under MPEP §2141.01(a). A POSITA would have reasonably consulted the four references when seeking to develop a method protecting tissue within a mammal using a foam-based biomaterial.
Given these teachings, a POSITA would have been motivated to combine the template for the hemostatic foam as disclosed by Goessl et al., support for foam-based medical treatments that adjust blood flow to the site in question disclosed by Zugates et al., and the support for both the iodinated-contrast agent iohexol and biomaterials used in embolization procedures by Carrara et al. and Hu et al., respectively.
The modification constitutes a simple substitution of one known element for another to obtain a predictable result [MPEP §2143(I)(B)].
The combination represents the use of a known technique to improve a similar composition in the same way [MPEP §2143(I)(C)].
The art provides a finite number of identified, predictable solutions, and the POSITA would have pursued the claimed configuration with a reasonable expectation of success [MPEP §2143(I)(E); KSR].
The combination of the hemostatic foam composition taught by Goessl et al. along with the use of the necessary claim limitations taught by Zugates et al., Carrara et al., and Hu et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application.
Furthermore, the additional claim limitations taught by Zugates et al., Carrara et al., and Hu et al. would have been viewed by a POSITA as routine design optimizations or known modifications for the modification of foam-based medical treatments. The motivation to combine the four references would be to create foam composition comprising a mammalian albumin polypeptide and a gas, which delivers tissue protection and displacement within a subject, and comprises the appropriate additive. Implementing these features in Goessl et al.’s hemostatic foam composition would not require more than ordinary skill or routine experimentation.
Accordingly, the combination of Goessl et al., Zugates et al., Carrara et al., and Hu et al. provides all the elements of the claimed invention. The resulting method of protecting tissue within a mammal using a foam-based biomaterial, constitutes no more than the predictable outcome of combining familiar prior art components, and therefore the claimed subject matter would have been obvious to a POSITA prior to the effective filing date of the invention.
Conclusion
No claims are allowed.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
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