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 .
DETAILED ACTION
Claims 20-43 are pending and a preliminary amendment to the claims filed 09/30/2024 is acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/17/2024 was filed before the mailing date of the instant first action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith.
Specification
The abstract of the specification is objected to a minor informality.
Applicant is reminded of the proper content of an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. See MPEP 608.01(b)
In the instant case, the claimed invention is directed to a method, not a product. The abstract does not comply with the above guideline by having title and information of related product applications. Accordingly, appropriate correction is requested.
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 20-43 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.
Claim 20 recites "A method comprising positioning a tissue adhesive … ". However, it is not clear what a preamble part intends to. Does applicant intend to recite "A method of forming a tissue adhesive on a tissue site comprising placing a tissue adhesive? Clarification is required.
Claim 34 recites “thin film”, but it is unclear what thickness is considered “thin”. The specification does not define it in a sufficient manner. What factors should be considered “thin” varies widely in the art depending on the individual situation and the person making the determination of factors which may mainly depend on intended uses, target sites of tissue-adhesive, various ingredients of film, their amounts, etc. Appropriate and/or explanation are requested.
The remaining claims are also indefinite due to vagueness of base claim 20.
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.
Claim Rejections - 35 USC § 102
(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 20, 22 and 25-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by anticipated by Wang et al. "Feasibility of chitosan-alginate (Chi-Alg) hydrogel used as scaffold for neural tissue engineering: a pilot study in vitro," Biotechnology & Biotechnological Equipment, 2017, pp. 1-9 (IDS of 10/17/2024).
Applicant claims including the below claim 20 filed on 09/30/2024:
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Prior Art
Wang teaches a cationic polymer, chitosan has good biocompatibility, biodegradability, low toxicity and ability to be fabricated into various forms in tissue engineering, such as films, porous scaffolds, hydrogels, and tubes; and an anionic polymer, alginate is biocompatible, hydrophilic and biodegradable under normal physiological conditions and has been widely used in bone tissue engineering and drug delivery (page 766, left column). The preparation method includes chitosan-sodium alginate powders were dissolved in acetic acid and distilled water, respectively, to obtain separate solutions, and then NaCl was added into the sodium alginate solution to obtain a 1.2 mol/L concentration of NaCl, and the chitosan solution was injected dropwise into the sodium alginate solution to obtain a homogenous solution (1% chitosan and 1% alginate), and the solution pH was adjusted to pH 7.4 and then the solution was incubated for obtaining final product of chitosan-alginate hydrogel (page 767, left column: Preparation of the chitosan-alginate hydrogel) which reads on the claimed gel. Here, chitosan-sodium alginate hydrogel is in vitro contacted to neural stem cells (NSC) and olfactory ensheathing cells (OEC) that are isolated from nerve tissues such as corticies and olfactory bulbs, and the hydrogel could well promote the proliferation of nerve cells (OECs and NSCs), and thus contacting method reads on the claimed method wherein the NSCs and OECs for tissue engineering read on the claimed tissue site because the claimed tissue site does not require in-vivo tissue site; further the mixture of chitosan powders read on the instant mixture of natural polymers in the tissue adhesive; the acetic acid reads on the instant activating agent; the ratio of sodium alginate and chitosan being 1:1 is within the instant ratios of ‘between 10:90 and 90:10’, and ‘between 25:75 and 75:25’; and chitosan-alginate hydrogel reads on the instant tissue adhesive in the form of gel (instant claims 20, 22 and 25-33).
In light of the foregoing, instant claims 20, 22 and 25-33 are anticipated by Wang.
Claim Rejections - 35 USC § 103
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 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 20, 22 and 25-43 are rejected under 35 USC 103 as being obvious over Wang et al. “Feasibility of chitosan-alginate (Chi-Alg) hydrogel used as scaffold for neural tissue engineering: a pilot study in vitro,” Biotechnology & Biotechnological Equipment, 2017, pp. 1-9 (IDS of 10/14/2024, as applied to instant claims 20, 22 and 25-33) in view of Tijsma et al. (US2009/0291912A1, IDS of 10/14/2024) and Bianco-Peled et al. (US2011/0015759A1, IDS of 10/14/2024).
Applicant claims as noted above:
Level of Ordinary Skill in the Art
(MPEP 2141.03)
The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The examiner must ascertain what would have been obvious to one of ordinary skill in the art at the time the invention was made, and not to the inventor, a judge, a layman, those skilled in remote arts, or to geniuses in the art at hand. Environmental Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 218 USPQ 865 (Fed. Cir. 1983), cert. denied, 464 U.S. 1043 (1984).
The level of ordinary skill will often predetermine whether an implicit suggestion exists to modify the prior art. Persons of varying degrees of skill not only possess varying bases of knowledge, they also possess varying levels of imagination and ingenuity in the relevant field, particularly with respect to problem-solving abilities. If the level of skill is low, for example that of a mere technician, then it may be rational to assume that such an artisan would not think to combine references absent explicit direction in a prior art reference. If, however, the level of skill is that of relevant research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from pharmacy, physiology and chemistry— without being told to do so.
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02); Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Wang was discussed above with respect to instant claims 20, 22 and 25-33.
However, Wang does not expressly teach various tissue sites of instant claim 21; thin film of instant claim 34; additional therapeutic agent of instant claims 35-36; and aqueous solution of starch of instant claims 42-43. The deficiencies are cured by Tijsma.
Tijsma teaches a method for treating body tissue comprising filling a two-part composition into the treatment site wherein the two- part composition comprises a first part of natural polymer includes polysaccharides, hydrolysis derivatives thereof or its salts such as chitosan and its salts, alginate, carrageenans, chondroitin, hyaluronic acid … and mixtures thereof (elected species of chitosan and alginate) and a second part of crosslinkers include aqueous solution of water soluble starch or oxidized starch to form a gel and the gel forms a protective layer of thin film. Please note that “toughening treatment of an adhesive gel is intended to mean a chemical cross-linking that allows the gel to retain firmness and/or integrity or reduce fluid absorption when exposed to bodily fluids” as defined by the instant publication at [0063] and therefore, claim 76 would be implicit that after filling the two-part composition into the target tissue site, a surface of the gel would be toughened to increase durability and decrease fluid adsorption, devoid of evidence to the contrary, and consequently Tijsma teaches crosslinking with crosslinker reads on the claimed toughening treatment; and the composition further comprises therapeutic agents, antimicrobial agents, analgesics, vasoconstrictors (e.g., [0070]-[0071]); acids such as sodium acetic acid, sodium citric acid, sodium phosphoric acid which has carboxylic acid in the molecules, solvents, buffers, , etc. (e.g., [0069]), and the treatment site includes skin and surgically repaired tissue, cartilage, bone, nasal sinus cavity, opening, recess, passageway or joint in a portion of the limbs or spinal column) (e.g., abstract, [0003], [0005]-[0010], [0052]-[0053], [0061], [0062], [0069] and claims 1 and 15 of prior art) (instant claim 21, 34-36 and 42-43).
It would have been obvious to modify the teachings of Wang with various surgical sites, additional therapeutic agent, and aqueous solution of starch crosslinker of Tijsma in order to enhance intended therapeutic effects on target sites or surgical areas, as taught by Tijsma.
However, Wang in view of Tijsma does not expressly teach calcium toughening treatment of instant claims 37-41. The deficiencies are cured by Bianco-Peled.
Bianco-Peled teaches tissue adhesive composition and method of applying the same; the composition comprises a) pre-gel that comprises at least one phenol-based compound, and at least one water miscible polymer such as sodium alginate; a cross-linking agent capable of interacting with said at least one water miscible polymer wherein the cross-linking agent is calcium carbonate or calcium chloride, b) solid support, and c) at least one trigger compound such as acetic acid of triggering release of multivalent ions from the crosslinking agent into the pre-gel wherein upon blending the pre-gel with the trigger compound the pre-gel hardens and forms an adhesive material (claims 47, 48 and 59, [0033], [0062] and [0086] of prior art), and when the composition is applied, it allows on-site curing of the adhesive and usage of the adhesive material as an affective sealant especially for medical use ([0010]); and the formed adhesive composition has higher adhesive strength and the composition further comprises therapeutic materials selected from one or more of a group comprising drugs, growth factors, and hormones (claim 58 of prior art) (instant claims 37-41).
Further, it would have been prima facie obvious to one of the skilled in the art before the effective filing date of the claimed invention to modify crosslinker of Wang with the combination of a calcium salt of calcium chloride or calcium carbonate and a triggering compound acetic acid as taught by Bianco-Peled, in order to achieve the instantly claimed invention.
One of the skilled in the art would have been motivated to do so because both references Wang and Bianco-Peled relate to provide tissue adhesives using natural polysaccharides; Wang teaches mixture of natural polymers and acetic acid, and Bianco-Peled teaches a combination of trigger compound acetic acid and crosslinking agents such as calcium salt where the crosslinking agent is capable of interacting with the polymer and to pre-gel, and the trigger compound is capable of triggering release of multivalent ions from the crosslinking agent into the pre-gel, and then allowing the pre-gel to harden and adhere onto tissue surface, and therefore, there is motivation to further treat the polysaccharide gel of Wang with cross-linking agent/acetic acid of Bianco-Peled in order to form cross-linking while allowing the gel to be hardened (cured) and resultantly establishing effective adhesive and sealing properties, as taught by Bianco-Peled.
This rejection is based on the well-established proposition of patent law that no invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients, In re Sussman, 1943 C.D. 518. From MPEP 2143 A: “…all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).”
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims 20-43 would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 20-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of patent no. 10,835,635.
Although the claims at issue are not identical (instant method vs. tissue adhesive of patent ‘635), they are not patentably distinct from each other because both claim sets require mixture of chitosan and, sodium alginate, its identical or inside ratio, target site, therapeutic agent, gel formation, acetic acid-containing solution and toughening calcium salt containing aqueous solution. The difference between them is that the claimed invention is directed to a tissue adhesive and the patent ‘635 is directed to a method of forming a tissue adhesive. However, the patent ‘635 requires the same tissue adhesive.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘635 subject matter.
Claims 20-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of patent no. 11,571,492.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require mixture of chitosan and sodium alginate, its identical or inside ratio, starch, surgical target site, additional therapeutic agent, gel formation, acetic acid-containing solution and toughening calcium salt containing aqueous solution. The difference between them is that the patent ‘492 method requires mixing and spraying steps in addition to positioning step, and however, the claimed method recites “comprising” which does not exclude introduction of additional steps.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘492 subject matter.
Claims 20-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of patent no. 12,102,729B2.
Although the claims at issue are not identical (instant method vs. tissue adhesive of patent ‘729), they are not patentably distinct from each other. Both claim sets require the same tissue adhesive elements comprising a mixture of natural polymers which is a mixture of alginate and chitosan in a ratio of between 10:90 and 90:10 or 75:25 and 25:75, acetic acid as the activating agent, starch, additional therapeutic agents, and the tissue adhesive is applied to the tissue site including tonsillectomy surgery, surgical site created during tonsillectomy surgery, surgical site, burn site, skin donor site, skin graft site and a joinder. The difference between them is patent ‘729 requires specific amounts of pullulan aqueous solution and acetic solution. However, instant method further recites “comprising” which does not exclude introduction of such starch amounts. Other difference between them is that the claimed invention is directed to a tissue adhesive and the patent ‘729 is directed to a method of forming a tissue adhesive. However, the patent ‘729 requires the same tissue adhesive as in the claimed invention.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘729 subject matter.
Conclusion
All the examined claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613
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