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 17-32 are currently pending and a preliminary amendment to the claims filed on 06/01/2026 is acknowledged. Claim 32 has been withdrawn, and thus, claims 17-31 are being examined.
New Grounds of Objection/Rejections --- as necessitated by amendment
Claim Objections
Claims 17-18 are objected to a minor informality under 37 CFR 1.75.
Claim 17 recites “consisting sorely of”, but the term “sorely” is redundant because the language of “consisting of” is limited to recited ingredients.
Claim 18 recites “comprising” in line 2, but which should be corrected to “comprises”. Appropriate correction is requested.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 17-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163.II.A.3.(b) states, “when filing an amendment an applicant should show support in the original disclosure for new or amended claims” and “[i]f the originally filed disclosure does not provide support for each claim limitation, or if an element which applicant describes as essential or critical is not claimed, a new or amended claim must be rejected under 35 U.S.C. 112, para. 1, as lacking adequate written description”. According to MPEP § 2163.I.B, “While there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure” and “The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117”.
Specifically, Claim 17 newly recites the negative limitation of “the tissue adhesive does not consist of water” in order to probably distinguish the claimed dispersing agent with water. However, that limitation does not appeared to be supported by the originally filed application. That is, the specification fails to expressly disclose “water” as one of tissue additive element, besides body fluid water. In this context, see MPEP 2173.05 (I): “Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) (“[the] specification, having described the whole, necessarily described the part remaining.”). See also Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff’d mem., 738 F.2d 453 (Fed. Cir. 1984). The mere absence of a positive recitation is not basis for an exclusion. Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. Note that a lack of literal basis in the specification for a negative limitation may not be sufficient to establish a prima facie case for lack of descriptive support. Ex parte Parks, 30 USPQ2d 1234, 1236 (Bd. Pat. App. & Inter. 1993). See MPEP § 2163 - § 2163.07(b) for a discussion of the written description requirement of 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph.
Accordingly, in the instant case, the recited negative limitation in claim 17 is neither alternative exclusion nor explicit original disclosure. Thus, claim 17 raises a new matter issue. The other remaining claims 18-31 are also rejected due to the rejection of base claim 17.
Claims 17-31 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 17 recites “the functional component comprises polymer chains, or microparticles or nanoparticles modified with tissue-adhering functional groups” in 5-7. However, it is not clear whether the functional component comprises either “1)a) any polymer chains, or b) any microparticles or nanoparticles modified with tissue-adhering functional groups”, or “2)a) polymer chains modified with tissue-adhering functional groups, or b) microparticles or nanoparticles of the polymer chains modified with tissue-adhering functional groups”. According to the specification (see instant publication at [0037], it appears that claim 17 intends to recite “2)a) or 2b)”. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057. First, in claim construction, one must not import limitations from the specification that are not part of the claim. Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349, 1354 (Fed. Cir. 2012).
Appropriate clarification is respectfully requested.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 17-31 are rejected under 35 U.S.C. 103 as being unpatentable over CN107987287B (IDS of 08/01/2023, hereinafter CN ‘287, citation is obtained from corresponding Google English Translation) in view of CN104507507A (IDS of 08/01/2023, citation is obtained from corresponding US2013/0344131A1, hereinafter US ‘131).
Applicant claims the below claim 17 filed on 06/01/2026:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “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 level of skill is that of a medical tissue adhesive research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from tissue adhesive medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
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) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
CN ‘287 discloses photoinduced nitroso crosslinking hydrogel material for preparing a hemostatic material, containing component A o-nitrobenzyl type photo-trigger modified macromolecular derivatives which is represented by the following formulae A-1 and A-II:
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wherein each R’, R1-R3 and R5 is hydrogen, R4 is modified alkyl group (elected species: see Formula A-1 or A-II) (e.g., claims 1, 5 and 10 of prior art) which reads on the claimed tissue-adhering functional group, and P1 is hydrophilic or water-soluble natural or synthetic polymer (claim 1 of prior art) including natural polysaccharide such as hyaluronic acid, CMC, MC, HEC, HPC, HPC, chitosan, synthetic polymer comprising two-arm or multi-arm PEG, polylysine, polyacrylate, etc. (claim 2 of prior art) which formula A-1 or A-II reads on the claimed functional component of polymer chains modified with tissue-adhering functional groups, (instant claims 17, 18, 27 & 29-30: functional component); the hydrogel material comprises component B selected from one or more than one of the following polymers: hydroxyl group-containing polymer derivatives, mercapto group-containing polymer derivatives, sulfonic acid group-containing polymer derivatives, carbonyl group-containing polymer derivatives, and double bond group-containing polymer derivatives (e.g., claim 6 of prior art) and the component B is represented by Formulae B1-BV (e.g., claim 11 of prior art) and e.g., the amino, hydroxyl or carboxyl -containing polymer derivatives include a water-soluble or hydrophilic polymer containing n amino group, hydroxyl group or carboxyl groups and e.g., polylysine, hyaluronic acid, alginic acid, heparin, collagen, CMC, chitosan or its derivatives, polygelatin, PEG, multi-arm amino PEG etc. (bridging paragraph pages 37-38 of translation) which reads on the claimed assistant crosslinker (instant claims 17, 23 and 24: assistant crosslinker). Components A and B are crosslinked to form hydrogel (see e.g., the Examples and claim 5 of prior art).
However, CN ‘287 does not expressly teach polyhydric dispersant of instant claims 17, 19-22 and 25; and microparticles of functional component of instant claims 17 and 28. The deficiencies are cured by US ‘131.
US ‘131 discloses hemostatic materials such as biocompatible crosslinked material such as calcium alginate polymer chain ([0054]-[0055] and [0065]), collagen, gelatin, chitosan, CMC, hyaluronan ([0058]), and the hemostatic materials can be in the form of particles of clay materials, or other hemostatic materials such as other silica-based materials, bioactive glasses, biological hemostats, molecular sieve materials, diatomaceous earth, calcium alginate, chitosan, thrombin, combinations of the foregoing, and the like ([0036], [0082], [0090] and [0130]), and for example, solid suspension containing hemostatic material was then filtered using a 0.2 micron filter which means the particles in the suspension is less than 0.2 micron (instant claims 17 and 28: micro/nanoparticles); as a binder capable of forming crosslinks, polyol such as glycerol, glycol, chitosan and CMC, PVP, sorbitol, xylitol, maltitol, polymeric polyol, etc. can be used ([0074], [0076] and [0077]) which has a formula CnH2n-m+2(OH)m wherein n is 2 or greater and m is less than or equal to n, and the polyol such as glycerol is water-soluble liquid that is compatible with biological tissue ([0077]); and the crosslinks can be formed by chemical reactions that are initiated by heat, and e.g., peroxide can be used to prepare polyethylene crosslinker ([0069]) in which the polyol reads on the claimed dispersant, and the peroxide reads on the claimed assistant crosslinker (instant claims 17, 19-22 and 25: dispersant).
It would have been obvious to modify the teachings of CN ‘287 with microparticles of polymer and polyol or peroxide dispersant of US ‘131 in order to enhance the properties of hemostatic composition and in particular polyol and peroxide plays a role in crosslinking, and thus, can prevent a hemostatic material from being swept away upon contact with blood, allowing the hemostatic material to be in contact with the wound.
However, CN ‘287 in view of US ‘131 do not expressly teach the ratio of instant claim 31. However, CN ‘287 discloses the mol ratio of the carboxyl, hydroxyl or amino in the water-soluble polymer to the micromolecule o-nitrobenzyl derivatives is preferably 1: 0.1-2 (page 36 of the translation) and Example 1 (e.g., Synthesis of component A-1 or A-2), and US ‘131 discloses polyol/peroxide dispersant and the ordinary artisan would optimize the amounts of the applied art with the claimed ratio, unless the ratio shows criticality (instant claim 31). In this respect, see MPEP 2144.05 (II)(A): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined 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 at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that CN ‘287 discloses the hydrogel can be directly applied to the surface of biological tissues such as wounds, and form a gel in situ after application, and US ‘131 discloses a hemostatic material containing polyol, particles of kaolin, etc. and however, polyol is used as a binder, which is not directly applied to the wound surface to achieve hemostasis, nor is there a situation where the hemostatic material forms a gel in situ at the wound site
The examiner responds that the hemostatic agent and/or binder such as calcium alginate can itself be configured to absorb blood ([0098] and [0105] of US ‘131), and the binder may itself be a hemostatic agent which may or may not be used in combination with other hemostatic agents ([0009] of US ‘131); the concentration of the polyol is such that at least some of the alcohol component thereof seeps to the wound-contacting surface of the substrate 510 ([0128] of US ‘131); and Fig. 5B of US ‘131 illustrates that binder 550 and hemostatic materials contact wound-contacting site. From the teachings/suggestions of US ‘131, binder such as polyol can contact the wound area.
Applicant argues that US ‘131 discloses hemostatic effect is primarily achieved by relying on hemostatic materials such as clay, and CN ‘287 does not contain clay material as a hemostatic agent nor a substrate for the hemostatic agent to adhere to; and since the claimed medical tissue consists of functional components, assistant crosslinkers, and dispersing agents, when it comes into contact with the surface of biological tissues, the medical tissue adhesive of this application will not “float” on top of liquids such as blood or tissue fluid while enhancing adhesion, and will avoid the problems of uneven gel and insufficient strength caused by dilution of the functional components, and also ensure that the crosslinking and solidification of the gel only occur in the wound area, avoiding the formation of excessive non-adhesive areas in the final hydrogel, and consequently, the blood or tissue fluid on the surface of biological tissues is first displaced by the dispersing agent, and only then does the crosslinking process occur through the dissolution of the water-soluble dispersing agent and the blood or tissue fluid on the surface of biological tissues.
The Examiner responds that US ‘131 teaches/suggests the hemostatic materials can be in the form of particles of clay materials, or other hemostatic materials such as other silica-based materials, bioactive glasses, biological hemostats, molecular sieve materials, diatomaceous earth, calcium alginate, chitosan, thrombin, combinations of the foregoing, and the like ([0036]) and that is, various materials as noted above can be used as hemostatic materials, and the hemostatic materials in the substrate contact wound area ([0010]); US ‘131 and CN ‘287 both are in hemostatic field, and thus US ‘131 would be combinable with CN ‘287 to provide hemostatic device; the alleged unexpected properties would be implicit from the medical tissue adhesive of CN ‘287 because CN ‘287 teaches the claimed three components, and hemostatic mechanism is similar to the claimed adhesive; the instant embodiments to show alleged unexpected results are not commensurate with the scope of the claimed invention because the embodiments require specific functional components, assistant crosslinkers and dispersing agents as well as their amounts. Accordingly, it may not be said that any functional ingredients/assistant crosslinkers/dispersing agents would behave in a manner similar to those of tested embodiments; and further, although the claimed adhesive uses “consisting of” language, the claimed elements of functional component, assistant crosslinker and dispersing agent are still broad; and the claimed invention is directed to a product, a medical tissue adhesive, not a method of making or a method of using, and thus, the claimed adhesive does not require “dispersing the functional component and the assistant crosslinker using a dispersing agent that is water-free yet water, consequently, soluble blood or tissue fluid is first displaced by the dispersing agent, then crosslinking, etc.”
In light of the foregoing, applicant’s arguments are not persuasive.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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