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 08/01/2023 is acknowledged.
Election/Restriction
Applicant's election with traverse of Group I, claims 17-31 in the Reply of 08/01/2023 is acknowledged. By way of applicant’s election, claim 32 has been withdrawn from further consideration. Further, applicant elected species “o-nitrobenzyl photo-trigger group” represented by formula (I) or (II) for the functional component. Thus, active ester group (III) and (IV), isocyanate group (V), isothiocyanate group (VI), epoxide group (VII), cyclic carbonate group (VIII), cyclic thiocarbonate group (IX), active carbonyl group (X) or active double bond group (XI) of claim 18 have been withdrawn.
Consequently, claims 17-31 are examined on the merits to which the following grounds of rejections are applicable.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that Groups I and II are at best different embodiments of a single inventive concept and two groups do not constitute distinct invention and since all the claims share the same common technical features, different search is not required by PTO to examine the allegedly separate invention; species do not constitute distinct inventions such as to require that their subject matter be prosecuted in separate application.
The Examiner responds that shared technical features were known before the effective filing date of the invention in the prior art (US2020/0262939, IDS of 08/01/2023) as noted in the restriction requirement action, and thus, they cannot be considered contribution over the prior art that would otherwise unify the Groups. Therefore, Group I directed to a tissue adhesive and Group II directed to a method of fabricating the medical tissue lack unity under PCT rule 13; and further, the instant application is a national stage entry of a PCT, which follows Unity of Invention rules. See MPEP § 823. There is no requirement for a showing of undue burden in searching the groups together under the Unity of Invention rules. See MPEP §1893.03(d); and finally, species for each tissue-adhering functional groups have mutually exclusive characteristics in chemical structure and properties. For those reasons, the restriction requirement is deemed proper and is therefore made FINAL.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/01/2023 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.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc. See MPEP 608.01(b)
In the instant case, the abstract consists of 180 words, which is not complying with the above guideline.
Appropriate correction and substitute abstract are requested.
Claim Objections
Claims 19-22, 24 and 31 are objected to a minor informality under 37 CFR 1.75.
Each of claims 19-22 recites “polyethylene glycol”; and claim 20 also recites abbreviation “PEG”. Therefore, it would be better to recite “polyethylene glycol (PEG)” in instant claim 19, and then recite “PEG” in each of claims 20-22.
Claim 24 recites “polycystaine”, which is a typo and should be corrected to “polycysteine”.
Claim 31 recites “1: (0.01-10): (0.1-30), but which would be better to recite either 1: 0.01-10: 0.1-30 for the claim self-consistency. Thus, please remove the parenthesis.
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 17-18 and 28 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.
Each of claims 17-18 and 28 recites “micro/nano particles”, but it is not clear whether it means 1) microparticles and nanoparticles, 2) microparticles or nanoparticles, or 3) microparticles and/or nanoparticles.
Appropriate correction is 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 CN 107987287B (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 08/01/2023:
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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) and thus, Formula A-1 or A-II reads on the claimed functional component (instant claims 17, 18, 27 and 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 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 ([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 and peroxide read on the claimed dispersant (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.
Conclusion
No claims are allowed.
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