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 .
Claims 1-9, 11, 12, 14, 20-23, 25-26 and newly presented claims 27-30 are still at issue and are present for examination.
Claims 10, 15-19, 24 remain withdrawn as drawn to non-elected invention.
Applicants' arguments filed on 5/5/26 have been fully considered and are deemed to be persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
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 7 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 phrase “non-water-miscible liquid” in claim 7 is confusing. It is unclear of applicant means “water-immiscible liquid” or he/she is referring to something else. Also, the metes and bounds of said phrase are unknown as said phrase has not been defined in the disclosure.
Claim 12 remains 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. In claim 12, the phrase “crosslinking enzymes” is unclear. In page [0032], some embodiments of said phrase are mentioned without clearly specifying the metes and bounds of said phase. Appropriate clarification is required.
Claims 1-9, 11-12, and 14 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. In claim 1 (and its dependent claims 2-9, 11-12, 14) it is unclear what “gas mixture” was utilized. Claims 2-9, 11-12, 14 are merely rejected for depending from claim 1.
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.
Claims 1-9, 11-14, 20-23, 25-30 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. Claim 1 (and its dependent claims 2-9, 11-14) and claim 20 (and its dependent claims 21-23, 25-30) are directed to a method of use of a genus of “gas mixture(s)”, and hollow spheres comprising a genus of “a least one gas”, respectively, wherein said gas genera are inadequately described in the disclosure.
The disclosure does not explain what types of gas or mixtures thereof may be utilized in the method of claim 1 (and its dependent claims 2-9, 11-14). No examples of such mixtures can be found in the disclosure either. The prior art is unpredictable as to which gases or mixtures thereof are likely to be used in the method of claim 1 such that they result in instantly claimed hollow spheres with “multiaxially and deformable walls”.
Given the fact that the gas mixture is required to create bubbles that need to penetrate successfully and in intact form to reach the crosslinking layer, where they will be singularized, some more information as to which types of gas or mixtures thereof are likely to produce bubbles that retain their integrity while passing through the separation layer and retain their singularity after being treated with crosslinking layer, deems necessary that is currently lacking in the disclosure.
All applicant provides is a single species (namely air), which is totally inadequate to fully describe the genus of gas mixtures utilized.
With respect to claims 20 (and its dependent claims 21-23, 25-30), which recites the genus of “at least one gas”, once again the specification fails to disclose any hollow spheres filled with any gas beyond “air” (i.e. a single species) and given the fact that said genus of hollow spheres can be formed by any ratios of collagen to derivatives thereof in a suspension or solution, and must possess walls that are “multiaxially and elastically deformable”, some more information as to which types of gas mixtures (made of two or more gases) are likely to produce hollow spheres having said gas mixture filled cavities, with collagen/collagen derivative membranes that are “multiaxially and elastically deformable”, deems necessary that is lacking in the disclosure.
All applicant provides is a single species and said description is totally inadequate to fully describe the genus of “at least one gas mixtures” recited in claim 20 and its dependent claims 21-23 and 25-30.
Therefore, based on the information provided one of skill in the art cannot reasonably conclude that applicant had full possession of the invention, before the effective filing of this application.
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.
Claim(s) 20-23, 25-30 remain rejected under 35 U.S.C. 103 as being unpatentable over Rhee (cited previously) according to previous office action.
In traversal of this rejection, applicant argues the following:
(1) that instant claim 20, is directed to hollow spheres prepared according to claim 1, said hollow spheres comprising collagen and at least one derivative thereof, wherein said spheres have “a multiaxially and elastically deformable wall”. Said hollow spheres are provided as in vitro models that exhibit an improved, realistic replication of and mechanical simulation of human cells and pulmonary alveoli, possessing high degree of similarity to human pulmonary alveoli along with tailored mechanical and physical properties.
Rhee cited previously, is directed to pharmaceutically-acceptable non-immunogenic compositions formed by covalent binding of atelopeptide collagen to pharmaceutically pure, hydrophilic polymers via specific chemical bonds in order to obtain conjugates. According to Rhee’s method, the synthetic hydrophilic polymer is activated and then reacted with collagen. Alternatively, the hydroxyl or amino groups of collagen may be activated and then reacted with the polymer to form conjugates.
Therefore, in view of applicant, a person of ordinary skill would have found no discernable disclosure of hollow spheres that includes “a multiaxially and elastically deformable wall” composed of collagen and at least one collagen derivative.
(2) example 7(b) of Rhee, discloses that a composition can be provided that is suitable for repairing load bearing bone defects (e.g. fractures, pseudoarthrosis etc.), and the insoluble component can be fibrillar cross linked collagen, gelatin beads, mineral beads or glass beads. However, Rhee fails to express or imply any teaching of applicant’s hollow spheres with “multiaxially and elastically deformable walls”.
(3) regarding the examiner’s comment that the crosslinked-collagen gelatin beads are inherently air filled, this interpretation fails to disclose or suggest the structure recited in claim 20. The examiner has failed to show that gelatin beads of Rhee include “multiaxially and elastically deformable walls”.
Therefore, applicant concludes that instant rejection should be withdrawn.
These arguments were fully considered but were found unpersuasive. With regards to applicant’s first argument above, it should be noted that firstly, instant claim 20 and its dependent claims are being assessed by their own merits and their patentability is not dominated by the method by which they are prepared. Secondly the intended use of said products are not recited in base claim 20. Thirdly, Applicant is reminded that in [0051] of the disclosure mentions that collagen derivatives may be prepared by chemical synthesis and in [0055], recites that crosslinking of instant hollow fiber membranes may be done by chemical crosslinking. Obviously, such chemical crosslinking and collagen derivative suspensions/solutions result in conjugated collagen/gelatin, which end up in the hollow spheres membranes of Rhee. Therefore, there is no reason to doubt that the method of Rhee fails to produce hollow beads with walls having the same properties as those of instantly claimed hollow spheres because as mentioned previously, instantly claimed hollow spheres are also disclosed to have been made out of fibrillar collagen (optionally derivatized) and gelatin.
With respect to applicant’s second argument, he/she is reminded that instant hollow spheres walls have been merely characterized by function. More specifically, the membrane elasticity (in terms of measurable units such as J/m2) and axes of orientation of different layers which form sphere(s) walls, are not recited in claim 20 (and its dependent claims 21-23, 25-30). Further, for argument’s sake, even if one restricts the scope of claims 20 to those prepared by the method of claim 1, said method claim does not even specify the relative ratios of collagen/collagen derivatives etc. in the starting solution of suspension utilized. Finally, regarding Rhee’s beads (spheres) potential utility mentioned above by applicant, he/she is fully is aware that natural bones do have some level of elasticity by inherency, and for the hollow beads of Rhee to repair bone fracture mentioned above by applicant, they must inherently have elasticity and multiaxiality, in order to be operational and effective.
Regarding applicant ‘s third argument, he/she once again relies on the “phrase “a multiaxially and elastically deformable wall ….” to overcome the art but said functional language is inadequate to overcome the art of record for the same reasons explained above.
Therefore, this rejection is maintained for the reasons explained above, in addition to those mentioned previously.
No claim is 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 MARYAM MONSHIPOURI whose telephone number is (571)272-0932. The examiner can normally be reached full-flex.
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, Melenie L Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARYAM MONSHIPOURI/Primary Examiner, Art Unit 1651
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