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 .
Applicant’s response to restriction requirement filed 11/17/25 is acknowledged. Applicant elected Group III (claims 20-26) with traverse.
In view of applicant’s amendments made to claims, Group I invention is hereby rejoined with the elected invention.
In traversing restriction held between Groups II and Groups I and III, applicant argues that said restriction is improper because (1) one of skill in the art would not have understood that Group II is a separate invention than the others because the device claimed is configured for producing the hollow spheres of Group III and (2) the examiner has not explained as to why said device is a separate invention than others and has failed to show that searching Group II invention with others does impose an undue burden on the Examiner.
These arguments were fully considered and were found unpersuasive.
With respect to applicant’s first and second arguments above, firstly, it is unclear as to what the term “configured” mean. Secondly no drawings or diagrams regarding said device can be found in the disclosure either. Therefore, in contrast to applicant’s view, by reading instant claims 15-19, one of skill in the art would have no idea how specific the device utilized is. In fact, by reading instant claim 15, one will only understand that the device is made of a container, a gas supply device and a separation device. Considering the constituents of said device, one of skill in the art readily envisions many other methods of using such device such as a method to scavenge unwanted constituents from a gas feed or a method for aeration of a liquid etc., wherein said methods have nothing to do with instant method of Group I. Applicant is reminded that a device is only examined based on its structural features and not by what it happens to contain.
Considering said facts, applicant can fully appreciate that for searching said device of Group II, the examiner has to attempt a totally different search than what is needed for Groups I and III inventions and such effort does impose an undue burden of searching on the examiner.
In summary, due to reasons explained above, in addition to those provided previously, restriction between Groups II and rejoined Groups I and III, is maintained and is hereby made Final.
DETAILED ACTION
In view of the fact that the invention is directed to hollow spheres and a method preparation thereof, claims 10 and 24 are hereby withdrawn because they are not hollow. Claim 13 is also withdrawn because said method does not use collagen derivatives but uses modifications of said derivatives.
Claims 1-9, 11-12, 14, 20-23, 25, 26 only are under examination on the merits.
On 1/27/26, a telephonic interview was held between the examiner and Mr. R. W. Mueller (the attorney of applicant), wherein some of the merits of the elected claims were discussed. However, said communication did not result in any claim amendments to push the case closer to allowance.
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 1-9, 11-12, 14 and 20-23, 25-26 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 and 20-23, 25-26), the last two lines, it is unclear what treatments constitute “further treatments of the hollow spheres to be carried out afterwards”. Also, it is unclear as to how much time constitutes “afterwards”.
Claims 2-9, 11, 12, 14 and 20-23, 25-26 are rejected merely for depending from claim 1.
In addition, in claim 3, it is unclear at which step of claim 1, the additives are added.
In claim 6, it is unknown if the suspension is a mixture of water or other solvent(s) with collagen or derivate thereof.
In claim 7, it is unknown which specific “non-water-miscible liquid” applicant is referred to.
In claims 1-6, 8-9, 11-12, 14, it is unknown what “separation liquid” is. In [0030], some embodiments of said phrase are recited without explicitly defining said phrase in terms of composition.
Claim 9 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. In claim 9, the phrase “particularly advantageously ethanol” is confusing. It remains unclear if ethanol is the only solvent used for separation or any “alcoholic solution” can be used as a solvent.
Claims 4 and 26 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 4 the term “preferably “ is confusing because it is unknown if other water soluble polymers beyond carbohydrates or polysaccharides may be used to adjust density and viscosity. In addition, it is unclear at which step in base claim 1, said water soluble polymers beyond carbohydrates or polysaccharides are added. This problem also exists in claim 26, which recites “preferably” in line 2 thereof.
Claim 11 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. In claim 11, The metes and bounds of the phrase “post-crosslinking liquid” is indefinite. In page 7, applicant has mentioned some “particularly advantageous” enzymes such as transglutaminase, carbodiimides etc. as constituents of such liquid without explicitly defining what said phrase is referring to. But no explicit definition for said phrase can be found in the disclosure. Appropriate clarification is required.
Claim 12 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. In claim 12, the term “preferably” (which itself is confusing) is utilized together with two “and/or” terms. In view of said confusion, it is unclear what constitutes the “post-crosslinking liquid” recited at the end of the claim.
Claim 20 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. In claim 20, it is assumed that “at least one gas” is referring to air. This is because the invention is directed to “hollow spheres” and not specific gas-filled spheres. Appropriate clarification is required.
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, 25-26 are rejected under 35 U.S.C. 102(b)(2) as anticipated by Rhee et al., “Rhee” (US patent No. 5,328,955, 7/1994) or, in the alternative, under 35 U.S.C. 103 as obvious over Rhee.
Said patent in its abstract teaches pharmaceutically acceptable, non-immunogenic compositions are formed by covalently binding atelopeptide collagen to pharmaceutically pure, synthetic, hydrophilic polymers via specific types of chemical bonds to provide collagen/polymer conjugates. The atelopeptide collagen can be type I, type II or type III and may be fibrillar or non-fibrillar.
In Example 7, part (B), Rhee teaches about a formulation comprising fibrillar crosslinked collagen, gelatin beads (which are inherently air-filled hollow spheres, as no mention is made of their contents in said patent ). Said beads also inherently have a multiaxially and elastically deformable wall because they are made of fibrillar collagen/gelatin similar to the products prepared by instant method, anticipating claims 20-23 or in the least render them obvious.
Regarding claims 25-26, applicant is well aware that the prior art is fully established for preparing specific size collagen/gelation particles with any wall thickness and claims 25-26 were readily obvious and enabled to one or ordinary skill , before the effective filing of this application and hence, said claims hardly contribute to the patentability of this invention.
No claim is allowed.
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