DETAILED ACTION
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 included in prosecution are claims 19-29.
Response to Restriction Requirement
Applicant's election with traverse of Group I, claims 19-29 in the reply filed on 4/20/26 is acknowledged. The traversal is on the ground(s) that examining the different groups identified in the restriction requirement mailed on 2/18/26 together does not constitute a serious burden. This is not found persuasive because burden consists not only of specific searching of classes and subclasses, but also of searching multiple databases for foreign references and literature searches. Burden also resides in the examination of independent claim sets for clarity, enablement and double patenting issues. Further, a reference that would anticipate the invention of one group would not necessarily anticipate or even make obvious another group. Finally, the consideration for patentability is different in each case. Thus, it would be an undue burden to examine all of the above inventions in one application and the restriction for examination purposes as indicated above is deemed proper.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 30-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
1. Claims 19-29 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 19 recites “and contains the gelatin inside thereof, and the gelatin is distributed through the inside thereof”. The claim is indefinite insofar as it is not clear what the gelatin is “inside thereof”. For instance, is it distributed throughout the alginic acid or if the alginic acid coats the gelatin.
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 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.
1. Claim(s) 19-27 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quintens et al. (US 2014/0010918, Jan. 9, 2014) (hereinafter Quintens).
Quintens discloses dried powder solid particles containing a probiotic microorganism and a carrier phase wherein said probiotic microorganism is encapsulated (Abstract). In a preferred embodiment, the carrier phase comprises at least one substance chosen from alginate and gelatin (satisfies gelatin inside carrier of claim 19) (¶ [0016]). More preferably, the dried powder solid particles comprise an external coating which may comprise alginate, gelatin, or their mixture (satisfies claim 25) (¶ [0021]). The solidification step of the alginate solutions in the preparation methods of the beads was utilized using calcium lactate solution or CaCl2 solution (satisfies claim 22) (See Examples). Preferably, the produced spherical particles have a diameter in the range of 100 to 10000 μm (satisfies claim 24) (¶ [0054]). Examples which utilized gelatin utilized a 5 % solution (w/w) (satisfies claim 26) (See Examples).
The prior art is not anticipatory insofar as this combination must be selected from different lists/locations in the reference. It would have been obvious, however, to have made an gelatin, alginate solidified using a calcium ion containing solution, and wherein the gelatin is contained within the carrier phase of the particles and coated on the outside, as instantly claimed, since 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. See MPEP § 2143 (I)(A).
Regarding claims 20-21, and 27, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(I). The dried particles of Quintens comprises substantially the same components where it comprises gelatin, alginate solidified using a calcium ion containing solution, and wherein the gelatin is contained within the carrier phase of the particles and coated on the outside. Furthermore, the particles of Quintens have a particles size that overlaps with that of the instant claims and are dry. As such, one of ordinary skill in the art would reasonably conclude that the dried particles of Quintens would result in the same properties, having β (before pulverization)/ α (before pulverization) of 4.96 or more, α (after pulverization)/ α (before pulverization) of 0.08 or more, and a nitrogen content of 0.43%, as the microcarrier of the instant claims.
Regarding claim 23, as discussed above, the carrier phase may comprise a mixture of alginate and gelatin. As such, if they are mixed together it would be reasonable for one of ordinary skill in the art to conclude that they are at least partially bonded together.
Regarding claim 29, as discussed above, Quintens discloses dried powder solid particles. It would be reasonable for one of ordinary skill in the art to conclude that a dried powder contains negligible amounts of moisture. Consequently, Quintens’ disclosed dried powder solid particles satisfy the claimed limitation.
Accordingly, the teachings of Quintens render obvious claims 19-27 and 29.
2. Claim(s) 23 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quintens et al. (US 2014/0010918, Jan. 9, 2014) (hereinafter Quintens) in view of Giraudier et al. (Biomacromolecules, 2004, 5, 1662-1666) (hereinafter Giraudier).
It is believed that Quintens renders obvious claim 23 as discussed in the rejection supra.
However, assuming, purely arguendo, that claim 23 also refers to chemical bonding the rejection below is made.
The teachings of Quintens are discussed above.
Quintens differs from the instant claims insofar as not disclosing wherein the gelatin is bonded chemically to the alginic acid.
However, Giraudier explores the relative influence of physical and chemical bonds to overall gel properties in gelatin gels. They found that enzyme hydrolysis of covalent (meeting chemical bonds) gels is slower than that of physical gels (Abstract).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have formulated the gelatin of Quintens to be at least partially bonded to the alginic acid through chemical bonds motivated by the desire to slow down the enzymatic hydrolysis of the microsphere when they are administered to a patient.
Conclusion
Claims 19-29 are rejected.
Claims 30-37 are withdrawn.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A./Examiner, Art Unit 1612
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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