DETAILED ACTION
1. 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 election without traverse of Group I in the reply filed on 9/16/2025 is acknowledged. Applicants further election of the species implant, DMEM, microparticle between 1 micron and 5 mm in diameter, and polymeric matrix carrier is acknowledged.
Claims 12-16, 20-23, 26, 30 and 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/16/2025.
INFORMATION DISCLOSURE STATEMENT
2. Information Disclosure Statements filed 12/3/2023 is acknowledged.
Claim Rejections- 35 USC § 112
3. 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 5 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.
Claim 5 recites wax-like substance and absent a clear definition of what constitutes wax “like” substance the metes and bounds of the claim are unclear.
Claim Rejections- 35 USC § 102
4. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Singh et al. "Controlled release of glucose through modified chitosan membranes".
Singh et al. "Controlled release of glucose through modified
chitosan membranes" (hereinafter Singh et al. ) disclose a nutritional support material
for supplementing tissue survival comprising a slow-elution carrier controlling nutrient
release and a nutrient cocktail that comprises glucose and wherein the slow-elution
carrier specifically has a release half-life of between 30 minutes and 14 days (greater
than 0 minutes to at least 700 minutes(11.67 hours)) (title, abstract page 1, page 108,
page 110, Fig 2). Singh et al. disclose hydrogels are good candidates for the use in medical implants (introduction). The carrier is chitosan (polymeric material) (introduction).
5. Claims 31 and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. “Randomized controlled clinical trial of 2 types of hydroxyapatite-coated implants on moderate periodontitis patients”.
Kim et al. “Randomized controlled clinical trial of 2 types of hydroxyapatite-coated implants on moderate periodontitis patients” (hereinafter Kim et al.) disclose hydroxyapatite (e.g., nutritional support) coated implants. With regards to the limitations “a composition for increasing healing at the site of a tissue injury, disease or wound”, these limitations are regarded as intended use of the composition and are given little patentable weight. Tthe claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art
Claim Rejections- 35 USC § 103
6. 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.
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.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. "Controlled release of glucose through modified chitosan membranes"” in view of Freeland et al. (US 20230287334).
Singh et al. has been discussed supra and does not disclose media powder. Freeland et al. (US 20230287334) (hereinafter Freeland et al.) disclose complete media powder which offers all the necessary nutrients and chemicals for maintaining an environment for cell growth without and steps other than dissolution by the user (para 0033). It would have been prima facie obvious to one of ordinary kill in the art before the effective filing date of the instant invention to include media powder in the compositions of Singh et al. One would have been motivated to do so because it taught to provide the necessary nutrients for cell growth.
7. Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. "Controlled release of glucose through modified chitosan membranes"” in view of Ott et al. (US 20220233454).
Singh et al. has been discussed supra and does not disclose microparticles between 1 micron and 5 mm in diameter.
Ott et al. (US 20220233454) (hereinafter Ott et al.) disclose microparticles for localized delivery and sustained release of therapeutic cells and/or tissues at a site of implantation (para 0004).
Ott et al. disclose hydrogel microspheres or microparticles have an average (mean) maximum cross-section surface-to-surface dimension (i.e., in the case of a spherical or ellipsoidal microsphere, its diameter) of greater than 30 µm, and in some case greater than 300 µm. In one or more embodiments, the resulting hydrogel microspheres or microparticles have an average (mean) maximum surface-to-surface dimension of less than about 5 mm. Preferably, the resulting hydrogel microspheres or microparticles have an average (mean) maximum surface-to-surface dimension of less than about 2 mm, more preferably from about 30 µm to about 2 mm, even more preferably ranging from about 50 µm to about 1.5 mm, more preferably from about 150 µm to about 1.5 mm, even more preferably from about 300 µm to about 1.4 mm. In some cases, smaller microparticles ranging from about 30 µm to about 750 µm or 500 µm in size can be formed (para 0066). Ott et al. disclose the hydrogel microparticles allow the cells to be maintained in the localized region of implantation for a longer period of time compared to other carriers or unencapsulated cells, and provide a temporary, but sustainable, release of the cells and/or their signaling molecules, proteins, etc. to the region to improve the therapeutic effect of the implanted cells. It will be appreciated that cell loading will depend upon the size of the cells used and the size of each microparticle (para 0049).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to optimize the size of the microparticles. One would have been motivated to do in order to obtain the desired cell loading because cell loading depends on the size of the microcapsules.
8. Claims 1, 11 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. "Controlled release of glucose through modified chitosan membranes"” in view of Nuti et al. (US 20140206022).
Singh et al. has been discussed supra and does not disclose the nutrient cocktail comprises DMEM.
Nuti et al. (US 20140206022) (hereinafter Nuti et al.) disclose nutrient mediums that can support cell viability, cell metabolism, cell growth, cell differentiation or any combination thereof include those such as DMEM (para 0045). Nuti et al. also disclose the nutrient media further includes antibiotics. One of ordinary skill in the art would readily appreciate that the addition of antibiotics would suppress growth of undesirable microorganisms.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to further include DMEM in Singh et al. One would have been motivated to do so because it is a known nutrient medium that supports cell viability.
CORRESPONDENCE
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANAH AL-AWADI/Primary Examiner, Art Unit 1615