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 1-19, of record 5/23/2023, are pending and subject to prosecution.
Priority
The instant application is a CIP of application 16/069774 (filed 7/12/2018), which is a national stage entry of PCT/IL2017/050058 (filed 1/17/2017), which claims benefit of provisional application 62/279843 (filed 1/18/2016), and which claims benefit of provisional applications 62/279844 (filed 1/18/2016), 62/279845 (filed 1/18/2016), 62/376428 (filed 8/18/2016), and 62/434453 (filed 12/15/2016). The instant application also claims benefit to provisional applications 63/346926 (filed 5/30/2022) and 63/433491 (filed 12/19/2022). Pending claims 1-19 are directed to methods performed in microgravity conditions. Because the applications filed prior to 5/30/2022 lack support for culture in microgravity conditions, the earliest priority date to which the claims of the pending application is entitled is 5/30/2022.
Drawings
The drawings are objected to because a petition for the acceptance of color photographs and color drawings has not been granted. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The use of the terms Opti-MEM, Sf-900, MegaCell, Cytodex, Cytopore, McIlwain, AlexaFluor, Tween, GraphPad, Prism, Quinn’s Advantage, MSCgo, and NutriStem, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 5-11 and 14 are objected to because of the following informalities:
In line 7 of claim 5, “selected from” should be deleted.
In line 2 of claim 6, the words “cell line” should be inserted after “finite”, and the article “a” should be inserted in front of “continuous”. The words “glands” and “nerves” should be replaced with “gland” and “nerve”, respectively.
In lines 2-3 of claim 7, the words “cell line” should be inserted after “finite”, and the article “a” should be inserted in front of “continuous”.
In claim 8, “NOM” should be written out as “nasal olfactory mucosa”.
In line 1 of claim 9, the words “any one of” should be deleted.
In line 3 of claim 10, “L-15 Medium (Leibovitz)” should be written a “Leibovitz’s L-15 medium”. In line 6, “GMEM” should be deleted as a duplicate limitation. In line 7, “medium” should be inserted after “Claycomb”.
Claim 11 ends in a semicolon. Each claim must start with a capital letter and end with a period. See MPEP 608.01(m).
In claim 14, “nerve cells” should be replaced with “nerve cell’, “muscle cells” should be replaced with “muscle cell”, “oocytes or sperm cells” should be replaced with “oocyte or sperm cell”, “embryos” should be replaced with “embryo”, “myotubes” should be replaced with “myotube”, and “oocytes” should be replaced with “oocyte”.
Appropriate correction is required.
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 5-8, 10, 15-16, and 19 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 5 recites the limitations "the mammal cell culture” and “the mammal tissue culture” in lines 4 and 6. There is insufficient antecedent basis for these limitations in the claim. Dependent claims 6-8 are included in the rejection.
Claim 10 contains the trademarks/trade names Opti-MEM, Sf-900, and MegaCell. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe culture media and, accordingly, the identification/description is indefinite.
Additionally, it is unclear what is required by the limitations “HI medium”, “IPL-41 Insect Medium Sf-900”, and “TC-10 IPL-10 medium”, as these limitations are not defined by the instant specification or found as specific compositions in internet searches.
Claim 15 recites the limitations "the loss” in line 1. There is insufficient antecedent basis for this limitation in the claim. Dependent claim 16 is included in the rejection.
The limitation “long exposure” in claim 19 is a relative term which renders the claim indefinite. The adjective “long” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how long of a duration constitutes “long exposure”, therefore, one would be unable to determine infringement upon the claimed invention.
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.
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 1-11 and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ulbrich et al. (BioMed Research International, 2014) in view of Tolba et al. (Journal of Materials Chemistry B, 2016), of record in IDS filed 10/25/2023.
Regarding claims 1-11 and 13-19: Ulbrich et al. review the effects of microgravity on bone cells and MSCs (See Abstract). Loss of bone mass in subjects exposed to microgravity, up to 1% bone mass lost per month (which reads on “long exposure”), is well established and associated with a loss of calcium from the bone (See page 4, col. 1, ¶1-2). Osteoblasts derive from MSCs, but microgravity impairs the differentiation process, possibly through reduced proliferation and activity, reduced differentiation, and decreased responsiveness to bone-related factors in the microenvironment (page 4, col. 2, ¶1). Ulbrich et al. do not teach or suggest the use of amorphous calcium carbonate in microgravity bone cell or MSC culture or in vivo.
Tolba et al. teach the culture of MSCs and osteoblast-like SaOS-2 cells (which read on “biological culture”, “eukaryote… cells”, “animal… cells”, “cell culture… stem cells… of human”, “continuous cell line”) in media comprising amorphous calcium carbonate (See Abstract). The cells were cultured in McCoy’s (which reads on “McCoy’s 5A Modified Medium”) or α-MEM (which reads on “MEM”) medium (which read on “an artificial medium selected from balanced salt solutions, basal medium and complex medium”) (See page 378, col. 1, ¶3 and col. 2, ¶1-4). The amorphous calcium carbonate was stabilized with polyphosphate and formed 100-200 nm (which reads on “about 10 nm to about 500 nm”) nanoparticles (See page 380, col. 1, ¶1 and col. 2, ¶1). The amorphous calcium carbonate preparations were found to promote osteogenic activity (which reads on “preventing the loss in the mass of a musculoskeletal system”, “osteocytes formation”, “preventing the loss in the mass of a bone”, and “treating damages”) in both MSCs and SaOS-2 cells in the presence of a mineralization-activating cocktail (See fig. 8). Tolba et al. also demonstrate biocompatibility of microspheres comprising amorphous calcium carbonate implanted into mice (See page 383, col. 2, full ¶1).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the instant invention to modify the teachings of Ulbrich et al. to comprise the addition of amorphous calcium carbonate, such as is taught by Tolba et al., for the growth and differentiation of MSCs and osteoblasts in microgravity conditions in vitro and in vivo. One would be motivated to make this modification because Tolba et al. teach that amorphous calcium carbonate promotes in osteoblast-like bone cells and MSCs osteogenesis and osteogenic differentiation (See fig. 8), processes which are taught by Ulbrich et al. as being impaired in microgravity (See page 4, col. 2, ¶1). There would be a reasonable expectation of success in doing so because Tolba et al. demonstrate that amorphous calcium carbonate can be added to bone cell and MSC media to good effect and that it is biocompatible in animal studies (See page 383, col. 2, full ¶1 and fig. 8).
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ulbrich et al. (BioMed Research International, 2014) in view of Tolba et al. (Journal of Materials Chemistry B, 2016), of record in IDS filed 10/25/2023, further in view of Sagi et al. (US 20150056306 A1).
Regarding claim 12: Following the discussion of claims 1-11 and 13-19, Ulbrich et al., modified by Tolba et al., render obvious the use of amorphous calcium carbonate for supporting and enhancing bone cell and/or MSC growth and differentiation in microgravity conditions but do not teach the amorphous calcium carbonate as stabilized by phosphoserine, citric acid, or chitin.
Sagi et al. teach the use of amorphous calcium carbonate for preventing bone density loss (See ¶0069-0070 and 0072). The amorphous calcium carbonate can be stabilized with components such as phosphoserine, citric acid, and chitin (See ¶0016, 0022, and 0062-0064).
It would have been obvious to one having ordinary skill in the at prior to the effective filing date of the claimed invention to modify the method of Ulbrich et al., modified by Tolba et al., to substitute phosphoserine, citric acid, or chitin as the stabilizer for amorphous calcium carbonate in place of polyphosphate. Substitution of a known element for another known element is considered to be prima facie obvious, absent a showing that the substitution yields more than predictable results. See MPEP 2143(I)(B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER S SPENCE, whose telephone number is 571-272-8590. The examiner can normally be reached M-F 8:30-5:30.
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/J.S.S./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633