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 .
Claim Objections
Claim 5 is objected to because of the following informalities: the claim provides for two different Markush groups; however, there does not appear to be any reason for these groups to be separate. Please provide items in one single Markush group or separate the groups into different claims. Appropriate correction is required.
Claims 13, 15, 17, 19 and 20 are objected to because of the following informalities: there is no reason these claims need to be directed to tables in the specification. See MPEP 2173.05(s). Appropriate correction is required.
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, 2, 8-10, 12, 13, 15, 16, 28 and 29 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. The claims are drawn to a composition defined b how it is made. That is to say, the claims are drawn to a composition comprising exosomes, wherein the exosomes are not described, but the cells generating the exosomes are. The cited claims provide for all cells that have increased GLUT4 activity, wherein there is no suggestion that the exosomes include GLUT4, only that the cells from which the exosomes are derived have increased GLUT4 activity.
Based upon the instant specification, the only applied examples provide for certain muscle cells, wherein these cells produce a very specific set of biomolecules. That is to say, if GLUT4 was overexpressed in a non-muscle cell or a non-animal cell, there is nothing to suggest that the cited biomolecules would be present. For example, GLUT4 can be overexpressed in the most widely used cell for producing biomolecules -yeast. See Kasahara, et al (Biochimica et Biophysica Acta, 1324, 111-119, 1997), page 111, “Abstract” section. However, since Kasahara was published in 1997, it is clear that the Applicant should not be entitled to any exosomes produced by these yeast cells. As such, since it is clear that the Applicant has provided for a very specific set of biomolecules, the Applicant should only be entitled to the elements that they invented, and had possession of.
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 2 and 25 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 2 provides for an optional limitation drawn to a sequence; however, no sequence is claimed. If a limitation is drawn to a sequence, but no sequence is provided, the limitation must be indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 25 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. This limitation does not limit the parent claim because it is unclear if this intended use is meant to somehow limit the structure of the claimed composition. Since it appears that the claim is merely providing a subject pool for a method, the limitation does not further limit the parent claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 5, 7-10, 12, 15-18, 20, and 22-25 rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) exosomes that contain naturally occurring biomolecules. This judicial exception is not integrated into a practical application because the claims provide for the exosome that contains naturally occurring biomolecules and nothing more.
The claims are drawn to a composition comprising exosomes from cells that overexpress GLUT4. When considering the actual contents of these exosomes, they are defined as possessing GLUT4 (claim 12), which is a naturally occurring biomolecule, and other naturally occurring biomolecules listed from tables 1-3; in fact, table 2 is explicitly listed as wild-type cells (unless this is a typographical error) and is explicitly listed in claims 15 and 17. Furthermore, based upon the tables, it appears as though the engineered cells that over express GLUT4 also provide for naturally occurring biomolecules, wherein the only difference between the biomolecule profile of the wild-type and engineered cells is an increase of biomolecules that already were being secreted by the wild-type cells. This change in concentration does not change the fact that not only are these biomolecules naturally occurring, they are routinely found within the same naturally occurring exosome produced by the wild-type.
For the analysis of the claims under 35 USC 101, the Applicant is directed to MPEP 2106, particularly the flow chart provided in section III. The first question of the flow chart asks if the claims are drawn to a statutory category. Since the claims are a composition, they are one of the statutory categories, and the answer is “yes.” The next question asks of the claims are drawn to a product of nature. Even though the cells have been engineered to overexpress GLUT4, it is clear from the specification that all of the claimed biomolecules naturally exist in an exosome naturally secreted from certain muscle cells. Since it is clear from the instant specification that the claimed exosomes contain only natural compounds wherein the only difference between the claimed exosome and a naturally occurring exosome is the concentration of biomolecules within the exosome, the composition as a whole must be considered a product of nature. The final question asks if there is anything claimed that amounts to significantly more than the judicial exception. Since the claims only recite the product of nature, the answer is “no,” and the claims are not patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 102
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 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, 8, 10, 12, 13, 15-18, 20, 22-25, 28 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hong, et al (PGPub 2018/0028600 [IDS Reference]). Hong teaches exosomes that posses GLUT4 in the membrane, wherein the exosome was produced by a cell that was engineered to overexpress GLUT4. See paragraph [0022].
With respect to claim 1, Hong teaches the claimed exosome.
With respect to claim 2, Hong teaches recombinant expression. See paragraph [0022].
With respect to claim 8, Hong teaches seeding the cells on plates. See paragraph [0072]. This implies two-dimensional culture.
With respect to claims 10 and 12, Hong teaches GLUT4.
With respect to claims 13, 15-18, and 20, although Hong does not explicitly describe the claimed biomolecules, Hong generates exosomes in a manner that appears to be identical to that claimed. As such, barring evidence to the contrary, the exosomes of Hong must inherently include the claimed molecules.
With respect to claims 22 and 23, as discussed above, Hong teaches GLUT4 overexpression and 2D cultures.
With respect to claim 24, Hong teaches pharmaceutical compositions. See paragraph [0047]. These necessarily read on the claimed “carrier.”
With respect to claims 25, 28 and 29, Hong teaches treating diabetes and related pathologies. See paragraph [0013].
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.
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.
Claim(s) 5, 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hong, et al (PGPub 2018/0028600 [IDS Reference]) and Beckerman, et al (Science Advances, 7, eabg3947, 2021). See the discussion of Hong above. Hong only teaches the overexpression of GLUT4 in HEK cells, not in other cell types.
Beckerman provides for the overexpression of GLUT4 in myotubes, as a therapeutic avenue for the treatment of diabetes. See page 1, “Abstract” section. Based upon this, it would be clear to the ordinary artisan that these two references are linked by GLUT4 overexpressed cells for the treatment of diabetes. The only main difference is that Hong provides for the administration of exosomes, whereas Beckerman implants whole cells, which would be expected to inherently produce exosomes, in situ.
The ordinary artisan would be motivated to apply Beckerman’s engineered myotubes, to Hong’s GLUT4 methodology, because Beckerman shows a clear improvement in glucose tolerance in test subjects. See page 1, “Abstract” section. Additionally, Beckerman notes that while the results were promising, other methods of providing GLUT4 to cells could be investigated. See page 9, left column, 1st paragraph. This would motivate the ordinary artisan to apply Beckerman’s use of myotubes to other methods of treating diabetes with GLUT4 overexpression.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
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