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 .
Status of Claims
Claims 1-20 are pending.
Priority
Claims 1-20 are a 371 of PCT/CN 2021/109807 filed on July 30, 2021, which has priority to foreign application CHINA 2020 10747824.0 filed on July 30, 2020.
Information Disclosure Statement
The information disclosure statement(s) submitted on March 19, 2023, and on February 20, 2024, were filed before the mailing of the First Office Action on October 4, 2025. The Non-Patent Literature is in compliance with the provisions of 37 CFR 1.97 and are being considered by the examiner.
Claim Objections
Claims 1, 2, 5-7, 11-13, 16-17, and 19 are objected to because of the following informalities:
Claim 1 recites “comprises damage to lung in function and/or tissue”. Proper English is “comprises damage to a lung [[in]] function and/or tissue”.
Claim 2 recites “wherein the mesenchymal stem cells is useful”. Proper English is “wherein the mesenchymal stem cells are [[is]] useful”.
Claim 5 recites “or MERS-Cov”. It should read as “or MERS-Co[[v]]V”.
Claim 6 recites “derived from tissues from human being such as at least”. Proper English is “derived from a human being, wherein [[such as]] at least…”.
Claim 7 recites “wherein the mesenchymal stem cell is a”. Proper English is “wherein the mesenchymal stem cells are [[is]] a”.
Claim 11 recites “administering a mesenchymal stem cell”. Proper English is “administering a composition of mesenchymal stem cells to a subject”.
Claim 12 recites “from damage to lung in function and/or tissue”. Proper English is “from damage to a lung [[in]] function and/or tissue”.
Claim 13 recites “damage to lung in function and/or tissue”. Proper English is “damage to lung [[in]] function and/or lung tissue”.
Claim 16 recites “or MERS-Cov”. It should read as “or MERS-Co[[v]]V”.
Claim 17 recites “derived from tissues from human being such as”. Proper English is “derived from tissues from a human being including [[such as]]”.
Claim 19 recites “derived from tissues from human being such as at least”. Proper English is “derived from a human being, wherein [[such as]] at least…”.
Drawings
The drawings are objected to because:
Fig. 9 Part B is not legible.
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.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Applicant is advised that should claim 1 be found allowable, claim 2 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 2 states that the use of mesenchymal stem cells, as found in claim 1, is used to treat lung damage resulting from a respiratory infection. However, Claim 1 already recites the use of mesenchymal stem cells for treating lung damage, and the mesenchymal stem cell structural and functional characteristics do not change based just because the intent to treat something different. Thus, despite the difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 1 be found allowable, claim 3 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 3 recites “wherein the lung damage comprises lung fibrosis”. However, Claim 1 is already generically claiming “lung damage” without limitation to the underlying cause or type. Because of this, Claim 3 is merely specifying a specific type of lung damage. Thus, despite the difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 1 be found allowable, claim 4 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 4 recites the use of mesenchymal stem cells according to claim 3. However, However, Claim 1 already recites the use of mesenchymal stem cells for treating lung damage, and the mesenchymal stem cell structural and functional characteristics do not change based just because the intent to treat something different. Thus, despite the difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 1 be found allowable, claim 5 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 5 recites the use according to claim 4 as it relates to a respiratory infection resulting from pneumonia caused by SARS-CoV-2, SARS-CoV, or MERS-C0V. However, However, Claim 1 already recites the use of mesenchymal stem cells for treating lung damage, and the mesenchymal stem cell structural and functional characteristics do not change based just because the intent to treat something different. Thus, despite the difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 1 be found allowable, claim 7 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 7 recites “wherein the mesenchymal stem cell is a homogenous composition or a mixed cell cluster…”. However, Claim 1 already broadly encompasses the use of mesenchymal stem cells of any form in the preparation of a drug for repairing lung damage. A homogenous composition or mixed cell cluster are obvious subsets of the mesenchymal stem cells in Claim 1. Thus, despite the difference in language, the claims have substantially the same scope
Applicant is advised that should claim 11 be found allowable, claim 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 12 recites a method for repairing lung damage where the subject suffers from lung function or lung tissue. However, Claim 11 is already directed to lung damage, and the damage is always to the tissue. This is true for function as well, since function is the same as tissue damage. Thus, despite the difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 6 be found allowable, claim 19 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 6 and Claim 19 have the exact same limitations with Claim 6 being dependent to Claim 1. Claim 19 is dependent to Claim 5 which is dependent to Claim 3 which is dependent to Claim 1. Claims 6 and 19 have the same identical language.
Applicant is advised that should claim 8 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 20 recites “more than about 98% by mass” in reference to the amount of mesenchymal stem cell drug composition. However, Claim 8 states “the drug for repairing lung damage comprises more than 95% by mass of mesenchymal stem cells”. The language of claim 20 is already present in Claim 8. Thus, despite a difference in wording, Claims 8 and 20 have the same scope.
Applicant is advised that should claim 11 be found allowable, claim 18 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 18 recites “wherein the mesenchymal stem cell is a homogenous composition or a mixed cell cluster…”. However, Claim 11 already broadly encompasses the use of mesenchymal stem cells of any form in the preparation of a drug for repairing lung damage. A homogenous composition or mixed cell cluster are obvious subsets of the mesenchymal stem cells in Claim 11. Thus, despite the difference in language, the claims have substantially the same scope
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 1-10 and 19-20 are directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter:
Step 1: is the claim to a process, machine, manufacture, or composition of matter? No, Claims 1-10 and 19-20 do not recite a process, machine, manufacture, or composition of matter. Claims 1-10 and 19-20 merely recite the “use” of mesenchymal stem cells for treating damaged lung tissue or lung function, which is framed as a purpose of intended application rather than a process with defined steps or a composition.
Based on the above analysis, Claims 1-10 and 19-20 are not directed to a statutory category under 35 U.S.C. §101 and is therefore considered non-patentable subject matter.
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 1-20 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.
Claim 1 uses the generic term “lung damage” as it relates to the use of mesenchymal stem cells in the preparation of a drug for repairing “lung damage” where lung damage occurs in both damage to lung function and/or lung tissue. The same generic scope of “lung damage” is present in each of the dependent claims, i.e. 2-10 and 19-20.
Claim 2 uses the generic term “lung damage” as it relates to the use of mesenchymal stem cells in the preparation of a drug for repairing “lung damage” where lung damage occurs in both damage to lung function and/or lung tissue.
Claim 3 uses the generic term “lung damage” as it relates to the use of mesenchymal stem cells in the preparation of a drug for repairing “lung damage” where lung damage occurs in both damage to lung function and/or lung tissue.
Claim 8 uses the generic term “lung damage” as it relates to the use of mesenchymal stem cells in the preparation of a drug for repairing “lung damage” where lung damage occurs in both damage to lung function and/or lung tissue.
Claim 9 uses the generic term “lung damage” as it relates to the use of mesenchymal stem cells in the preparation of a drug for repairing “lung damage” where lung damage occurs in both damage to lung function and/or lung tissue.
Claim 10 uses the generic term “lung damage” as it relates to the use of mesenchymal stem cells in the preparation of a drug for repairing “lung damage” where lung damage occurs in both damage to lung function and/or lung tissue.
Claim 11 uses the generic term “lung damage” as it relates to the use of mesenchymal stem cells in the preparation of a drug for repairing “lung damage” where lung damage occurs in both damage to lung function and/or lung tissue. The same generic term is present in each of the dependent claims, i.e. Claims 12, 13, 14, 15, 16, 17, and 18.
Claim 12 uses the generic term “lung damage” as it relates to the use of mesenchymal stem cells in the preparation of a drug for repairing “lung damage” where lung damage occurs in both damage to lung function and/or lung tissue.
Claim 13 uses the generic term “lung damage” as it relates to the use of mesenchymal stem cells in the preparation of a drug for repairing “lung damage” where lung damage occurs in both damage to lung function and/or lung tissue.
Claim 14 uses the generic term “lung damage” as it relates to the use of mesenchymal stem cells in the preparation of a drug for repairing “lung damage” where lung damage occurs in both damage to lung function and/or lung tissue.
Claim 20 uses the generic term “lung damage” as it relates to the use of mesenchymal stem cells in the preparation of a drug for repairing “lung damage” where lung damage occurs in both damage to lung function and/or lung tissue.
The specification provides antecedent basis for the use of mesenchymal stem cells in preparation of a drug for treating lung damage [¶ 0001].
Applicant’s specification states the disclosure relates to the field of biomedicine in the use of mesenchymal stem cells in preparation for repairing/treating lung damage [¶ 0001]. The specification further states that lung damage includes damage caused by COVID-19 [¶ 0002]. It also states that patients with severe COVID-19 are susceptible to inflammatory factor storms due to release of various inflammatory cells that ultimately lead to increased lung microvascular permeability and lung edema which leads to lung damage [¶ 0002]. The specification further states that mesenchymal stem cells have excellent effect on the repair/treatment of lung damage in subjects with viral pneumonia, especially from viral pneumonia caused by SARS-CoV-2 [¶ 0010]. Fig. 9 shows the effects after treating/repairing of lung damage in patients diagnosed with severe COVID-19 [¶ 0020]. The specification further states that mesenchymal stem cells are particularly useful for lung damage resulting from respiratory infection related to viral pneumonia, bacterial pneumonia or fungal pneumonia [¶ 0022]. The only examples provided in Applicant’s specification were subjects that had been diagnosed with COVID-19 [See ¶ 0036 and Table 1]. However, “lung damage” can occur from multiple causes. For example, Beitler et al. discusses the multiple types of injuries that result from mechanical ventilation [Ventilator-induced lung injury, Clin Chest Med., 2017]. Beitler et al., discussing ventilator induced lung injury, cites several types of injury classifications such as atelectrauma caused by sheer force resulting from certain types of lung units, or barotrauma that is a result of high transpulmonary pressure [Table 1]. Beitler et al. goes on to list several other types of mechanical induced lung injuries related to ventilators [Table 1]. This is also demonstrated in Fig. 1 describing transpulmonary pressure. Here, the specification is only disclosing a method related to treating lung damage associated with COVID-19 and not the generic use of mesenchymal stem cells for any type of lung injury. Because of this, it would be difficult for a person of ordinary skill in the art to determine what injuries, given the types and etiologies of lung injuries, could be treated using the claimed method of administering a composition made up of mesenchymal stem cells.
Given the generic term “lung damage” as it relates to treating a lung injury with a composition that includes mesenchymal stem cells, and the absence of teachings of what other causes or types of lung damage that results from different etiologies with different pathological mechanisms, the Artisan would not understand Applicant to be in possession of the generic scope of drug preparation that included mesenchymal stem cells for treating a lung damage that included both lung function and lung tissue.
Claims 2, 1, 3, 4, 6-15, and 17-20 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.
Claim 2 uses the generic term “respiratory infection” as it relates to a drug preparation that includes mesenchymal stem cells used to treat lung damage resulting from a respiratory infection.
Claim 3 uses the generic term “respiratory infection” as it relates to a drug preparation that includes mesenchymal stem cells used to treat lung damage resulting from a respiratory infection.
Claim 13 uses the generic term “respiratory infection” as it relates to a drug preparation that includes mesenchymal stem cells used to treat lung damage resulting from a respiratory infection.
Claim 15 uses the generic term “respiratory infection” as it relates to a drug preparation that includes mesenchymal stem cells used to treat lung damage resulting from a respiratory infection.
The specification provides antecedent basis for the generic term “respiratory infection” [¶ 0022].
Applicant’s specification states “the mesenchymal stem cells are particularly useful for lung damage caused by a respiratory infection” [Id.]. However, the term respiratory infection includes not just infections in the lungs. Per Wikipedia, respiratory tract infections include infections in both the upper and lower respiratory tracts. This includes areas such as the nasal cavity, pharynx, larynx, trachea, primary bronchi, and lungs [Wikipedia “Respiratory tract infection”, 2019]. Because of this, a person of ordinary skill would find it difficult to determine what other respiratory infections, not just lung infections, could be treated through the administration of mesenchymal stem cells.
Given the generic scope of “respiratory infection” as it relates to a drug preparation that includes mesenchymal stem cells used to treat lung damage resulting from a respiratory infection, and the absence of teachings of what other areas of the respiratory tract could also be treated by administering mesenchymal stem cells, an Artisan would not understand Applicant to be in possession of the generic scope of “respiratory infection” as it relates to treating respiratory infections through the administration of mesenchymal stem cells.
Claims 4, 1-3, 6-15, and 17-20 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.
Claim 4 uses the generic phrase “respiratory infection comprises viral pneumonia, bacterial pneumonia, or fungal infection” as it relates to treating such respiratory infections with a drug preparation that includes mesenchymal stem cells.
Claim 15 uses the generic phrase “respiratory infection comprises viral pneumonia, bacterial pneumonia, or fungal infection” as it relates to treating such respiratory infections with a drug preparation that includes mesenchymal stem cells.
The specification provides antecedent basis for “respiratory infection” as it relates to viral pneumonia, bacterial pneumonia or fungal infection where a drug preparation that includes mesenchymal stem cells is used for treating respective respiratory infection.
Applicant’s specification states that “respiratory infection comprises viral pneumonia, bacterial pneumonia or fungal infection” [¶ 0022]. The specification goes on to describe viral pneumonia as a severe or critical type of pneumonia caused by any one or more of coronavirus SARS-CoV-2, SARS-CoV or MERS-CoV [Id.]. However, the specification does not mention bacterial or fungal infection as it relates to a respiratory infection again. Paragraph [0022] is the only time these two types of infections are mentioned. There are no specific bacterial species or fungal species mentioned that are known to cause infections in persons or animals in general. In addition, Gao et al., discussing the potential use of mesenchymal stem cells as a therapeutic approach in fungal infections, discusses the current state of the art as it relates to using mesenchymal stem cells in the treatment of fungal infections [Therapeutic potential of mesenchymal stem cells for fungal infections: mechanisms, applications, and challenges, Front Microbiol, 2025]. Gao et al. goes on to illustrate how both human and mouse derived mesenchymal stem cells affect various species known to cause lung infections and the mechanisms in which these mesenchymal stem cells act on suppressing various aspects of fungal infections [Table 3]. For example, IL-17+ MSCs have been shown to significantly inhibit the growth of C. albicans most likely through the secretion of IL-17. Human MSCs displayed phagocytic properties on A. fumigatus spores but had no direct effect on hyphae 2. However, it was shown that mesenchymal stem cells, in other studies, showed an increase in fungal load when mesenchymal stem cells were transplanted in a model of P. brasiliensis and lead to an exacerbation of lung inflammation [Experimental evidence of the effects of MSCs on FIs ¶ 3]. Because of this, a person of ordinary skill would not have understood, given the current state of the art, that mesenchymal stem cells were a plausible treatment for the generic respiratory infections resulting from viral pneumonia, bacterial pneumonia or fungal infections.
Given the generic scope of “respiratory infection comprises viral pneumonia, bacterial pneumonia, or fungal infection” as it relates to treating such respiratory infections with a drug preparation that includes mesenchymal stem cells, and the absence of teachings as to how mesenchymal stem cells can be effective in treating “respiratory infection comprises viral pneumonia, bacterial pneumonia, or fungal infection”, an Artisan would not understand Applicant to be in possession of being able to treat respiratory infections resulting from viral pneumonia, bacterial pneumonia or fungal infections.
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 1-2, 5-6, 10, 12, 17, 19, and 20 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 1 recites the limitation "lung function" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites “the mesenchymal stem cells is useful”. The term “useful” is unclear in scope. Is “useful” referring to therapeutic efficacy, suitability for administration, ability to repair lung tissue, or some other function. Because of this, it is unclear what limitations are being claimed as it relates to administering mesenchymal stem cells to a subject.
Regarding claim 5, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 6 recites the limitation "human being" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation “bone tissue”, and the claim also recites “bone marrow tissue” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 10 recites the limitation "in physiological saline" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "lung function" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites “mammal who suffers from damage”. As written, this statement is unclear. Does “suffer” require a clinical diagnosis, observable symptoms, or any underlying pathological damage? A person of ordinary skill would not know how to determine what “suffer” means.
Claim 17 recites the limitation "human being" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 17, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 17 recites the broad recitation “bone tissue”, and the claim also recites “bone marrow tissue” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 19 recites the limitation "human being" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 19, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 19 recites the broad recitation “bone tissue”, and the claim also recites “bone marrow tissue” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 20 recites “more than about 98% by mass”. The phrase “more than about 98%” is unclear. The modifier “about” is unclear. Will a mass percentage as low as 95% work, or will can 97.5% work? Will 98.1% by mass work? As written, it would be unclear to a person ordinary skill in the art as to what the metes and bounds of the claim limitation is.
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 1-9 and 19-20 are rejected under 35 U.S.C. §102(a)(1) as being anticipated by Hu et al. [CN 2020 10114692, 2020-06-19].
Regarding claim 1, Hu et al. teaches use of mesenchymal stem cells in the preparation of a drug for repairing lung damage, wherein the lung damage comprises damage to lung in function and/or tissue [Abstract].
Regarding claim 2, Hu et al. teaches the use according to claim 1, wherein the mesenchymal stem cell is useful for a subject who suffers from lung damage caused by a respiratory infection [Abstract].
Regarding claim 3, Hu et al. teaches the use according to claim 1, wherein the lung damage comprises lung fibrosis [Para starting with “removing inhibits T lymphocyte proliferation”].
Regarding claim 4, Hu et al. teaches the use according to claim 3, wherein the respiratory infection comprises viral pneumonia, bacterial pneumonia or fungal infection [Abstract].
Regarding claim 5, Hu et al. teaches the use according to claim 4, wherein the viral pneumonia is a severe or critical type of pneumonia caused by any one or more of coronavirus SARS-CoV-2, SARS-CoV or MERS-CoV [Abstract].
Regarding claim 6, Hu et al. teaches the use according to claim 1, wherein the mesenchymal stem cells are derived from tissues from human being such as at least one of bone marrow tissue, adipose tissue, muscle tissue, reproductive tissue, skin tissue, bone tissue, and dental tissue, wherein the reproductive tissue comprises menstrual blood, amniotic membrane, amniotic fluid, or umbilical cord blood; or prepared by separation or induction of human cells [Abstract].
Regarding claim 7, Hu et al. teaches the use according to claim 1, wherein the mesenchymal stem cell is a homogenous composition or a mixed cell cluster comprising the mesenchymal stem cells [Para starting with “As a preference, the umbilical cord mesenchymal stem cell into cell suspension”].
Regarding claim 9, Hu et al. teaches the use of claim 1, wherein the drug for reparing lung damage is in a form of injection formulation [Abstract].
Regarding claim 19, Hu et al. teaches the use according to claim 1, wherein the mesenchymal stem cells are derived from tissues from human being such as at least one of bone marrow tissue, adipose tissue, muscle tissue, reproductive tissue, skin tissue, bone tissue, and dental tissue, wherein the reproductive tissue comprises menstrual blood, amniotic membrane, amniotic fluid, or umbilical cord blood; or prepared by separation or induction of human cells [Abstract].
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 11-18 are rejected under 35 U.S.C. §102(a)(1) as being anticipated by Hu et al. [CN 2020 10114692, 2020-06-19].
Regarding claim 11, Hu et al. teaches a method for repairing lung damage, comprising administering a mesenchymal stem cell to a subject with lung damage [Abstract].
Regarding claim 12, Hu et al. teaches the method according to claim 11, wherein the subject comprises a mammal who suffers from damage to lung in function and/or tissue [Abstract].
Regarding claim 13, Hu et al. teaches the method according to claim 12, wherein the damage to lung in function and/or tissue comprises lung damage caused by a respiratory infection [Abstract].
Regarding claim 14, Hu et al. teaches the method according to claim 12, wherein the lung damage comprises lung fibrosis [Para starting with “removing inhibits T lymphocyte proliferation and activity”].
Regarding claim 15, Hu et al. teaches the method according to claim 13, wherein the respiratory infection comprises viral pneumonia, bacterial pneumonia or fungal infection [Abstract].
Regarding claim 16, Hu et al. teaches the method according to claim 15, wherein the viral pneumonia is a severe or critical type of pneumonia caused by any one or more of coronavirus SARS-CoV-2, SARS-CoV or MERS-Cov [Abstract].
Regarding claim 17, Hu et al. teaches the method according to claim 11, wherein the mesenchymal stem cells are derived from tissues from human being such as bone marrow tissue, adipose tissue, muscle tissue, reproductive tissue, skin tissue, bone tissue, and dental tissue, wherein the reproductive tissue comprises menstrual blood, amniotic membrane, amniotic fluid, or umbilical cord blood; or prepared by separation or induction of human cells [Abstract].
Regarding claim 18, Hu et al. teaches the method according to claim 17, wherein the mesenchymal stem cell is a homogenous composition or a mixed cell cluster comprising mesenchymal stem cells [Para starting with “As a preference, the umbilical cord mesenchymal stem cell into cell suspension”].
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.
Claim 10 is rejected under 35 U.S.C. §103 as being unpatentable over Hu et al. [CN 2020 10114692, 2020-06-19], in view of Guo et al. [Administration of umbilical cord mesenchymal stem cells in patients with severe COVID-19 pneumonia, Crit Care, July 11, 2020].
Hu et al. teaches every element for claims 1-8.
However, Hu et al. does not teach suspension of mesenchymal stem cells in physiological saline at a cell concentration of 0.5 x 105 cells/mL to 5.0 x 105 cells/mL as stated in claim 10.
Regarding claim 10 where the drug for repairing lung damage is a suspension of mesenchymal stem cells in physiological saline at a cell concentration of 0.5 x 105 cells/mL to 5.0 x 105 cells/mL, Guo et al. teaches that the patients were treated according to national guidelines where prior to intravenous drip, the UC-MSCs (mesenchymal stem cells) at a concentration of 1 x 106 cells per kilogram of weight were suspended in 100 ml normal saline [¶ 2]. Here, the prior art is teaching the administration of mesenchymal stem cells to treat lung damage in a higher dose. However, it would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to modify the systems and methods according to Hu et al. combined with Guo et al. where an Artisan would adjust the dose from the higher concentration to the lower claimed range in order to optimize the therapeutic effect and reduce any potential side effects such as aggregation or immune reactions. This adjustment would be considered routine optimization. Because of this, there is a reasonable expectation of success that a person of ordinary skill in the art would adjust dosage concentration based on the teachings of both Hu et al. and Guo et al. in order to obtain an optimal therapeutic effect on a subject.
The Supreme court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable varition..103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions…
…the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) emphasis added.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims allowed.
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/JOHN DAVID MOORE/Examiner, Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638