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 .
Status of the Claims
This action is in response to the communication of 8/14/2023
Claims 1-15 are pending.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claims 10, 13 , and 14 are objected to because of the following informalities: minor grammatical errors for example they should read as “the immature dendritic cells are administered”. 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 4, 6, 7, 10, 13, and 14 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.
Regarding claim 4, The term “reducing cognitive decline” is a relative term which renders the claim indefinite. The term “reducing cognitive decline” 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.
Regarding claim 6, The term “decreases pulmonary stem cell regenerative activity” is a relative term which renders the claim indefinite. The term “decreases pulmonary stem cell regenerative activity” 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.
Regarding claim 7, Claim 7 recites the limitation "the cells". There is insufficient antecedent basis for this limitation in the claim. It isn’t clear what cells are being referred to. For purposes of examination, this will be interpreted as if the apoptotic bodies of claim 4 were apoptotic cells, and the apoptotic cells were pretreated with interferon gamma.
Regarding claim 10, 13 , and 14, these claims include the term “..is administered, or is for administration…”. It is not clear what the meaning of this term is in the scope of the claim. Does this mean that the immature dendritic cells can simply be intended to be administered, but not actually administered?
For example, claim 10 could be interpreted as “Claim 9…administering …immature dendritic cells to a patient…Claim 10..wherein the immature dendritic cell is for administration before, after, or simultaneously with apoptotic bodies”. Does this mean that the cells could just be labeled as “for administration” and not actually administered? This wouldn’t make sense since the dependent claim 9 requires the administration of the dendritic cells.
In other words, if the term “or is for administration” were simply deleted it does not appear that the meaning of the claims would change at all, so it is not clear what the intended meaning of this optional limitation would be. Thus they are indefinite.
Regarding Claim 14, Claim 14 includes the term “standard COPD therapy”. No definition of this therapy is provided. A search of the prior art reveals that there is a wide variety of COPD therapies available, and it is not clear what is meant to be the “standard” therapy, or who’s standard is referred to. For the purposes of examination, any treatment method for COPD will be considered to be a “standard COPD therapy.”
Claim interpretation, preambles not limiting.
Regarding claim 1, the preamble of “a method for preventing or reducing COPD in a patient, the method comprising…” merely recites an intended result of the administration of the apoptotic bodies, with not is not given patentable weight since the body of the claim sets forth a complete invention (administration of apoptotic bodies).
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See also Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003) (In considering the effect of the preamble in a claim directed to a method of treating or preventing pernicious anemia in humans by administering a certain vitamin preparation to "a human in need thereof," the court held that the claims’ recitation of a patient or a human "in need" gives life and meaning to the preamble’s statement of purpose.)
A suggested remedy would be to add the “a method for preventing or reducing COPD in a subject in need thereof, the method comprising….bodies to a subject in need thereof. To claim 1.
Regarding claim 14, the preamble of “a method for reducing…, the method comprising…” merely recites an intended result of the administration of apoptotic bodies, with not is not given patentable weight since the body of the claim sets forth a complete invention (administration of apoptotic bodies). The limitation of “after exposure of said patient to said inflammatory inflammatory trigger” does appear in the claim body and is limiting on the claim. So technically the patentable weight of claim 14 is “A method comprising administering a therapeutically effective amount of apoptotic bodies derived from one or more cell populations to a patient after exposure of said patient to an inflammatory trigger.
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.
Maddens
Claims 1-6, 14 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Maddens FR2980710A1
As evidenced by Bittencourt, Marcelo de Carvalho, et al. "Intravenous injection of apoptotic leukocytes enhances bone marrow engraftment across major histocompatibility barriers." Blood, The Journal of the American Society of Hematology 98.1 (2001): 224-230.
As evidenced by Chen L, Deng H, Cui H, Fang J, Zuo Z, Deng J, Li Y, Wang X, Zhao L. Inflammatory responses and inflammation-associated diseases in organs. Oncotarget. 2017 Dec 14;9(6):7204-7218
Regarding claim 1, Maddens teaches a composition comprising apoptotic and non-apoptotic mesenchymal stem cells (MSC). (Maddens translation, Abstract). Maddens teaches that their composition comprising apoptotic MSC may be used to treat a variety of diseases, including inflammatory lung diseases, including specifically COPD. (Maddens translation, pg. 4, second to last paragraph.).
Regarding claim 2, Maddens teaches that several methods of inducing apoptosis can be used, with one method of generating apoptotic cells being to irradiate them, referring to Bittencourt, which irradiates apoptotic leukocytes under serum-free conditions. (Maddens translation, pg. 5, second to last paragraph.), (Bittencourt, Abstract, Apoptosis induction section)
Regarding claim 3, Maddens teaches that one method of generating apoptotic cells is to deprive the cells in serum culture. (Maddens, pg. 4, third para. Starting with “One method is to…”)
Regarding claim 4, Maddens teaches the administration of apoptotic MSC to treat COPD. For purposes of examination, an “inflammatory trigger” is not given a limiting definition in the specification. Some preferred embodiments are listed in paragraph [0054] of the specification, but otherwise the term “inflammatory trigger” must be given the broadest reasonable interpretation. Inflammation is known in the art as biological response of the immune system that can be triggered by a variety of factors, including pathogens, damaged cells and toxic compounds. (Chen, Abstract). In this case, “inflammatory trigger” would be any possible trigger of any inflammation in a patient at any time of their lives prior to treatment with apoptotic MSC.
As discussed in MPEP § 2112, citing In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594), the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). In the instant case, there is reason to believe that Madden’s method of treating COPD with apoptotic bodies includes the cases where a subject was suffering from COPD, since virtually every patient would have been exposed to some kind of inflammatory trigger at some point of their lives prior to treatment. COPD is itself an inflammatory disease, i.e. such a patient has necessarily been “exposed to an inflammatory trigger” by suffering from COPD itself.
Regarding claim 5, 6, and 15, As discussed in MPEP § 2112, citing In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594), the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). In the instant case, there is reason to believe that Madden’s method would treat COPD when associated with an infection, since Maddens teaches every limitation of the claimed method. That is, Maddens teaches every limitation of the claimed method, so it is reasonable that Maddens’ administration of apoptotic MSC would treat COPD associated with an infection, or where the infection has the effect of decreasing pulmonary stem cell regenerative activity, or or where the subject has lung scarring, or essentially any other complication as well since Maddens treatment method is indistinguishable from the claimed method.
Further regarding claims 5, 6, and 15 these claims recite limitations in “wherein” clauses for conditions the patient may have in addition to COPD. In accordance with MPEP 2111.04, “adapted to/for”, “wherein”, and “whereby” clauses “may raise a question as to the limiting effect of the language in a claim” and the “determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case.” The same section cites Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) in finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps" as being inherent (e.g. the case wherein a particular point mutation inherently indicated an increased risk for thrombosis). Further, the same section cites Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), where the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Here, the wherein/whereby clause was found to contain a positive limitation, whose omission would have altered the scope of the invention (e.g. it specifically allowed for interactive data messaging in the claim). In contrast, the same MPEP section states that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited’" quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003).
The instant claims similarly recite the intended result of treatment of COPD associated with certain infections and complications resulting from process steps positively recited of administering apoptotic bodies to a patient. Therefore, the limitations do not distinguish over the prior art.
Regarding claim 14, For claim interpretation, the “before commencement of COPD therapy” does not technically require that standard COPD therapy ever must actually take place, or a timeline for when standard therapy must begin, only that apoptotic bodies are administered before the therapy. Thus, any administration of apoptotic bodies to a subject that has not yet started, and may never start standard COPD therapy would read on claim 14.
Maddens teaches that several methods of inducing apoptosis can be used, with one method of generating apoptotic cells being to irradiate them, referring to Bittencourt, which irradiates apoptotic leukocytes under serum-free conditions. (Maddens translation, pg. 5, second to last paragraph.), (Bittencourt, Abstract, Apoptosis induction section). Maddens does not specify that the COPD patient had yet been treated with standard COPD therapy. Thus, Maddens teaches administration of apoptotic MSC before commencement of standard COPD therapy.
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.
Maddens and Pang
Claims 1-7, 14 and 15 rejected under 35 U.S.C. 103 as being unpatentable over:
Maddens FR2980710A1
Pang (Pang, Swee Heng Milon, et al. "Mesenchymal stromal cell apoptosis is required for their therapeutic function." Nature communications 12.1 (2021): 6495.)
Claims 1-6, 14 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maddens
Regarding claim 7, Maddens teaches that several methods of inducing apoptosis in MSC can be used, but does not specify that the cells may be treated with interferon gamma specifically. (Maddens, pg. 5. Second to last para.). Pang teaches that it was known in the art that inferferon gamma may induce apoptosis of MSC. Specifically “many of the stimuli reported to license MSCs (e.g. IFN-γ, TNF-α and toll-like receptor activation) can also induce apoptosis” (Pang, second to last paragraph).
It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date of the application to use interferon gamma to induce apoptosis as taught by Pang as a method of generating apoptotic MSC in Maddens. One of ordinary skill in the art would have been motivated to do so, since the choice of an apoptosis method is combining prior art elements according to known methods to yield predictable results. (MPEP 2143 (I)(A)). Maddens offers several options for inducing their MSC to undergo apoptosis. The skilled artisan would be reasonably apprised of alternative methods that are not listed to reach a similar effect, namely the generation of an apoptotic cell and more specifically an apoptotic MSC. Pang notes that it is known in the art that MSC specifically are sensitive to interferon gamma exposure and that such exposure can induce them to undergo apoptosis.
One of ordinary skill in the art would have had a reasonable expectation of success, since Pang teaches that interferon gamma exposure can cause apoptosis in MSC specifically, and Maddens is concerned with inducing apoptosis in MSC.
Maddens, Pang, and Ribeiro-Paes
Claims 1-11, 14 and 15 rejected under 35 U.S.C. 103 as being unpatentable over:
Maddens FR2980710A1
Pang Pang, Swee Heng Milon, et al. "Mesenchymal stromal cell apoptosis is required for their therapeutic function." Nature communications 12.1 (2021): 6495
Ribeiro-Paes, João Tadeu, et al. "Unicentric study of cell therapy in chronic obstructive pulmonary disease/pulmonary emphysema." International journal of chronic obstructive pulmonary disease (2011): 63-71.
As evidenced by Srivastava S, Jackson C, Kim T, Choi J, Lim M. A Characterization of Dendritic Cells and Their Role in Immunotherapy in Glioblastoma: From Preclinical Studies to Clinical Trials. Cancers (Basel). 2019 Apr 15;11(4):537
As evidenced by Cuende, Natividad, Laura Rico, and Concha Herrera. "Concise review: bone marrow mononuclear cells for the treatment of ischemic syndromes: medicinal product or cell transplantation?." Stem cells translational medicine 1.5 (2012): 403-408.
As evidenced by Sun Z, Li F, Zhou X, Chung KF, Wang W, Wang J. Stem cell therapies for chronic obstructive pulmonary disease: current status of pre-clinical studies and clinical trials. J Thorac Dis. 2018 Feb;10(2):1084-1098
Claims 1-7, 14 and 15 rejected under 35 U.S.C. 103 as being unpatentable over Maddens and Pang
Regarding claim 8-11, Maddens and Pang teach the method of claim 7, but are silent regarding the additional administration of immature dendritic cells to treat COPD.
Ribeiro-Paes teaches the administration of BBMC to treat COPD. (Riberiro-Paes, Abstract). BMMCs are heterogeneous cells that include lymphocytes, monocytes, hematopoietic progenitor cells (HPCs), and MSCs (Cuende, introduction) (Sun, pg. 1089, first paragraph). The HPC is the progenitor cell for all dendritic cell populations. (Srivastava, Fig. 1). Thus, an HPC is properly considered an “immature dendritic cell”. So, Riberio-Paes teaches the administration of a mixture of MSC and immature dendritic cells.
Thus, Maddens and Pang teach a composition for treating COPD comprising apoptotic cells that have been pretreated with interferon gamma, and Ribeiro-Paes teaches a composition for treating COPD comprising immature dendritic cells. Thus, the prior art teaches two compositions useful for treatment of COPD, and claim 8 includes a limitation to combine these two compositions.
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Borrelli
Claims 1, 4-6, 9-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over:
Borrelli, Emma, and Velio Bocci. "Oxygen ozone therapy in the treatment of chronic obstructive pulmonary disease: an integrative approach." Am J Clin Exp Med 2.2 (2014): 29-13.
As evidenced by Chen L, Deng H, Cui H, Fang J, Zuo Z, Deng J, Li Y, Wang X, Zhao L. Inflammatory responses and inflammation-associated diseases in organs. Oncotarget. 2017 Dec 14;9(6):7204-7218
As evidenced by Jamal A, Khan MT, Parveen S, Rizvi Q, Farzana T, Zaidi U, Borhany M, Siddiqui S, Ansari SH, Shamsi TS. Peripheral Blood Stem Cell Harvest HPC Count Is an Effective Surrogate Marker for CD34+ Cell Count in Allogeneic Stem Cell Transplant Setting. Transl Oncol. 2020 Jul;13(7):100788
As evidenced by Srivastava S, Jackson C, Kim T, Choi J, Lim M. A Characterization of Dendritic Cells and Their Role in Immunotherapy in Glioblastoma: From Preclinical Studies to Clinical Trials. Cancers (Basel). 2019 Apr 15;11(4):537
As evidenced by du Plessis, Lissinda H., Francois H. van der Westhuizen, and Herculaas F. Kotze. "The effect of blood ozonation on mitochondrial function and apoptosis of peripheral blood mononuclear cells in the presence and absence of plasma antioxidants." African Journal of Biotechnology 6.15 (2007).
Regarding claim 1, Borelli teaches a method of treating COPD with ozonated autohaemotherapy. (Borelli, Abstract). In other words, Borelli removed blood from a subject, mixed the blood with ozone gas outside the body, and re-infused the ozonated blood/ blood and ozone gas mixture back to the subject. If the ozonation process apoptotic bodies in the blood, or if the blood already had apoptotic bodies naturally prior to re-administration, this process would reasonably read on claim 1.
Du Plessis teaches that blood ozonation at typical ozone-autohemotherapy levels induces apoptosis of peripheral blood mononuclear cells, i.e., generates apoptotic cells/apoptotic bodies in the blood. (Du Plessis, Title, Abstract, Introduction).
As discussed in MPEP § 2112, citing In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594), the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). In the instant case, there is reason to believe that Borelli administered apoptotic bodies to a subject as part of a method for treating COPD, since while Borelli does not explicitly point out that their process generates apoptotic bodies, it was known in the art that the ozonation of blood does produce at least some amount of apoptotic bodies/apoptotic PBMC.
Borelli anticipates claim 1.
Regarding claim 4, Borelli teaches the administration of apoptotic bodies to treat COPD. For purposes of examination, an “inflammatory trigger” is not given a limiting definition in the specification. Some preferred embodiments are listed in paragraph [0054] of the specification, but otherwise the term “[the] patient has been exposed to an inflammatory trigger” must be given the broadest reasonable interpretation. Inflammation is known in the art as biological response of the immune system that can be triggered by a variety of factors, including pathogens, damaged cells and toxic compounds. (Chen, Abstract). In this case, “[the] patient has been exposed to an inflammatory trigger” must include any possible trigger of any level of inflammation in a patient at any time of their lives prior to treatment with apoptotic bodies.
As discussed in MPEP § 2112, citing In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594), the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). In the instant case, there is reason to believe that Borelli’s method of treating COPD with apoptotic bodies includes the cases where a subject was suffering from COPD, since virtually every patient would have been exposed to some kind of inflammatory trigger at some point of their lives prior to treatment. COPD is also itself an inflammatory disease, i.e. such a patient has necessarily been “exposed to an inflammatory trigger” by suffering from COPD itself.
Regarding claim 5, 6, and 15, As discussed in MPEP § 2112, citing In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594), the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). In the instant case, there is reason to believe that Borelli’s method would treat COPD when associated with an infection, since Borelli teaches every limitation of the claimed method. That is, Borelli teaches every limitation of the claimed method, so it is reasonable that Borelli’s administration of apoptotic cells would treat COPD associated with an infection, or where the infection has the effect of decreasing pulmonary stem cell regenerative activity, or where the subject has lung scarring, or essentially any other complication as well since Borelli’s treatment method is indistinguishable from the claimed method.
Further regarding claims 5, 6, and 15 these claims recite limitations in “wherein” clauses for conditions the patient may have in addition to COPD. In accordance with MPEP 2111.04, “adapted to/for”, “wherein”, and “whereby” clauses “may raise a question as to the limiting effect of the language in a claim” and the “determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case.” The same section cites Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) in finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps" as being inherent (e.g. the case wherein a particular point mutation inherently indicated an increased risk for thrombosis). Further, the same section cites Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), where the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Here, the wherein/whereby clause was found to contain a positive limitation, whose omission would have altered the scope of the invention (e.g. it specifically allowed for interactive data messaging in the claim). In contrast, the same MPEP section states that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited’" quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003).
The instant claims similarly recite the intended result of treatment of COPD associated with certain infections and complications resulting from process steps positively recited of administering apoptotic bodies to a patient. Therefore, the limitations do not distinguish over the prior art.
Regarding claim 9, Blood naturally comprises hematopoietic progenitor cells (HPC) (Jamal, title abstract) which are immature dendritic cells (Srivatsa, Fig 1).
Regarding claim 10 and 11, the ozonated blood and all components including apoptotic cells, apoptotic bodies, and immature dendritic cells are administered to the patient simultaneously. (Borelli, Abstract, Introduction).
Regarding claim 12, The introduction of ozone gas to blood is reasonably expected to generate at least some apoptotic bodies. (Du Plessis, Title, Abstract, Introduction).
Regarding claim 13, Borelli teaches the mixture of blood and ozone gas, and then administers the mixture to the subject. (Borelli, Abstract, Introduction).
Conclusion
Claims 1-15 are rejected.
Claims 10, 13 , and 14 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS RUSSE AMICK whose telephone number is (571)272-5474. The examiner can normally be reached 7:30-5 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at (571) 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS R. AMICK/ Examiner, Art Unit 1638
/Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638