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 .
DETAILED ACTION
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 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.
Election/Restrictions
Applicant’s election without traverse of Invention I, claims 1-9 and 18-20, in the reply filed on Feb. 17, 2026 is acknowledged.
Claims 1-20 remain pending in the current application, claims 10-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
The requirement for the restriction of Inventions I-III is still deemed proper and is therefore made FINAL.
Claims 1-9 and 18-20 have been considered on the merits.
Status of the Claims
Claims 1-20 are currently pending.
Claims 10-17 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 1-9 and 18-20 have been considered on the merits.
Claim Objections
The disclosure is objected to because of the following informalities:
Claim 2 is objected to in the recitation of “a cell culture conditioned medium (CCM)”, and in the interest of improving claim form, it is suggested that the recited phrase be amended to recite “CCM”, since the acronym is already spelled out in claim 1.
Appropriate correction is appreciated.
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 1-9 and 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for promoting autophagy and/or proteasome activation of the skin in a subject by topically administering a cell cultured conditioned medium (CCM), does not reasonably provide enablement for the promotion of autophagy and/or proteasome activation in all organs or tissues using CCM from any cell type in any amount to any subject by any mode of administration. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, the enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method of promoting autophagy and/or proteasome activation in a subject by administering a CCM composition to the subject. Thus, the claims taken together with the specification imply that any kind of CCM produced by any cell type can promote autophagy and/or proteasome activation in any organ or tissue of any subject by administering any amount and by any mode.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The prior art in general teaches treating subjects with CCM compositions from particular cell types for particular purposes. For instance, Fong et al. (US 2015/0352157 A1) (ref. of record) a method of topically administering to a subject a cell culture conditioned medium to treat a wound (0004-0005). Fong teaches that conditioned medium from Human Wharton's Jelly stem cells (hWJSC-CM) and the lysate (hWJSC-CL) upregulate the expression of the autophagy-related genes BAX, ATG5, ATG7, and BECLIN-1 in human keloid cells in culture (0167). Sohn et al. (Dermatology and Therapy, 2018) (ref. of record) teaches a method of topically administering to a subject a cell culture conditioned medium (EPC-CM, epidermal progenitor cell-conditioned medium) to treat photoaged skin (abstract and pg. 233 Col. 2 para. 2-3). Thus, as the state of the art stands, the method would be unpredictable depending on the specific cell type used to generate the CCM, the particular subject, the condition being treated and the mode of administration.
(5) The relative skill of those in the art:
The relative skill of those in the art is high.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The instant specification provides no in vivo working examples and guidance for the use of the instantly claimed method for promoting autophagy and/or proteasome activation in a subject by administering a CCM composition to a subject. Example 1 of the specification describes a human 3D skin model treated with UV light to stimulate extrinsic gaining changes and the treating of the skin model with a CCM composition. The expression of genes associated with autophagy and proteasome activation were measured in a control treated model and the CCM treated model, and an increase in genes associated with autophagy and proteasome activation was found. There is no description of the particular CCM or source of the CCM used for the experiment or the concentration used. The specification does not provide additional guidance or support for the actual administration to a subject of a CCM composition. The applicants have provided no additional data demonstrating the claimed method with other potential subjects and or organs/tissues to give the skilled artisan any reason to expect that the method would be effective in promoting autophagy and/or proteasome activation in any subject by any mode of administering of any CCM composition to the subject.
Therefore, there is no conclusive evidence in the instant disclosure to indicate that the instantly claimed method can be used to promoting autophagy and/or proteasome activation in any subject by administering any CCM composition to the subject in any amount by any means.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed above and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to use the claimed invention within the broad scope as instantly claimed.
Claim Rejections - 35 USC § 112
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 18 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. Claim 18 includes the limitations of claim 8 from which it depends from (the composition is administered topically, orally or intravenously) and includes additional options for administration (the composition is administered by topical, oral, nasal, alveolar lavage, inhalation, intravenous or intracranial administration). In other words, claim 18 broadens the limitations of claim 8. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kellar et al. (Journal of Cosmetic Dermatology, 2009) (ref. of record).
With respect to claim 1, Kellar teaches a method of administering a cell culture conditioned medium composition to a subject (abstract pg. 191 Col. 2 para. 3-4). It is noted that Kellar does not teach that their method can be used in the manner instantly claimed for promoting autophagy and/or proteasome activation as recited in claim 1. However, Kellar teaches the claimed method of administering a CCM composition to a subject. Once administered to the subject the cells would treat whatever conditions are present. Thus, the claimed result of promoting autophagy and/or proteasome activation must be inherent to the method as taught by the references and a necessary effect of practicing the method.
With respect to claim 2, Kellar teaches the method where the CCM is produced by culturing cells in a suitable growth medium and where the cells produce and secrete a soluble fraction (CCM) (pg. 191 Col. 2 para. 3). With respect to claims 3 and 4, Kellar teaches the method where the cells are cultured under hypoxic conditions of 1-5% oxygen (pg. 191 Col. 2 Col. 3). With respect to claim 5, Kellar teaches the method where the cells are fibroblast cells (pg. 191 Col. 2 para. 3). With respect to claims 6 and 7, Kellar teaches the method where the cells are cultured in a three dimensional condition on dextran microcarrier beads (pg. 191 Col. 2 para. 3). With respect to claims 8 and 18, Kellar teaches the method where the CCM is administered topically (pg. 191 Col. 2 para. 2 and 4).
Although Kellar does not teaches that the method results in expression of ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof as recited in instant claim 9, this wherein clause recites an intended result of the method rather than requiring an additional step be performed. MPEP 2111.04 states “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” and that a such a clause ‘"in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Therefore since the claim only recite the results of the steps, then art reading on the method of claim 1 will also read on these results since performing the same steps will inherently lead to the same results in the absence of evidence to the contrary including unexpected results. Since, Kellar teaches the same step and method of claim 1, the result of increasing the expression of the proteins, ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof, should be inherent to practicing the method of Kellar.
Therefore, the reference anticipates the claimed subject matter.
Claims 1-9 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Naughton et al. (U.S. 8,535,913 B2) (ref. of record).
With respect to claim 1, Naughton teaches a method of administering a cell culture conditioned medium (CCM) composition to a subject (abstract, Col. 22 lines 10-13, Col. 28 lines 21-26). Naughton teaches the ECM (extracellular matrix) composition includes the soluble and non-soluble fractions where the soluble fraction is the cell-free supernatant and media (conditioned media) (Col. 21 lines 15-29).
It is noted that Naughton does not teach that their method can be used in the manner instantly claimed for promoting autophagy and/or proteasome activation as recited in claim 1. However, Naughton teaches the claimed method of administering a CCM composition to a subject. Once administered to the subject the cells would treat whatever conditions are present. Thus, the claimed result of promoting autophagy and/or proteasome activation must be inherent to the method as taught by the references and a necessary effect of practicing the method.
With respect to claim 2, Naughton teaches the method where the CCM is produced by culturing cells in a suitable growth medium and where the cells produce and secrete a soluble fraction (CCM) (Col. 3 lines 53-61). With respect to claims 3 and 4, Naughton teaches the method where the cells are cultured under hypoxic conditions of 1-5% oxygen (Col. 4 lines 5-13). With respect to claim 5, Naughton teaches the method where the cells are fibroblast cells (Col. 10 lines 48-56 and Col. 12 lines 34-40, 53-55). With respect to claims 6 and 7, Naughton teaches the method where the cells are cultured in a three dimensional condition on a scaffold, a mesh microcarrier beads (Col. 8 lines 39-43, Col. 10 lines 34-40, 48-53, Col. 11 lines 4-6, claims 11 and 12). With respect to claims 8 and 18, Naughton teaches the method where the CCM is administered topically and intravenously (Col. 23 lines 6-30 and claim 13).
Although Naughton does not teaches that the method results in expression of ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof as recited in instant claim 9, this wherein clause recites an intended result of the method rather than requiring an additional step be performed. MPEP 2111.04 states “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” and that a such a clause ‘"in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Therefore since the claim only recite the results of the steps, then art reading on the method of claim 1 will also read on these results since performing the same steps will inherently lead to the same results in the absence of evidence to the contrary including unexpected results. Since, Naughton teaches the same step and method of claim 1, the result of increasing the expression of the proteins, ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof, should be inherent to practicing the method of Naughton.
Therefore, the reference anticipates the claimed subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kellar et al. (Journal of Cosmetic Dermatology, 2009) (ref. of record) in view of Naughton et al. (U.S. 8,535,913 B2) (ref. of record) and Srivastava et al. (US 2006/0210549 A1).
With respect to claim 1, Kellar teaches a method of administering a cell culture conditioned medium composition to a subject (abstract pg. 191 Col. 2 para. 3-4). It is noted that Kellar does not teach that their method can be used in the manner instantly claimed for promoting autophagy and/or proteasome activation as recited in claim 1. However, Kellar teaches the claimed method of administering a CCM composition to a subject. Once administered to the subject the cells would treat whatever conditions are present. Thus, the claimed result of promoting autophagy and/or proteasome activation must be inherent to the method as taught by the references and a necessary effect of practicing the method.
With respect to claim 2, Kellar teaches the method where the CCM is produced by culturing cells in a suitable growth medium and where the cells produce and secrete a soluble fraction (CCM) (pg. 191 Col. 2 para. 3). With respect to claims 3 and 4, Kellar teaches the method where the cells are cultured under hypoxic conditions of 1-5% oxygen (pg. 191 Col. 2 Col. 3). With respect to claim 5, Kellar teaches the method where the cells are fibroblast cells (pg. 191 Col. 2 para. 3). With respect to claims 6 and 7, Kellar teaches the method where the cells are cultured in a three dimensional condition on dextran microcarrier beads (pg. 191 Col. 2 para. 3). With respect to claims 8 and 18, Kellar teaches the method where the CCM is administered topically (pg. 191 Col. 2 para. 2 and 4).
Although Kellar does not teaches that the method results in expression of ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof as recited in instant claim 9, this wherein clause recites an intended result of the method rather than requiring an additional step be performed. MPEP 2111.04 states “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” and that a such a clause ‘"in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Therefore since the claim only recite the results of the steps, then art reading on the method of claim 1 will also read on these results since performing the same steps will inherently lead to the same results in the absence of evidence to the contrary including unexpected results. Since, Kellar teaches the same step and method of claim 1, the result of increasing the expression of the proteins, ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof, should be inherent to practicing the method of Kellar.
Kellar does not teach the method where the CCM composition is administered in a nano-container conjugated to a targeting moiety for specific tissue delivery as recited in claim 19. Similarly, Kellar does not teach the method where the targeting moiety for specific tissue delivery is an aptamer, antibody, antibody fragment, peptide or affinity ligand that recognizes a tissue specific surface or internalization biomarker as recited in claim 20.
However, Naughton teaches a method of administering a cell culture conditioned medium (CCM) composition to a subject (abstract, Col. 22 lines 10-13, Col. 28 lines 21-26). Naughton further teaches the method where the conditioned media is formulated in a liposome (nano-container) to extend the life time of the active factors (Col. 22 lines 10-13).
In further support, Srivastava teaches liposome-encapsulated drugs with selective targeting moieties attached to the outer surface of the liposomes (0004 and 0014). Srivastava teaches that targeting protects key organs against toxicity from the drugs (0004). In addition, Srivastava teaches that the targeting moiety can be an antibody or a polypeptide (0004).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Kellar so that the CCM is formulated in a liposome with targeting moieties for the benefit of extending the life time of the active factors of the CCM, to have specific tissue delivery to avoid any off target side effects, and to deliver the CCM to the intended tissue as taught by Naughton and Srivastava. It would have been obvious to one of ordinary skill in the art to make such a modification to Kellar, since Naughton teaches encapsulating CCM in liposomes (nano-container) for tissue delivery and Srivastava teaches liposomes with targeting moieties including antibodies and polypeptides for tissue specific delivery. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to Kellar, since CCM was known to be encapsulated in nano-containers as taught by Naughton and liposomes were known to have targeting moieties for specific tissues such as antibodies and polypeptides as taught by Srivastava.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claims 1-9 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Naughton et al. (U.S. 8,535,913 B2) (ref. of record) in view of Srivastava et al. (US 2006/0210549 A1).
With respect to claim 1, Naughton teaches a method of administering a cell culture conditioned medium (CCM) composition to a subject (abstract, Col. 22 lines 10-13, Col. 28 lines 21-26). Naughton teaches the ECM (extracellular matrix) composition includes the soluble and non-soluble fractions where the soluble fraction is the cell-free supernatant and media (conditioned media) (Col. 21 lines 15-29).
It is noted that Naughton does not teach that their method can be used in the manner instantly claimed for promoting autophagy and/or proteasome activation as recited in claim 1. However, Naughton teaches the claimed method of administering a CCM composition to a subject. Once administered to the subject the cells would treat whatever conditions are present. Thus, the claimed result of promoting autophagy and/or proteasome activation must be inherent to the method as taught by the references and a necessary effect of practicing the method.
With respect to claim 2, Naughton teaches the method where the CCM is produced by culturing cells in a suitable growth medium and where the cells produce and secrete a soluble fraction (CCM) (Col. 3 lines 53-61). With respect to claims 3 and 4, Naughton teaches the method where the cells are cultured under hypoxic conditions of 1-5% oxygen (Col. 4 lines 5-13). With respect to claim 5, Naughton teaches the method where the cells are fibroblast cells (Col. 10 lines 48-56 and Col. 12 lines 34-40, 53-55). With respect to claims 6 and 7, Naughton teaches the method where the cells are cultured in a three dimensional condition on a scaffold, a mesh microcarrier beads (Col. 8 lines 39-43, Col. 10 lines 34-40, 48-53, Col. 11 lines 4-6, claims 11 and 12). With respect to claims 8 and 18, Naughton teaches the method where the CCM is administered topically and intravenously (Col. 23 lines 6-30 and claim 13).
Although Naughton does not teaches that the method results in expression of ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof as recited in instant claim 9, this wherein clause recites an intended result of the method rather than requiring an additional step be performed. MPEP 2111.04 states “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” and that a such a clause ‘"in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Therefore since the claim only recite the results of the steps, then art reading on the method of claim 1 will also read on these results since performing the same steps will inherently lead to the same results in the absence of evidence to the contrary including unexpected results. Since, Naughton teaches the same step and method of claim 1, the result of increasing the expression of the proteins, ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof, should be inherent to practicing the method of Naughton.
With respect to claim 19, Naughton teaches the conditioned media is formulated in a liposome (nano-container) to extend the life time of the active factors (Col. 22 lines 10-13). However, Naughton does not teach the method where the non-container is conjugated to a targeting moiety for specific tissue delivery as recited in claim 19. Similarly, Naughton does not teach the method where the targeting moiety for specific tissue delivery is an aptamer, antibody, antibody fragment, peptide or affinity ligand that recognizes a tissue specific surface or internalization biomarker as recited in claim 20.
However, Srivastava teaches liposome-encapsulated drugs with selective targeting moieties attached to the outer surface of the liposomes (0004 and 0014). Srivastava teaches that targeting protects key organs against toxicity from the drugs (0004). In addition, Srivastava teaches that the targeting moiety can be an antibody or a polypeptide (0004).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Naughton so that the CCM is formulated in a liposome with targeting moieties for the benefit of specific tissue delivery to avoid any off target side effects and to deliver the CCM to the intended tissue as taught by Srivastava. It would have been obvious to one of ordinary skill in the art to make such a modification to Naughton, since Naughton teaches encapsulating CCM in liposomes (nano-container) for tissue delivery and Srivastava teaches liposomes with targeting moieties including antibodies and polypeptides for tissue specific delivery. For these same reasons, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to Naughton.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp
Claims 1-3, 6-9, and 18 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 3 of copending Application No. 19/359318. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the copending patent application. In addition, both claim methods of administering a cell cultured conditioned medium (CCM) to a subject.
With respect to instant claim 1, claims 1 and 3 of Appl. No. 19/359318 recite a method of administering a cell culture conditioned medium (CCM) composition to a subject. It is noted the claims of Appl. No. 19/359318 do not recite that the method can be used in the manner instantly claimed for promoting autophagy and/or proteasome activation as recited in claim 1. However, the claims of Appl. No. 19/359318 recite the claimed method of administering a CCM composition to a subject. Once administered to the subject the cells would treat whatever conditions are present. Thus, the claimed result of promoting autophagy and/or proteasome activation must be inherent to the method as taught by the references and a necessary effect of practicing the method.
Claim 1 of Appl. No. 19/359318 recites the limitations of instant claim 2, where the CCM is produced by culturing cells in a suitable growth medium and where the cells produce and secrete a CCM. Claim 1 of Appl. No. 19/359318 recites the limitations of instant claim 3, where the cells are cultured under hypoxic or normoxic conditions. Claim 3 of Appl. No. 19/359318 recites the limitations of instant claim 8, where the CCM is administered topically. Claim 3 of Appl. No. 19/359318 recites the limitations of instant claim 18, where the CCM is administered by topical administration. Although, the claims of Appl. No. 19/359318 recites do not explicitly state that the cells are grown under one, two or three dimensional culture conditions as recited in claim 6, the culturing inherently has to be one of these dimensions. Although, the claims of Appl. No. 19/359318 do not explicitly state that the cells are grown under one, two or three dimensional culture conditions as recited in claim 6, the culturing inherently has to be in one of these dimensions. Additionally, the claims of Appl. No. 19/359318 recites do not explicitly state that the cells are grown in a monolayer, on beads or on mesh as recited in claim 7, the culturing inherently has to be performed under one of these conditions or alternatively, these are well-known culturing systems.
Although the claims of Appl. No. 19/359318 do not recite that the method results in expression of ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof as recited in instant claim 9, this wherein clause recites an intended result of the method rather than requiring an additional step be performed. MPEP 2111.04 states “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” and that a such a clause ‘"in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Therefore since the claim only recite the results of the steps, then claims reading on the method of claim 1 will also read on these results since performing the same steps will inherently lead to the same results in the absence of evidence to the contrary including unexpected results. Since, the claims of Appl. No. 19/359318 recites the same step and method of claim 1, the result of increasing the expression of the proteins, ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof, should be inherent to practicing the method of Appl. No. 19/359318.
This is a provisional nonstatutory double patenting rejection.
Claims 4 and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of copending Application No. 19/359318 in view of Naughton et al. (U.S. 8,535,913 B2) (ref. of record).
As stated in the nonstatutory double patenting rejection above, although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the copending patent application. In addition, both claim methods of administering a cell cultured conditioned medium (CCM) to a subject. With respect to instant claim 1, claims 1 and 3 of Appl. No. 19/359318 recite a method of administering a cell culture conditioned medium (CCM) composition to a subject.
The claims of Appl. No. 19/359318 do not teach instant claim 4, where the hypoxic conditions comprises 1-5% oxygen. However, Naughton teaches a similar method where the CCM is made from cells grown under hypoxic conditions where the oxygen is 1-5% (Col. 4 lines 5-13). It would have been obvious to modify the method recited by of Appl. No. 19/359318 to use or include the known hypoxic levels of 1-5% oxygen as taught by Naughton. One of ordinary skill in the art would reasonable predict success in making such a modification, since these levels were known to produce CCM for treating.
The claims of Appl. No. 19/359318 do not teach the limitations of instant claim 5, where the cells are fibroblast cells. However, Naughton teaches the method where the cells are fibroblast cells (Col. 10 lines 48-56 and Col. 12 lines 34-40, 53-55). Accordingly, it would have been obvious to one of ordinary skill in the art use other known cell types in a method of treating with CCM such as fibroblasts. Such a modification merely involves the substitution of one known cell type for another for the production of CCM for treatment.
This is a provisional nonstatutory double patenting rejection.
Claims 19 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of copending Application No. 19/359318 in view of Naughton et al. (U.S. 8,535,913 B2) (ref. of record) and Srivastava et al. (US 2006/0210549 A1).
As stated in the nonstatutory double patenting rejection above, although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the copending patent application. In addition, both claim methods of administering a cell cultured conditioned medium (CCM) to a subject. With respect to instant claim 1, claims 1 and 3 of Appl. No. 19/359318 recite a method of administering a cell culture conditioned medium (CCM) composition to a subject.
The claims of Appl. No. 19/359318 do not teach instant claim 19, where the CCM composition is administered in a nano- container conjugated to a targeting moiety for specific tissue delivery. The claims of Appl. No. 19/359318 do not teach instant claim 20, where the targeting moiety for specific tissue delivery is an aptamer, antibody, antibody fragment, peptide or affinity ligand that recognizes a tissue specific surface or internalization biomarker.
However, Naughton teaches a method of administering a cell culture conditioned medium (CCM) composition to a subject (abstract, Col. 22 lines 10-13, Col. 28 lines 21-26). Naughton further teaches the method where the conditioned media is formulated in a liposome (nano-container) to extend the life time of the active factors (Col. 22 lines 10-13). In further support, Srivastava teaches liposome-encapsulated drugs with selective targeting moieties attached to the outer surface of the liposomes (0004 and 0014). Srivastava teaches that targeting protects key organs against toxicity from the drugs (0004). In addition, Srivastava teaches that the targeting moiety can be an antibody pr a polypeptide (0004).
Accordingly, one of ordinary skill in the art would have been motivated to modify the method of Appl. No. 19/359318 so that the CCM is formulated in a liposome with targeting moieties for the benefit of extending the life time of the active factors of the CCM, to have specific tissue delivery to avoid any off target side effects, and to deliver the CCM to the intended tissue as taught by Naughton and Srivastava. It would have been obvious to one of ordinary skill in the art to make such a modification to Appl. No. 19/359318, since Naughton teaches encapsulating CCM in liposomes (nano-container) for tissue delivery and Srivastava teaches liposomes with targeting moieties including antibodies and polypeptides for tissue specific delivery. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to Appl. No. 19/359318, since CCM was known to be encapsulated in nano-containers as taught by Naughton and liposomes were known to have targeting moieties for specific tissues such as antibodies and polypeptides as taught by Srivastava.
This is a provisional nonstatutory double patenting rejection.
Claims 1-7, and 9 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 21 of copending Application No. 17/393356.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the copending patent application. In addition, both claim methods of administering a cell cultured conditioned medium (CCM) to a subject.
With respect to instant claim 1, claims 1 and 21 of Appl. No. 17/393356 recite a method of administering a cell culture conditioned medium (CCM) composition to a subject. It is noted the claims of Appl. No. 17/393356 do not recite that the method can be used in the manner instantly claimed for promoting autophagy and/or proteasome activation as recited in claim 1. However, the claims of Appl. No. 17/393356 recite the claimed method of administering a CCM composition to a subject. Once administered to the subject the cells would treat whatever conditions are present. Thus, the claimed result of promoting autophagy and/or proteasome activation must be inherent to the method as taught by the references and a necessary effect of practicing the method.
Claim 21 of Appl. No. 17/393356 recites the limitations of claim 2, where the CCM is produced by culturing cells in a suitable growth medium and where the cells produce and secrete a CCM. Claim 21 of Appl. No. 17/393356 recites the limitations of claims 3 and 4, where the cells are cultured under hypoxic conditions of 1-5% oxygen. Claim 21 of Appl. No. 17/393356 recites the limitations of claim 5, where the cells are fibroblast cells. Claim 21 of Appl. No. 17/393356 recites the limitations of claims 6 and 7, where the cells are cultured in a three dimensional condition on microcarrier beads.
Although the claims of Appl. No. 17/393356 do not recite that the method results in expression of ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof as recited in instant claim 9, this wherein clause recites an intended result of the method rather than requiring an additional step be performed. MPEP 2111.04 states “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” and that a such a clause ‘"in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Therefore since the claim only recite the results of the steps, then claims reading on the method of claim 1 will also read on these results since performing the same steps will inherently lead to the same results in the absence of evidence to the contrary including unexpected results. Since, the claims of Appl. No. 17/393356 recites the same step and method of claim 1, the result of increasing the expression of the proteins, ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof, should be inherent to practicing the method of Appl. No. 17/393356.
This is a provisional nonstatutory double patenting rejection.
Claims 8 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 21 of copending Application No. 17/393356 in view of Naughton et al. (U.S. 8,535,913 B2) (ref. of record). As stated in the nonstatutory double patenting rejection above, although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the copending patent application. In addition, both claim methods of administering a cell cultured conditioned medium (CCM) to a subject. With respect to instant claim 1, claims 1 and 21 of Appl. No. 17/393356 recite a method of administering a cell culture conditioned medium (CCM) composition to a subject.
The claims of Appl. No. 17/393356 do not teach instant claim 8, where the CCM is administered topically, orally or intravenously. Similarly, The claims of Appl. No. 17/393356 do not teach instant claim 18, where the CCM is administered by topical, oral, nasal, alveolar lavage, inhalation, intravenous or intracranial administration.
However, Naughton teaches a method of administering a cell culture conditioned medium (CCM) composition to a subject (abstract, Col. 22 lines 10-13, Col. 28 lines 21-26). Naughton teaches the method where the CCM is administered topically and intravenously (Col. 23 lines 6-30 and claim 13). Accordingly, it would have been obvious to one of ordinary skill in the art use known methods of administering a CCM to a subject in a method of treating with CCM such as topically and intravenously as taught by Naughton. Such a modification to the method recited in the claims of Appl. No. 17/393356 would have had a reasonable expectation of success, since CCM was known to be administered by these mechanisms for treatment purposes.
This is a provisional nonstatutory double patenting rejection.
Claims 19 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 21 of copending Application No. 17/393356 in view of Naughton et al. (U.S. 8,535,913 B2) (ref. of record) and Srivastava et al. (US 2006/0210549 A1). As stated in the nonstatutory double patenting rejection above, although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the copending patent application. In addition, both claim methods of administering a cell cultured conditioned medium (CCM) to a subject. With respect to instant claim 1, claims 1 and 21 of Appl. No. 17/393356 recite a method of administering a cell culture conditioned medium (CCM) composition to a subject.
The claims of Appl. No. 17/393356 do not teach instant claim 19, where the CCM composition is administered in a nano- container conjugated to a targeting moiety for specific tissue delivery. The claims of Appl. No. 17/393356 do not teach instant claim 20, where the targeting moiety for specific tissue delivery is an aptamer, antibody, antibody fragment, peptide or affinity ligand that recognizes a tissue specific surface or internalization biomarker.
However, Naughton teaches a method of administering a cell culture conditioned medium (CCM) composition to a subject (abstract, Col. 22 lines 10-13, Col. 28 lines 21-26). Naughton further teaches the method where the conditioned media is formulated in a liposome (nano-container) to extend the life time of the active factors (Col. 22 lines 10-13). In further support, Srivastava teaches liposome-encapsulated drugs with selective targeting moieties attached to the outer surface of the liposomes (0004 and 0014). Srivastava teaches that targeting protects key organs against toxicity from the drugs (0004). In addition, Srivastava teaches that the targeting moiety can be an antibody or a polypeptide (0004).
Accordingly, one of ordinary skill in the art would have been motivated to modify the method of Appl. No. 17/393356 so that the CCM is formulated in a liposome with targeting moieties for the benefit of extending the life time of the active factors of the CCM, to have specific tissue delivery to avoid any off target side effects, and to deliver the CCM to the intended tissue as taught by Naughton and Srivastava. It would have been obvious to one of ordinary skill in the art to make such a modification to Appl. No. 17/393356, since Naughton teaches encapsulating CCM in liposomes (nano-container) for tissue delivery and Srivastava teaches liposomes with targeting moieties including antibodies and polypeptides for tissue specific delivery. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to Appl. No. 17/393356, since CCM was known to be encapsulated in nano-containers as taught by Naughton and liposomes were known to have targeting moieties for specific tissues such as antibodies and polypeptides as taught by Srivastava.
This is a provisional nonstatutory double patenting rejection.
Claims 1-9 and 18 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 11-13 of U.S. Patent No. 8,535,913. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the issue patent. In addition, both claim methods of administering a cell cultured conditioned medium (CCM) to a subject.
With respect to instant claim 1, claims 11 and 12 of U.S. Patent No. 8,535,913 recite a method of administering a cell culture conditioned medium (CCM) composition to a subject. It is noted the claims of U.S. Patent No. 8,535,913 do not recite that the method can be used in the manner instantly claimed for promoting autophagy and/or proteasome activation as recited in claim 1. However, the claims of U.S. Patent No. 8,535,913 recite the claimed method of administering a CCM composition to a subject. Once administered to the subject the cells would treat whatever conditions are present. Thus, the claimed result of promoting autophagy and/or proteasome activation must be inherent to the method as taught by the references and a necessary effect of practicing the method.
Claims 11 and 12 of U.S. Patent No. 8,535,913 recites the limitations of instant claim 2, where the CCM is produced by culturing cells in a suitable growth medium and where the cells produce and secrete a CCM. Claims 11 and 12 of U.S. Patent No. 8,535,913 recites the limitations of instant claims 3 and 4, where the cells are cultured under hypoxic conditions of 1-5% oxygen. Claims 11 and 12 of U.S. Patent No. 8,535,913 recites the limitations of claim 5, where the cells are fibroblast cells. Claims 11 and 12 of U.S. Patent No. 8,535,913 recites the limitations of instant claims 6 and 7, where the cells are cultured in a three dimensional condition on microcarrier beads. Claim 13 of U.S. Patent No. 8,535,913 recites the limitations of instant claims 8 and 18, where the CCM is administered topically.
Although the claims of U.S. Patent No. 8,535,913 do not recite that the method results in expression of ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof as recited in instant claim 9, this wherein clause recites an intended result of the method rather than requiring an additional step be performed. MPEP 2111.04 states “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” and that a such a clause ‘"in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Therefore since the claim only recite the results of the steps, then claims reading on the method of claim 1 will also read on these results since performing the same steps will inherently lead to the same results in the absence of evidence to the contrary including unexpected results. Since, the claims of U.S. Patent No. 8,535,913 recites the same step and method of claim 1, the result of increasing the expression of the proteins, ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof, should be inherent to practicing the method of U.S. Patent No. 8,535,913.
Claims 19 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-13 of U.S. Patent No. 8,535,913 in view of Naughton et al. (U.S. 8,535,913 B2) (ref. of record) and Srivastava et al. (US 2006/0210549 A1). As stated in the nonstatutory double patenting rejection above, although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the copending patent application. In addition, both claim methods of administering a cell cultured conditioned medium (CCM) to a subject. With respect to instant claim 1, claims 11 and 12 of U.S. Patent No. 8,535,913 recite a method of administering a cell culture conditioned medium (CCM) composition to a subject.
The claims of U.S. Patent No. 8,535,913 do not teach instant claim 19, where the CCM composition is administered in a nano- container conjugated to a targeting moiety for specific tissue delivery. The claims of U.S. Patent No. 8,535,913 do not teach instant claim 20, where the targeting moiety for specific tissue delivery is an aptamer, antibody, antibody fragment, peptide or affinity ligand that recognizes a tissue specific surface or internalization biomarker.
However, Naughton teaches a method of administering a cell culture conditioned medium (CCM) composition to a subject (abstract, Col. 22 lines 10-13, Col. 28 lines 21-26). Naughton further teaches the method where the conditioned media is formulated in a liposome (nano-container) to extend the life time of the active factors (Col. 22 lines 10-13). In further support, Srivastava teaches liposome-encapsulated drugs with selective targeting moieties attached to the outer surface of the liposomes (0004 and 0014). Srivastava teaches that targeting protects key organs against toxicity from the drugs (0004). In addition, Srivastava teaches that the targeting moiety can be an antibody or a polypeptide (0004).
Accordingly, one of ordinary skill in the art would have been motivated to modify the method of U.S. Patent No. 8,535,913 so that the CCM is formulated in a liposome with targeting moieties for the benefit of extending the life time of the active factors of the CCM, to have specific tissue delivery to avoid any off target side effects, and to deliver the CCM to the intended tissue as taught by Naughton and Srivastava. It would have been obvious to one of ordinary skill in the art to make such a modification to U.S. Patent No. 8,535,913, since Naughton teaches encapsulating CCM in liposomes (nano-container) for tissue delivery and Srivastava teaches liposomes with targeting moieties including antibodies and polypeptides for tissue specific delivery. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to U.S. Patent No. 8,535,913, since CCM was known to be encapsulated in nano-containers as taught by Naughton and liposomes were known to have targeting moieties for specific tissues such as antibodies and polypeptides as taught by Srivastava.
Claims 1-8 and 9 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 5-8 of U.S. Patent No. 8,530,415. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the issue patent. In addition, both claim methods of administering a cell cultured conditioned medium (CCM) to a subject.
With respect to instant claim 1, claims 5-8 of U.S. Patent No. 8,530,415 recite a method of administering a cell culture conditioned medium (CCM) composition to cells to be repaired and/or regenerated. It is noted the claims of U.S. Patent No. 8,530,415 do not recite that the method can be used in the manner instantly claimed for promoting autophagy and/or proteasome activation as recited in claim 1. Although the claims do not recited administering the CCM composition to a subject, it would have been obvious to one of ordinary skill in the art based on claims 1-4 of U.S. Patent No. 8,530,415 which are directed to tissue regeneration patches that the cells being treated are in a subject. However, the claims of U.S. Patent No. 8,530,415 recite the claimed method of administering or a least suggest the administering a CCM composition to a subject. Once administered to the subject the cells would treat whatever conditions are present. Thus, the claimed result of promoting autophagy and/or proteasome activation must be inherent to the method as taught by the references and a necessary effect of practicing the method.
Claims 5-8 of U.S. Patent No. 8,530,415 recites the limitations of instant claim 2, where the CCM is produced by culturing cells in a suitable growth medium and where the cells produce and secrete a CCM. Claims 5-8 of U.S. Patent No. 8,530,415 recites the limitations of instant claims 3 and 4, where the cells are cultured under hypoxic conditions of 1-5% oxygen. Claims 5-8 of U.S. Patent No. 8,530,415 recites the limitations of instant claim 5, where the cells are fibroblast cells. Claims 5-8 of U.S. Patent No. 8,530,415 recites the limitations of instant claims 6 and 7, where the cells are cultured in a three dimensional condition on microcarrier beads.
Although the claims of U.S. Patent No. 8,530,415 do not recite that the method results in expression of ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof as recited in instant claim 9, this wherein clause recites an intended result of the method rather than requiring an additional step be performed. MPEP 2111.04 states “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” and that a such a clause ‘"in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Therefore since the claim only recite the results of the steps, then claims reading on the method of claim 1 will also read on these results since performing the same steps will inherently lead to the same results in the absence of evidence to the contrary including unexpected results. Since, the claims of U.S. Patent No. 8,530,415 recites the same step and method of claim 1, the result of increasing the expression of the proteins, ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof, should be inherent to practicing the method of U.S. Patent No. 8,530,415.
Claims 8 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-8 of U.S. Patent No. 8,530,415 in view of Naughton et al. (U.S. 8,535,913 B2) (ref. of record). As stated in the nonstatutory double patenting rejection above, although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the copending patent application. In addition, both claim methods of administering a cell cultured conditioned medium (CCM) to a subject. With respect to instant claim 1, claims 5-8 of Appl. No. 8,530,415 recite a method of administering a cell culture conditioned medium (CCM) composition to a subject.
The claims of Appl. No. 8,530,415 do not teach instant claim 8, where the CCM is administered topically, orally or intravenously. Similarly, The claims of Appl. No. 8,530,415 do not teach instant claim 18, where the CCM is administered by topical, oral, nasal, alveolar lavage, inhalation, intravenous or intracranial administration.
However, Naughton teaches a method of administering a cell culture conditioned medium (CCM) composition to a subject (abstract, Col. 22 lines 10-13, Col. 28 lines 21-26). Naughton teaches the method where the CCM is administered topically and intravenously (Col. 23 lines 6-30 and claim 13). Accordingly, it would have been obvious to one of ordinary skill in the art use known methods of administering a CCM to a subject in a method of treating with CCM such as topically and intravenously as taught by Naughton. Such a modification to the method recited in the claims of Appl. No. 8,530,415 would have had a reasonable expectation of success, since CCM was known to be administered by these mechanisms for treatment purposes.
Claims 19 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-8 of U.S. Patent No. 8,530,415 in view of Naughton et al. (U.S. 8,535,913 B2) (ref. of record) and Srivastava et al. (US 2006/0210549 A1). As stated in the nonstatutory double patenting rejection above, although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the copending patent application. In addition, both claim methods of administering a cell cultured conditioned medium (CCM) to a subject. With respect to instant claim 1, claims 5-8 of U.S. Patent No. 8,530,415 recite a method of administering a cell culture conditioned medium (CCM) composition to a subject.
The claims of U.S. Patent No. 8,530,415 do not teach instant claim 19, where the CCM composition is administered in a nano- container conjugated to a targeting moiety for specific tissue delivery. The claims of U.S. Patent No. 8,530,415 do not teach instant claim 20, where the targeting moiety for specific tissue delivery is an aptamer, antibody, antibody fragment, peptide or affinity ligand that recognizes a tissue specific surface or internalization biomarker.
However, Naughton teaches a method of administering a cell culture conditioned medium (CCM) composition to a subject (abstract, Col. 22 lines 10-13, Col. 28 lines 21-26). Naughton further teaches the method where the conditioned media is formulated in a liposome (nano-container) to extend the life time of the active factors (Col. 22 lines 10-13). In further support, Srivastava teaches liposome-encapsulated drugs with selective targeting moieties attached to the outer surface of the liposomes (0004 and 0014). Srivastava teaches that targeting protects key organs against toxicity from the drugs (0004). In addition, Srivastava teaches that the targeting moiety can be an antibody or a polypeptide (0004).
Accordingly, one of ordinary skill in the art would have been motivated to modify the method of U.S. Patent No. 8,530,415 so that the CCM is formulated in a liposome with targeting moieties for the benefit of extending the life time of the active factors of the CCM, to have specific tissue delivery to avoid any off target side effects, and to deliver the CCM to the intended tissue as taught by Naughton and Srivastava. It would have been obvious to one of ordinary skill in the art to make such a modification to U.S. Patent No. 8,530,415, since Naughton teaches encapsulating CCM in liposomes (nano-container) for tissue delivery and Srivastava teaches liposomes with targeting moieties including antibodies and polypeptides for tissue specific delivery. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to U.S. Patent No. 8,530,415, since CCM was known to be encapsulated in nano-containers as taught by Naughton and liposomes were known to have targeting moieties for specific tissues such as antibodies and polypeptides as taught by Srivastava.
Conclusion
No claims are allowed.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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