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.
Response to Amendments
Applicant’s amendments and response filed Jul. 6, 2026 have been received and entered into the case.
Status of the Claims
Claims 1-7, 10-17, 19 and 20 are currently pending.
Claims 1-2, 6 and 19 are amended.
Claims 10-17 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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 8-9 and 18 are cancelled.
Claims 1-7, 19 and 20 have been considered on the merits.
Claim Objections
The claim objections are withdrawn due to amendment.
Claim Rejections - 35 USC § 112(a)
The claim rejections under 35 USC § 112, (a) or first paragraph (pre-AIA ), are withdrawn due to amendment.
Claim Rejections - 35 USC § 112
The claim rejections under 35 USC § 112, (d) or fourth paragraph (pre-AIA ), are withdrawn due to amendment.
Claim Rejections - 35 USC § 102
The claim rejections under 35 USC § 102 are revised due to amendment. New claim rejections under 35 USC § 102 have been added to address the claim amendments.
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 1-7 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). Kellar teaches the method where the CCM is administered topically (pg. 191 Col. 2 para. 2 and 4).
With respect to the limitation of the subject being in need of increased autophagy and/or proteasome activation as recited in claim 1, Kellar teaches the subject is need of skin repair (abstract). Since autophagy and proteasome activation is part the body’s process of clearing out damaged cell parts and proteins the subject is need of autophagy and proteasome activation.
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.
Although Kellar does not teach that the method results in expression of ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof as recited in instant claim 1, this 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 limitation 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.
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).
Therefore, the reference anticipates the claimed subject matter.
Claims 1-7 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). Naughton teaches the method where the CCM is administered to the skin surface (topically) (Col. 4 lines 33-41) teaches the method where the CCM is administered topically (Col. 23 lines 6-30 and claim 13).
With respect to the limitation of the subject being in need of increased autophagy and/or proteasome activation as recited in claim 1, Naughton teaches the subject is need of skin repair (Col. lines 40-59). Since autophagy and proteasome activation is part the body’s process of clearing out damaged cell parts and proteins the subject is need of autophagy and proteasome activation.
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.
Although Naughton does not teach that the method results in expression of ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof as recited in instant claim 1, this 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 limitation 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 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).
Therefore, the reference anticipates the claimed subject matter.
Claim Rejections - 35 USC § 103
The claim rejections under 35 USC § 103 are withdrawn due to amendment. New claim rejections under 35 USC § 103 have been added to address the claim amendments.
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 1-7 and 19-20 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) (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). Kellar teaches the method where the CCM is administered topically (pg. 191 Col. 2 para. 2 and 4).
With respect to the limitation of the subject being in need of increased autophagy and/or proteasome activation as recited in claim 1, Kellar teaches the subject is need of skin repair (abstract). Since autophagy and proteasome activation is part the body’s process of clearing out damaged cell parts and proteins the subject is need of autophagy and proteasome activation.
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.
Although Kellar does not teach that the method results in expression of ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof as recited in instant claim 1, this 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 limitation 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.
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).
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 lifetime 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 lifetime 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 1-7 and 19-20 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) (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). Naughton teaches the method where the CCM is administered to the skin surface (topically) (Col. 4 lines 33-41) teaches the method where the CCM is administered topically (Col. 23 lines 6-30 and claim 13).
With respect to the limitation of the subject being in need of increased autophagy and/or proteasome activation as recited in claim 1, Naughton teaches the subject is need of skin repair (Col. lines 40-59). Since autophagy and proteasome activation is part the body’s process of clearing out damaged cell parts and proteins the subject is need of autophagy and proteasome activation.
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.
Although Naughton does not teach that the method results in expression of ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof as recited in instant claim 1, this 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 limitation 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 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 claim 19, Naughton teaches the conditioned media is formulated in a liposome (nano-container) to extend the lifetime 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 obviousness-type double patent rejection over 19/359318 are been withdrawn since application has been abandoned.
The nonstatutory obviousness-type double patent rejection over Appl. No. 17/393356, U.S. Patent No. 8,535,913, and U.S. Patent No. 8,530,415 have been revised due to amendments.
Claims 1-7 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 2 and 21 of copending Application No. 17/393356 in view of Naughton et al. (U.S. 8,535,913 B2) (ref. of record).
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, 2 and 21 of Appl. No. 17/393356 recite a method of administering a cell culture conditioned medium (CCM) composition to a subject with atopic, allergic contact, irritant contact and seborrhoeic dermatitis. 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.
With respect to the limitation of the subject being in need of increased autophagy and/or proteasome activation as recited in claim 1, the claims of Appl. No. 17/393356 teach the subject is need of skin repair (claim 2). Since autophagy and proteasome activation is part the body’s process of clearing out damaged cell parts and proteins the subject is need of autophagy and proteasome activation.
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 1, 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.
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.
The claims of Appl. No. 17/393356 do not teach instant claim 1, where the CCM is administered topically.
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 (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, 2 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) (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 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 lifetime 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 lifetime 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 1-7 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. Claim 13 of U.S. Patent No. 8,535,913 recites the limitations of instant claim 1, where the CCM is administered topically.
With respect to the limitation of the subject being in need of increased autophagy and/or proteasome activation as recited in claim 1, claims of U.S. Patent No. 8,535,913 teaches the subject is need of hair growth (claims 11 and 12). Since autophagy and proteasome activation is part the body’s process of growing hair the subject is need of autophagy and proteasome activation.
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.
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 1, 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) (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 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 lifetime 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 lifetime 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 in view of Naughton et al. (U.S. 8,535,913 B2) (ref. of record). 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 recite 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.
With respect to the limitation of the subject being in need of increased autophagy and/or proteasome activation as recited in claim 1, the claims of U.S. Patent No. 8,530,415 teach the subject is need of repair (claim 5). Since autophagy and proteasome activation is part the body’s process of clearing out damaged cell parts and proteins the subject is need of autophagy and proteasome activation.
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 1, 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 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.
The claims of Appl. No. 8,530,415 do not teach the method where the CCM is administered topically as recited in instant claim 1.
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 (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 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) (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 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 lifetime 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 lifetime 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.
Response to Arguments
Applicant's arguments filed Jul. 6, 2026 have been fully considered but they are not persuasive.
With respect to the rejections under 35 U.S.C. § 102 as being anticipated by Kellar, Applicant argues that Kellar does not teach or suggest a method to increase the self-destruction of skin cells and/or proteins by increasing the ATG5, ATG7, ATG12, BECN1, MAPILC3, POMP, PSMB5, PSMB6 or a combination thereof and only teach using topically applied CCM composition to reduce erythema, edema and flaking skin caused by laser treatments (Remarks pg. 7 para. 2).
However, these arguments fail to persuade because the Kellar teaches the claimed method of administering a CCM composition to a subject. Thus, the claimed results (promoting autophagy and/or proteasome activation and the expression of ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof) must be inherent to the method taught by Kellar. It is maintained that these limitations only recite the results of the steps, then art reading on claimed steps 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. Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) provides "that since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims." In the instant case, the claims are drawn to an invention employing the same treatment steps but the outcome is alleged to be different. Applicant is required to recite the missing steps to form the alleged different outcome in view of the above-cited decision.
With respect to the rejections under 35 U.S.C. § 102 as being anticipated by Naughton, Applicant argues that Naughton does not teach or suggest a CCM composition contains proteins such as ATG5, ATG7, ATG12, BECN1, MAPILC3, POMP, PSMB5, PSMB6 or a combination thereof and describes many potential uses for CCM and that CCM compositions contain growth factors and other proteins that increase the production of extra cellular matrix materials such as collagen (Remarks pg. 7 para. 5). Applicant argues that Naughton does not teach or suggest that the CCM compositions can be applied to a subject in need of increased autophagy and/or proteasome activation (Remarks pg. 7 last para.). Applicant argues that Naughton does not teach or suggest a method to increase the self-destruction of skin cells and/or proteins by increasing the ATG5, ATG7, ATG12, BECN1, MAPILC3, POMP, PSMB5, PSMB6 or a combination thereof (Remarks pg. 8 para. 2).
However, these arguments fail to persuade because the Naughton teaches the claimed method of administering a CCM composition to a subject. Thus, the claimed results (promoting autophagy and/or proteasome activation and the expression of ATG5, ATG7, ATG12, BECN1, MAP1LC3, POMP, PSMB5, PSMB6 or combination thereof) must be inherent to the method taught by Naughton. It is maintained that these limitations only recite the results of the steps, then art reading on claimed steps 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. Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) provides "that since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims." In the instant case, the claims are drawn to an invention employing the same treatment steps but the outcome is alleged to be different. Applicant is required to recite the missing steps to form the alleged different outcome in view of the above-cited decision.
With respect to the rejections under 35 U.S.C. § 103, Applicant argues that Kellar and Naughton and Naughton do not teach a method to increase the self-destruction of skin cells and/or proteins by increasing the ATG5, ATG7, ATG12, BECN1, MAPILC3, POMP, PSMB5, PSMB6 or a combination thereof (Remarks pg. 8 last para. to pg. 9 para. 2). Applicant argues that the addition of Naughton to Kellar would teach away from the claimed invention, since Naughton teaches that the CCM compositions of Kellar are useful in regenerating cells and tissues and does not mention that CCM composition promote the self-destruction of skin cells and/or proteins. Applicant further argues that one of ordinary skill in the art would not look to Naughton and Kellar if they are looking to increase the expression of the claimed genes to promote self-destruction (Remarks pg. 9 para. 3). These arguments were not found to be persuasive, for the same reasons the arguments with respect to the rejections under 35 U.S.C. § 103, were not found to be persuasive as stated above. Briefly, both Kellar and Naughton teach the claimed method, therefor these results should be inherent to practicing the methods taught by Kellar and Naughton.
Applicant argues that Srivastava doesn’t remedy the deficiencies of Kellar and Naughton, since Srivastava does not mention CCM (Remarks pg. 9 para. 4). However, this argument was not found to be persuasive, since the arguments with respect to the rejections over Kellar and Naughton were not found to be persuasive as explained above.
With respect to the nonstatutory obviousness-type double patent rejection over 17/393356, Applicant argues that the claims of the application alone or in combination with Naughton and Srivastava recite a method for reducing inflammation and not a method for topically applying a CCM composition to a subject in need of autophagy and/or proteasome activation and increasing the self-destruction of skin cells and/or proteins by increasing the ATG5, ATG7, ATG12, BECN1, MAPILC3, POMP, PSMB5, PSMB6 or a combination thereof (Remarks pg. 10 para. 4). However, this argument was not found to be persuasive, since when the claims of Appl. No. 17/393356 are taken with Naughton, the claimed method is taught. Therefore, the claimed results should be inherent to practicing the method taught by the combined teaching of the claims of Appl. No. 17/393356 and Naughton.
Applicant argues that claims 11-13 of Naughton (this is being interpreted as a typo, and meant to refer to the claims of U.S. Patent No. 8,535,913) recite a method for promoting hair growth (Remarks pg. 11 para. 1). However, this argument was not found to be persuasive, since the claims of U.S. Patent No. 8,535,913 teaches the claimed method of administering a CCM composition topically. Therefore, the claimed results should be inherent to practicing the method taught by the claims of U.S. Patent No. 8,535,913.
With respect to the nonstatutory obviousness-type double patent rejection over US Pat. 8,530,415, Applicant argues that the claims of the patent alone or in combination with Naughton and Srivastava recite a method for repairing or regenerating cells and not a method for topically applying a CCM composition to a subject in need of autophagy and/or proteasome activation and increasing the self-destruction of skin cells and/or proteins by increasing the ATG5, ATG7, ATG12, BECN1, MAPILC3, POMP, PSMB5, PSMB6 or a combination thereof (Remarks pg. 11 para. 2). However, this argument was not found to be persuasive, since when the claims of US Pat. 8,530,415 are taken with Naughton, the claimed method is taught. Therefore, the claimed results should be inherent to practicing the method taught by the combined teaching of the claims of US Pat. 8,530,415 and Naughton.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632
