DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment filed 26 December 2025 is acknowledged and has been entered.
Status of the Claims
Claims 1-18, 24, 25 and 28-30 have been cancelled.
Claim 23 is withdrawn.
Claims 19-22, 26-27 and 31-34 are presented for examination on the merits.
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 19-22, 26-27 and 31-34 stand 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 treatment of specific cancer types in vitro (e.g., human osteosarcoma, melanoma and glioblastoma cell lines), with specific preparations (i.e., NVD002 and NVD003), does not reasonably provide enablement for treatment of bone cancer, brain cancer and skin cancer, with any composition comprises:(i) an extracellular extract comprising exosomes and (ii) and excipient.
According, it would take undue experimentation without a reasonable expectation of success for one of art the art to provide a pharmaceutical composition with exosomes having the recited functional effect of preventing cancer, as instantly claimed.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Undue experimentation would be required to practice the invention as claimed due to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples provided in the specification; nature of the invention; state of the prior art; relative skill level of those in the art; predictability or unpredictability in the art; and breadth of the claims. In re Wands, 8USPQ2d 1400, 1404 (Fed. Cir. 1988).
Applicant’s claims are drawn to a method of treating cancer with an exosomal fraction from mature cells. However, the specification provides only the working examples of NVD002 and NVD003, prepared according to a specific method as described in Example 1 of the Specification.
An extraction product such as an exosome would possess varying pharmacological properties based upon their respective methods of extraction, such as specific conditions of extraction as well as cell type. Thus, the functional property of an exosomal extract is not considered to be predictable because the type of extraction used to produce the extract would have a significant impact on the chemical characteristics of the extract.
The specification does not provide any specific guidance to show that any and all exosomal extracts have the claimed cancer treating functionality. The specification only provides testing data that the extract produced by the extraction procedures and variables disclosed in Example 1. Given the wide range of possible resulting extracts that could potentially result from various extraction methods, the presence of a single example of an extract that possesses anti-cancer properties in an in vitro model provides insufficient guidance to the person to practice the invention.
In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970), held that "Inventor should be allowed to dominate future patentable inventions of others where those inventions were based in some way on his teachings, since such improvements while unobvious from his teachings, are still within his contribution, since improvement was made possible by his work; however, he must not be permitted to achieve this dominance by claims which are insufficiently supported and, hence, not in compliance with first paragraph of 35 U.S.C. 112; that paragraph requires that scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; in cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific law; in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved."
See Genentech v. Novo Nordisk, 108 F. 3d 1361, 1366 “Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 86 S. Ct. 1033, 1042-43, 16 L. Ed. 2d 69, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.”
Consequently, given the unpredictability of the art, the lack of guidance from the specification and the quantity of experimentation needed to practice the claimed invention, the claims are not considered to be enabled for the entire scope of the invention.
Claims 19-22, and 24-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the invention had possession, as of the filing date of the application, of the specific subject matter later claimed by him or her. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention.’ Lockwood v. American Airlines, Inc., 107 F. 3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F. 2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, no that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F. 3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP indicates:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
What constitutes a “representative number” is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a “representative number” depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly.
In Ariad Pharm. Inc. v. Eli Lily & Co. 598 F ad 1336 (Fed. Cir. 2010) en banc}, the Federal Circuit noted the importance of an application's disclosure, stating, “the hallmark of written description is disclosure.” A disclosure adequately describes an invention when it “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. at 1354. “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbot Labs, 636 F.3d 1341, 1948 (Fed. Cir. 2011)
Satisfying the written description requirement “varies with the nature and scape of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F. 3d 1349, 1357 (Fed. Cir. 2005). The Federal Circuit explained what is required to meet the written description requirement in Ariad Pharm., Inc. v. Eli Lilly & Co:
This inquiry, as we have long held, is a question of fact. Ralston Purina, 772 F.2d at 575. Thus, we have recognized that determining whether a patent complies with the written description requirement will necessarily vary depending on the context. Capon v Eshhar, 418 F.3d 1349, 1357-58 (Fed. Cir. 2005). Specifically, the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Id. For generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue." Id. at 1359.
A written description of a genus in biotechnological arts “requires a precise definition, such as by structure, formula, [or] chemical name” of the claimed subject matter sufficient to distinguish it from other materials. Regents of the Univ. of Cal. v. Eli Lilly & Co., 199 F.3d 1559, 1568 (Fed. Cir. 1997). The Federal Circuit reflected on Eli Lilly in Ariad while explaining how to sufficiently describe a genus in biotechnological applications:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species fitting within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. at 1568 (quoting Fiers v. Revel 984 F.2d 1164, 1171 (Fed. Cir. 1993). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
A “representative number of species” must typify the entire claimed genus and account for variation between the species of the genus:
[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictably in the results obtained from species other than those specifically enumerated. Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Or. 2004).
In Ariad, the Court also addressed the presence of a genus within a method claim, in Rochester, we held invalid claims directed to a method of selectively inhibiting the COX-2 enzyme by administering a non-steroidal compound that selectively inhibits the COX-2 enzyme. Id. at 918. We reasoned that because the specification did not describe any specific compound capable of performing the claimed method and the skilled artisan would not be able to identify any such compound based on the specification’s function description, the specification did not provide an adequate written description of the claimed invention. Id. at 927-28. Ariad, at 1373.
Applicant has provided evidence of only two preparations (NVD002 and NVD003), prepared according to a specific method as described in Example 1 of the Specification.
The claimed method specifies that any mature cell cultured together with any particulate material will result in a cellular and/or extracellular extract, which can be used to treat cancer or inflammation This is considered highly unsupported and entirely speculative, because it is definitely unlikely that this will be the case.
The specification provides ONE example of a cell type grown together with a particulate material; namely osteogenic differentiated adipose tissue derived stem cells grown together with "Cultispher" particles. Thus, only this cell type grown with these particles can be considered sufficiently supported by the specification.
Thus the level of skill and knowledge in the art is such that a single example of a particular extract would not provide sufficient evidence that Applicant is in possession of the claimed invention.
Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116).
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 31-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 31 is rendered vague and indefinite by the phrase “[t]he method according to claim 19, wherein inflammation”. However, there is not antecedent basis in claim 19 for the term “inflammation”, as the amending claims are directed to treating cancer. Does this mean that the inflammation is secondary to the cancer and treatment of cancer and inflammation are the same?
Appropriate clarification is required.
All other cited claims depend directly or indirectly from rejected claims and are, therefore, also rejected under U.S.C. 112, second paragraph, for the reasons set forth above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 19-22, 26-27 and 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Dufrane et al. (WO2020/058511) or Alsberg et al. (US2018/0371416) and Yu et al. (2017) in view of Brodie et al. (US2019/0269739) or Huang et al. (2017).
Dufrane et al. beneficially discloses a 3D biomaterial comprising adipose stem cells (ASCs) and gelatin, wherein the gelatin is porcine gelatin, and is in form of particles. The particles have a mean diameter of 50-1000 μ m. The ASCs are differentiated into cells comprising or consisting of osteoblasts, chondrocytes, keratinocytes, myofibroblasts, endothelial cells or adipocytes. The use in treating a tissue defect with the biomaterial is disclosed.
Alsberg et al teach "a tissue construct comprising includes a self- assembled, scaffold-free, high density cell aggregate. The cell aggregate includes a plurality of cells and a plurality of biocompatible and biodegradable nanoparticles and/or microparticles that are incorporated within the cell aggregate" (Abstract).
Alsberg et al teach "the cell aggregate is a self-assembled cell sheet that comprises undifferentiated and/or substantially differentiated progenitor cells, a plurality of nanoparticles and/or microparticles, and a self-secreted extracellular matrix of the undifferentiated and/or substantially differentiated progenitor cells that can bind to or permit the adhesion of cells in the aggregate" ([0012], the population of cells can comprise a population of human adipose derived stem (page 2) and "cells" ([0075], page 7, right column).
Alsberg et al teach "the nanoparticles and/or microparticles can be formed from a biocompatible and biodegradable polymer. Examples of biocompatible, biodegradable polymers include natural polymers, such as gelatin, " ([0062], page 5). The population of cells can comprise a population of human adipose derived stem cells ([0075], page 7). Thus, Alsberg et al teaches the scaffold-free tissue construct comprising differentiated human adipose derived stem cells, a gelatin, and self-secreted extracellular matrix is a scaffold-free biomaterial due to the synthesis of the extracellular matrix by the ASCs that are embedded in the extracellular matrix.
Alsberg et al teach that the nanoparticles and/or microparticles can be formed from a biocompatible and biodegradable polymer. Examples of biocompatible, biodegradable polymers include natural polymers, such as gelatin. [0062], page 5.
Alsberg et al teach hydrated microspheres were roughly spherical with similar average diameters (60.9±50.1 µm, "low Gp"; 54.3±47.9 µm, "high Gp") ([0143], page 17).
Alsberg et al teach that these culture systems take advantage of the abundant cell-cell interactions that occur in 3D high density culture, without the potential interference of a biomaterial scaffold ([0004], page 1) and the bioactive agent can induce the formation of a cell sheet, graft, or structure " ([0011], page 1).
Alsberg et al teach that mesenchymal stem cells (MSCs) can differentiate into many cell types of the connective tissue lineage including chondrocytes under appropriate conditions ([0003], Page 1), and "the system of self-assembling, microsphere-incorporated MSC sheets reported here is versatile, and may ccommodate the formation of sheets containing other cells with chondrogenic potential including adipose derived stem cells or mature chondrocytes" ([0126], Page 14).
The cited references do not disclose that the gelatin is in the form of porcine gelatin particles.
Yu et al teach decellularized adipose tissue microcarriers as a dynamic culture platform for human adipose-derived stem/stromal cell expansion (Title), and Cultispher-S microcarriers compose of crosslinked porcine gelatin (Page 67, left column). Yu et al also teach the use of adipose-derived ECM (Page 78, left col., 3rd para.) and the use of complex tissue-specific ECM-derived microcarriers provides a promising approach for ASC expansion under dynamic conditions (Page 79, left col., 3ʳᵈ para.).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the rejected claims to combine the teachings of prior art to modify the method of Dufrane or Alsberg et al by using gelatin derived from porcine as taught by Yu et al as instantly claimed, with a reasonable expectation of success. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to do so because Yu et al stated that "the ability to produce large ASC populations from small patient biopsies would represent a clinical advantage for the translation of innovative autologous or allogeneic therapies from the 'benchtop to the bedside" (Page 66, right column) and "this study demonstrates the promising application of our novel DAT microcarriers as a 3-D dynamic cell expansion platform to obtain large populations of multipotent ASCs from small tissue samples. From a clinical
perspective, the natural composition and cell-supportive qualities of the DAT microcarriers may be favorable for their application as an injectable cell delivery vehicle for autologous or allogeneic cell-based therapics. The studies in the current paper confirmed that the ASCs expanded on the DAT microcarriers retained their multilineage differentiation capacity upon extraction and induction using conventional culturing methods." One of ordinary skill in the art would have had a reasonable expectation of success in doing so because both Yu et al were successful in generation of decellularized adipose tissue microcarriers as a dynamic culture platform for human adipose-derived stem/stromal cell expansion (title) and provide detail for producing such scaffold-free biomaterial and for transplantation of such scaffold- free biomaterial to tissues.
The cited references does not disclose the treatment of cancer.
However, treatment of cancer by use of mature cells such as adipose tissue-derived stem cells is well known. For example, Brodie et al. beneficially teaches mesenchymal stem cell populations, their secreted extracellular vesicles (e.g., exosomes) and other products and their uses for treating diseases (e.g., cancer) in a subject. It is also disclosed that extracellular vesicles are membrane-derived extracellular vesicles that can be divided into three main groups: exosomes, microextracellular vesicles and apoptotic bodies. Exosomes are small membrane extracellular vesicles of endocytic origin with a size of 50-100 nm. They can contain microRNAs (miRNA), long non-coding RNAs (lncRNA), mRNAs, DNA fragments, and proteins, which are shuttled from donor to recipient cells. Exosomes appear to play an important role in the exchange of information in the tumor microenvironment, as they have been shown to mediate transfer of oncogenic proteins between cancer cells. On the other hand, exosomes have also been shown to program the immune system to elicit an anti-tumor response. Exosomes are also natural carriers for miRNAs and other non-coding RNAs, and the direct membrane fusion with the target cell allows contents to be delivered directly into the cytosol. This makes exosomes an excellent delivery system for small molecules. There is provided a pharmaceutical composition for use in treating a disease or condition comprising a pharmaceutically acceptable adjuvant, excipient or carrier and at least one of: (a) an isolated and enriched population of CH-MSCs; (b) extracellular vesicles derived from the CH-MSC population; (c) conditioned media from the CH-MSC population; and (d) extracellular matrix secreted by the CH-MSC population.
Huang et al. disclose a therapeutic strategy adopting adipose-derived stem cells (ADSCs) capable of carrying nanotherapeutic payloads selectively toward brain tumors for thermo/chemotherapy. The ADSC-based approach combined with high frequency magnetic field exhibits a sound therapeutic performance with a 4-fold increase in therapeutic index on brain astrocytoma (ALTS1C1)-bearing mice (C57BL/6 J) as compared to the typical chemotherapy using a current first-line chemodrug, temozolomide. Immunohistochemical examination of brain tumor sections confirms the successful cellular transport and pronounced cytotoxic action of therapeutics against tumor cells in vivo. This work demonstrates the promise of ADSC-mediated chemo/thermal therapy against brain tumors
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the instant Application to employ the preparations of Durfrane or Alsberg containing ASC and cultisphers to treat cancer, based on the cited references as well and the numerous prior art references cited by Applicant in the specification. It is already described in the prior art that various cell types including adipose derived stem cells contain (and secrete) substances and vesicles, which inhibit cancer cell proliferation.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). In KSR, the Supreme Court indicated that the obviousness analysis should consider the “background knowledge possessed by a person having ordinary skill in the art.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Under KSR, information deemed within PHOSITA’s general knowledge is more powerful than that found buried in a prior art reference because we assume that PHOSITA would consider using their general knowledge in combination with the prior art — even absent any express motivation to do so. Under 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. Regardless of the tribunal, the inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on such artisan’s knowledge.
The adjustment of particular conventional working conditions (e.g., determining an appropriate effective dose and/or employing one or more commonly-employed means of exosomal extraction, employing common adjuvant/excipients, etc.) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Accordingly, the instant claims, in the range of proportions where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
Response to Arguments
Applicant's amendments/arguments filed 26 December 2025 have been fully considered but they are not persuasive.
With respect to the 35 USC 112(a) rejections, the sole independent claim, has been narrowed, but still remains very broad and not fully supported by the evidence provided by the specification, which as stated previously, provides only the working examples of NVD002 and NVD003, prepared according to a specific method as described in Example 1 of the Specification.
With respect to the 35 USC 103 rejection, Applicant asserts that as amended, refers to "the particulate material is gelatin”, which is not disclosed by the cited reference
Applicant further submits that the application of KSR Int'l Co v Teleflex, Inc., 550 U.S. 398 (2007) as applied to the facts as set forth in the Office Action relies on excessive, impermissible hindsight combinations of the prior art including but not limited to the generic "based on the cited reference as well as the number of prior art references cited by Applicant in the specification" as lacking in the specificity required for a prima facie rejection based on obviousness.
However, the person of ordinary skill in the art is not without a minimal level of creativity and in KSR, the Supreme Court indicated that the obviousness analysis should consider the “background knowledge possessed by a person having ordinary skill in the art.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Under KSR, information deemed within PHOSITA’s general knowledge is more powerful than that found buried in a prior art reference because we assume that PHOSITA would consider using their general knowledge in combination with the prior art — even absent any express motivation to do so. Under 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. Regardless of the tribunal, the inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on such artisan’s knowledge.
The Applicant use of gelatin particles would be well within the purview of the skilled practitioner as the commercially available microcarrier Cultispher G as used by Applicant according to the specification. Combining ASCs known to possess cancer treatment potential with such microcarriers would certainly occur to one of ordinary skill in the art.
Applicant further asserts that the examiner’s conclusion of obviousness is based on improper hindsight reasoning. However “[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant's disclosure, such as reconstruction is proper." In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). MPEP 2145.X.A.
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.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 5712720947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RUSSELL G FIEBIG/Examiner, Art Unit 1655