DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-4, 7, 11, 16, 26-33, 36-40 are pending and are under examination.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 7, 11, 16, 26-33, 36-40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is unclear and indefinite, since it recites several optional limitations separated by an “or” or “and/or”. For example, is the claim directed to an engineered immune cell “or” optionally a cytokine. Likewise, the last limitation of the claim recites “and/or” TCF-1. Does the claim intend to encompass TCF-1, or is this claim intending that TCF-1 is an optional cytokine? It is noted that TCF-1 is a transcription factor and not a cytokine, and the scope of the optional limitations and the scope of TCF-1 as it relates to the engineered immune cells is unclear and indefinite. Furthermore, regarding the other optional limitation for the nucleic acid sequence, it appears SEQ ID NO: 7 encodes SEQ ID NO: 2, while SEQ ID Nos 8-9 encode SEQ ID NO: 1. However, the optional limitations appear to encompass selecting SEQ ID NO: 1, optionally wherein the nucleic acid could be SEQ ID NO: 7, which renders the scope of the claims unclear. Here, the claims recite a broad recitation (i.e. any nucleic acid encoding SEQ ID NO: 1 and 2 or a cytokine) and an optional narrow limitation, (i.e. nucleic acid that is any one of SEQ ID NO: 7-9 or TNFa). Use of a narrow numerical range that falls within a broader range in the same claim may render the claim indefinite when the boundaries of the claim are not discernible. Description of examples and preferences is properly set forth in the specification rather than in a single claim. A narrower range or preferred embodiment may also be set forth in another independent claim or in a dependent claim. If stated in a single claim, examples and preferences lead to confusion over the intended scope of the claim. Similar issues exist regarding the optional limitations of claims 4, 7, 11, 26, and 32. Additionally, in, for example claim 7, so many nested optional limitations are recited, that the scope of the claim becomes unclear and indefinite.
Claim 26 is unclear and indefinite since it is directed to a method of treatment in a subject in need thereof and comprises the step of administering an engineered immune cell to “a recipient subject”. It is not clear if the recipient subject to which the cell is administered is he same as the subject in need of treatment recited in the preamble. For example, would the claim encompass administering the engineered immune cell to a recipient subject that is different from the subject in need thereof? How would this treat the subject in need thereof? It is suggested to amend the preamble to recite “a recipient subject in need thereof”, wherein the engineered immune cell is administered to “the recipient subject”, for example.
Regarding claim 30, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 39 is unclear and indefinite since it recites two wherein clauses, but no “and” or “or” separates them . Therefore, it is not clear if the claim requires both wherein clauses to be satisfied, or whether the claim would encompass only one of the conditions. For the purpose of examination, the claim is being treated as encompassing wherein the T cells are CD8+ cytotoxic T cells, CD4+ T cells, or wherein the T cells comprise a native TCR, a non-native TCR, or a CAR.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 32-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (product of nature) without significantly more. The claim(s) recite(s) an expression vector including a nucleic acid sequence encoding GLUT5 of SEQ ID NO: 1 and fructose. This judicial exception is not integrated into a practical application because said nucleic acids and fructose are products of nature. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
Laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature. The courts have often described these exceptions using other terms, including “physical phenomena,” “scientific principles”, “natural laws,” and “products of nature.” Product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g.,Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 (“Contrary to Myriad's argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible.”). Thus, a synthetic, artificial, or non-naturally occurring product such as a cloned organism or a human-made hybrid plant is not automatically eligible because it was created by human ingenuity or intervention. See, e.g.,In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (cloned sheep); cf. J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 130-132, 60 USPQ2d 1868-69 (2001) (hybrid plant). Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart. See MPEP 2106.04(b).
In the instant case, the claims are directed to compositions of matter as set forth in Step 1 of the subject matter eligibility test (see MPEP 2106). Regarding step2A, prong 1, the claims recite an expression vector that includes a nucleic acid sequence encoding GLUT5. The instant specification discloses that as used herein “expression vector” includes vectors capable of expressing DNA that is operatively linked with regulatory sequences, such as promoter regions, that are capable of effecting expression of such DNA. Thus, the broadest reasonable interpretation of the claimed expression vector would encompass the naturally occurring GLUT5 gene, which includes a nucleic acid sequence encoding GLUT5 linked with regulatory sequences, such as promoters. Furthermore, fructose is also a naturally occurring sugar that is found together in the blood with cells expressing GLUT5. For example, blood comprises fructose and also comprises erythrocytes which comprise GLUT5 gene, i.e. an expression vector encoding GLUT5 (See Concha, 1997, Liang, 2021, of record, and GenBank Accession AAA52570.1, 199).
Regarding step 2A prong two and step 2B, the claims do not recite additional elements that integrate the judicial exception into a practical application, nor do the claims recite any additional elements that amount to significantly more than the judicial exception. The only other limitations recited is a “kit” and instructions. Regarding the instructions, to be given patentable weight, any printed matter and associated product must be in a functional relationship in order to be given patentable weight. See MPEP 2111.05, where the printed matter and the product do not depend on each other, no functional relations exists. For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864. Moreover, the limitations of a kit and instructions, recited at a high level of generality amount to nothing more than field of use or insignificant extra-solution activity. Regarding claim 33, erythrocytes would also comprise natural genes (i.e. vectors) encoding various cell surface proteins that bind to their natural ligand, i.e. target antigens.
Amendment to recite that the expression vector comprises a heterologous nucleic acid sequence, for example, would be remedial.
It is noted that claim 1 is not rejected, since the claim is directed to an engineered immune cell comprising a “non-endogenous” expression vector, which would not read on the naturally occurring GLUT5 gene of an immune cell, since this would be “endogenous” with respect to the immune cells, and therefore would not be within the scope of the claimed non-endogenous expression vector.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 26-31, 36-40 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:
A method for treating cancer or inhibiting tumor growth or metastasis in a recipient subject in need thereof comprising administering to the recipient subject an effective amount of an engineered immune cell comprising a non-endogenous expression vector that includes a nucleic acid sequence encoding a GLUT5 amino acid sequence of SEQ ID NO: 1 or SEQ ID NO: 2;
does not reasonably provide enablement for:
a method for restoring T cell functionality under limiting glucose conditions in vivo in a subject in need thereof comprising administering to the subject an effective amount of an engineered immune cell comprising a non-endogenous expression vector that includes a nucleic acid sequence encoding a GLUT5 amino acid sequence of SEQ ID NO: 1 or SEQ ID NO: 2;
The specification disclosure is insufficient to enable one skilled in the art to practice the invention as claimed without an undue amount of experimentation. Undue experimentation must be considered in light of factors including: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill in the art, the level of predictability of the art, the amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention, in re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
“The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.” In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling (MPEP 2164.03)” The MPEP further states that physiological activity can be considered inherently unpredictable.
The claims encompass a method of restoring T cell functionality under limiting glucose conditions in vivo in a subject in need thereof comprising administering to the subject an engineered immune cell comprising a non-endogenous expression vector that includes a nucleic acid sequence encoding a GLUT5 amino acid sequence of SEQ ID NO: 1 or SEQ ID NO: 2. The claims encompass a large genus of different immune cells, including macrophages, B cells, or dendritic cells. The claims also encompass a large genus of different glucose limiting conditions. For example, glucose can be limited in various pathological conditions where glucose metabolism is increased, such as the joints during rheumatoid arthritis, wherein synovial fibroblasts show increased glucose metabolism (see Mauko, 2022). Thus, the present claims would encompass autoimmune disease as the conditions of limiting glucose metabolism. However, restoring T cell functionality in the context of autoimmune disease would be detrimental and highly unpredictable, since functional T cells can exacerbate autoimmunity. Likewise, the claims encompass using any immune cell to restore “T cell functionality”. For example, the present claims would encompass administering a GLUT5 engineered macrophage to restore T cell functionality under glucose limiting conditions. The specification discloses that it is the engineered cell itself that exhibits restored functionality owing to the expression of GLUT5. For example, a T cell engineered to express GLUT5 exhibits restored T cell functionality, however, it would be highly unpredictable to restore T cell functionality under limiting glucose by administering a GLUT5 expressing macrophage, for example, as encompassed by the present claims.
Thus, given the breadth of the claims and the unpredictability of the art, the instant specification must provide a sufficient and enabling disclosure commensurate in scope with the instant claims. The only guidance regarding conditions of limiting glucose are those present in cancer/tumor microenvironment. No guidance is provided for practicing the claimed invention in any other glucose limiting conditions. Regarding restoring T cell functionality, the specification discloses an example where a macrophage engineered to express GLUT5 can treat cancer owing to an increased functionality of the macrophage to phagocytosis tumor cells. However, no examples or guidance are provided for restoring T cell functionality under glucose limiting conditions with a macrophage. The only examples or guidance for restoring T cell functionality is by using a T cell engineered to express GLUT5. Thus, given the breadth of the claims, the unpredictability of the art, and the lack of guidance provided by the instant specification, it would require undue experimentation to practice the full scope of the claimed method.
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.
Claim(s) 1-4, 7, 11, 16, 26-33, 36-40 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by WO2020/0010110, as evidenced by GenBank Accession AAA52570.1, 1994.
WO2020/010110 teaches genetically modified immune cells, such as T cells or NK cells, that overly express a GLUT polypeptide, and further express a CAR (see pages 2-3, in particular). WO2020/010110 teaches that the cells are genetically modified by an expression vector, such as a viral vector, comprising a nucleic acid and an expression control sequence encoding said GLUT polypeptide and CAR (i.e. a non-endogenous expression vector, see page 6, in particular). WO2020/010110 teaches that the CAR comprises an extracellular antigen binding domain that binds a tumor antigen, a transmembrane domain, and an intracellular domain (See page 3, in particular). WO2020/010110 teaches that the immune cells are autologous and allogeneic and can be administered as a pharmaceutical formulation to a human patient suffering from cancer for cancer treatment (See page 7, in particular). WO2020/010110 teaches that the engineered immune cells are obtained by isolating immune cells from a donor subject and transducing the immune cells with the vector, wherein the donor can be allogenic or autologous with respect to the subject that the cells are administered to (see pages 7, 63-67, and 80, in particular). WO2020/010110 teaches intravenous administration, further sequential administration of chemotherapeutic agents or anti-cancer agents, and treating lymphoma (see page 76 and 87, in particular). WO2020/010110 teaches kits comprising said genetically engineered immune cells (i.e. comprising said nucleic acid) and further comprising an ant-cancer agent and instructions for use (see pages 89-91, in particular). WO2020/010110 teaches that the GLUT polypeptide may be any of class I, II or III glucose transports, including GLUT5, and that the GLUT may be human (see page 12, in particular). In other words, the reference teaches human GLUT5, which inherently has the sequence of SEQ ID NO: 1 (as evidenced by GenBank Accession AAA52570.1).
Regarding the limitation that the cells lack expression of a cytokine, it is noted that each immune cell type expresses certain cytokine types, but not every cytokine. For example, NK cells or T cells would not produce macrophage or dendritic cells specific cytokines,. Therefore, the immune cells, such as T cells or NK cells, of the prior art would inherently lack expression of at least some types of cytokines, thus meeting the claim limitation.
Regarding claim 31, fructose is commonly ingested as part of the normal diet, as it is found in a variety of fruits and vegetables. Therefore, said subjects would inherently be administered fructose as part of a normal diet sequentially with said immune cells (see paragraph 34 of the instant specification wherein administration includes oral administration, i.e. ingestion).
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.
Claims 1-4, 7, 11, 16, 26-33, 36-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2020/0010110, in view of GenBank Accession AAA52570.1, 1994 and Kang, 2000..
The teachings of WO2020/010110 are described above. It is noted that even though the limitation of SEQ ID NO: 1 is inherent in the prior art reference for the reasons set forth above, it would also be obvious that human GLUT5 would have the sequence of SEQ ID NO: 1, as taught by GenBank Accession AAA52570.1. Likewise, even though the limitation of lacking expression of a cytokine is inherent for the reasons set forth above, it would also be obvious to further engineer the CAR T cells to lack expression of a cytokine such as IL-6 based on the teachings of Kang.
Kang teaches that CAR T cells can be engineered to knockdown or knockout expression of IL-6 (i.e. to lack expression of IL-6) and that doing so improves safety.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, to further engineer the CAR T cells of WO2020/0010110, to lack expression of IL-6, as taught by Kang. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, to improve safety.
Additionally, regarding claim 31, it would also be obvious that the treated patients would be sequentially orally administered fructose as part of their normal diet.
Claim(s) 1-4, 7, 11, 16, 26-27, 31, 36-40 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by 20210115453 (of record).
The ‘543 publication teaches modified immune cells that express a human therapeutic glucose/fructose transporter SLC2A5 (i.e. GLUT5) protein of SEQ ID NO: 12364, which is 100% identical to SEQ ID NO: 1 of the instant application, (see paragraphs 100, 411 and Table 1, in particular). The ‘543 publication teaches that the therapeutic protein is expressed from a transposon delivery vector and includes a promoter (i.e. a non-endogenous vector, see paragraph 40, 422, in particular). The ‘543 publication teaches using a plasmid vector (see examples). The ‘543 publication teaches autologous or allogeneic immune cells, or that the immune cell is a T cell or NK cell (i.e. cells comprising a native TCR, see paragraphs 13-17, 101, in particular). The ‘543 publication teaches using the immune cells therapeutically by systemic administration in a human subject in need thereof, i.e. as pharmaceutical composition, and this would inherently restore T cell functionality (see paragraph 411, in particular). Regarding claim 7, T cells or immune cells inherently comprise receptors that bind to a target antigen. For example, T cells comprise a TCR. Other immune cells also comprise numerous receptors that bind to various ligands (i.e. “target antigens”). It is noted that claim 11 is included in the rejection to the extent that it defines features of the CAR, which are optional, i.e. claim 11 does not require a CAR. Likewise, claim 27 is included to the extent that it defines the type of cancer, but does not require treating cancer. For example, incorporating claim 27 into claim 26 would be a method of treating cancer or restoring T cell functionality, wherein the cancer is adrenal cancer, i.e. it would encompass restoring T cell functionality. Claim 40 is included for the same reasons.
Regarding the limitation that the cells lack expression of a cytokine, it is noted that each immune cell type expresses certain cytokine types, but not every cytokine. For example, NK cells or T cells would not produce macrophage or dendritic cells specific cytokines,. Therefore, the immune cells or T cells of the prior art would inherently lack expression of at least some types of cytokines, thus meeting the claim limitation.
Regarding claim 31, fructose is commonly ingested as part of the normal diet, as it is found in a variety of fruits and vegetables. Therefore, said subjects would inherently be administered fructose as part of a normal diet sequentially with said immune cells (see paragraph 34 of the instant specification wherein administration includes oral administration, i.e. ingestion).
Claims 1-4, 7, 11, 16, 26-33, 36-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over 20210115453, in view of US 2023/0248824, Chen et al., 2016, and Kang, 2000..
The teachings of the ‘453 publication are described above.
The reference differs from the claimed invention in that it does not explicitly teach that the T cells expressing GLUT5 comprise a CAR, or the use of the GLUT5 T cells for treating cancer.
The ‘824 publication teaches that nucleic acids encoding glucose transporters can be incorporated into expression vectors for modifying T cells to modulate the growth rate and increase cytolytic flux in the resulting T cells (see paragraphs 8-9, in particular). The ‘824 publication teaches that the T cells can be further modified with a nucleic acid encoding a CAR (see paragraph 11, in particular). The ‘824 publication teaches that the T cells can be used to treat cancer (See paragraph 16, in particular). The ‘824 publication explains that engineering CAR T cells with a glucose transporter allows for enhanced metabolic reprogramming to overcome nutrient depleted microenvironment present in cancer, including leukemia (See paragraph 58, 64, and 122, in particular). The ‘824 publication teaches intravenous administration and administration of additional anti-cancer agents (see paragraph 63 and entire document).
Chen teaches that in acute leukemia, the microenvironment is characterized by an abundance of fructose, while being glucose insufficient, and that GLUT5 can enhance fructose utilization to allow for cell growth under low glucose conditions.
Kang teaches that CAR T cells can be engineered to knockdown or knockout expression of IL-6 (i.e. to lack expression of IL-6) and that doing so improves safety.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, to administer the GLUT5 T cells of the ‘453 publication, for treating cancer with a co-expressed CAR, as taught by the ‘824 publication and Chen. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because the ’824 publication teaches glucose/fructose transporter GLUT5 expressing T cells, and the ‘824 publication teaches that glucose transporter modified T cells are useful for co-expression of a CAR to target tumor antigens and treat cancer, since they glucose transporter allows for enhanced metabolic reprogramming to overcome nutrient depleted microenvironment present in cancer, including leukemia. Furthermore, the ordinary artisan would be particularly motived to use the GLUT5 expressing T cells for treating acute leukemia, since Chen teaches that the leukemia microenvironment is characterized by an abundance of fructose, and the references teach that GLUT5 enables glucose or fructose uptake for cell growth. Furthermore, it would be further obvious to administer a second anti-cancer therapy to improve treatment outcomes.
Furthermore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, to further engineer the CAR T cells made obvious by the ‘824 publication and ‘453 publication, to lack expression of IL-6, as taught by Kang. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, to improve safety.
Additionally, regarding claim 31, it would also be obvious that the treated patients would be sequentially orally administered fructose as part of their normal diet.
It would also be obvious to store the reagents in the form a kit for treating cancer as a matter of convenience. Additionally, as Chen teaches assays for evaluating fructose uptake in GLUT5 expressing cells, it would also be obvious to store the GLUT-5 CAR T cells made obvious above and fructose together in the form of a kit as a matter of convenience in order to perform assays to ascertain fructose uptake. Regarding the instructions and to the extent that his requires printed material, the printed matter and associated product must be in a functional relationship in order to be given patentable weight. See MPEP 2111.05, where the printed matter and the product do not depend on each other, no functional relations exists. For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864.
Claim 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liang, March 2021 (of record), in view of GenBank Accession AAA52570.1, 1994.
Liang teaches an expression vector that includes a nucleic acid sequence encoding GLUT5 for expression in human cells, wherein the cells can be grown in fructose containing medium. Although not specifically disclosed, it would be obvious, as a matter of convenience to store the reagents necessary for generating and growing the cells of Liang (i.e. the vector and the fructose) in the form of a kit for transduction/cell growth as a matter of convenience. Although Liang does not explicitly teach that the GLUT5 has SEQ ID NO: 1, it would be obvious to use the human GLUT5 sequence for expression in human cells, and selecting the known human GLUT5 sequence of GenBank Accession AAA52570.1, would be well within the purview of the ordinary artisan.
Regarding the instructions and to the extent that his requires printed material, the printed matter and associated product must be in a functional relationship in order to be given patentable weight. See MPEP 2111.05, where the printed matter and the product do not depend on each other, no functional relations exists. For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644
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