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 .
Applicant canceled claims 3, 5-9, 12-15, 17-27, 29-36, 38-40, 42-51, 53-73, 75-86, 88-95, 99-102, 104-114, 116-127, 129-130, 132-138, 140-173, 175-183 and 185-189. Claims 1-2, 4, 10-11, 16, 28, 37, 41, 52, 74, 87, 96-98, 103, 115, 128, 131, 139, 174 and 184 are currently pending and under examination.
Information Disclosure Statement
The Information Disclosure Statement filed April 08, 2025 has been considered.
Claim Objections
Claims 16, 74, 103 and 139 are objected to because of the following informalities:
In claim 16, lines 14-17 are an identical repeat of lines 10-13; delete lines 14-17.
In claim 74, line 18, step (d) delete “comprises a variant human CD52”.
In claim 74 line 33, step (h), delete “comprises a variant human CD52”.
In claim 74, line 37, step (i), delete “comprises a variant human CD52”.
In claim 74, line 56, step (l), delete “comprises a variant human CD52”.
In claim 103, lines 14-17 are an identical repeat of lines 10-13; delete lines 14-17.
In claim 139, line 15, step (d) delete “comprises a variant human CD52”.
In claim 139, line 30, step (h), delete “comprises a variant human CD52”.
In claim 139, line 34, step (i), delete “comprises a variant human CD52”.
In claim 139, line 53, step (l), delete “comprises a variant human CD52”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 1-2, 4, 10-11, 16, 28, 37, 41, 52, 74, 87, 96-98, 103, 115, 128, 131, 139 and 174 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 considered vague and indefinite for the following reasons:
Claim 1 recites the limitation "the same mRNA" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claims 2, 4, 10-11, 16, 28, 37, 41, 52,74, 87 and 96 depend from claim 1 and are therefore included in this rejection.
Claim 4 is considered vague and indefinite for the following reasons:
In claim 4, the step identifiers (a)-(f) are unclear and confusing. The step identifiers for claim 1 are (a)-(g). It is unclear if the steps in claim 4 are referring to the (e), (d) and (f) of claim 4 or claim 1?
In claim 4, line 11, the terms “and/or” are unclear and confusing. It is unclear if steps (a) through (e) are required and only step (f) is subject to the and/or, or if (a) through (e) are also considered to be subject to the and/or? For the purposes of examination (a) through (e) are interpreted as including the “and/or” at the end of each step.
Claim 16 is considered vague and indefinite for the following reasons:
Claim 16 recites the limitation "the same mRNA" in lines 8, 22 and 30. There is insufficient antecedent basis for this limitation in the claim.
In claim 16, line 34, the terms “and/or” are unclear and confusing. It is unclear if each limitation ending in a “;” are required and only the last limitation of the claim is subject to the “and/or”, or if each limitation ending in a “;” are also considered to be subject to the and/or? For the purposes of examination each limitation ending in a “;” are interpreted as including the “and/or” at the end of each limitation within the claim.
Claim 41 is considered vague and indefinite for the following reasons:
In claim 41, line 14, the terms “and/or” are unclear and confusing. It is unclear if each limitation ending in a “;” are required and only the last limitation of the claim is subject to the “and/or”, or if each limitation ending in a “;” are also considered to be subject to the and/or? For the purposes of examination each limitation ending in a “;” are interpreted as including the “and/or” at the end of each limitation within the claim.
Claim 52 is considered vague and indefinite for the following reasons:
In claim 52, line 28, the term “or” is unclear. It is unclear if steps (a) through (j) are required and only step (k) is subject to the “or”, or if (a) through (j) are also considered to be subject to the “or”? For the purposes of examination (a) through (j) are interpreted as including the “or” at the end of each step.
Claim 74 is considered vague and indefinite for the following reasons:
In claim 74, line 55, the term “or” is unclear. It is unclear if steps (a) through (k) are required and only step (l) is subject to the “or”, or if (a) through (k) are also considered to be subject to the “or”? For the purposes of examination (a) through (k) are interpreted as including the “or” at the end of each step.
Claim 97 is considered vague and indefinite for the following reasons:
Claim 97 recites the limitation "the same mRNA" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claims 98, 103, 115, 128, 131, 139 and 174 depend from claim 97 and are therefore included in this rejection.
Claim 103 is considered vague and indefinite for the following reasons:
Claim 103 recites the limitation "the same mRNA" in lines 8, 22 and 30. There is insufficient antecedent basis for this limitation in the claim.
In claim 103, line 34, the terms “and/or” are unclear and confusing. It is unclear if each limitation ending in a “;” are required and only the last limitation of the claim is subject to the “and/or”, or if each limitation ending in a “;” are also considered to be subject to the and/or? For the purposes of examination each limitation ending in a “;” are interpreted as including the “and/or” at the end of each limitation within the claim.
Claim 128 is considered vague and indefinite for the following reasons:
In claim 128, line 14, the terms “and/or” are unclear and confusing. It is unclear if each limitation ending in a “;” are required and only the last limitation of the claim is subject to the “and/or”, or if each limitation ending in a “;” are also considered to be subject to the and/or? For the purposes of examination each limitation ending in a “;” are interpreted as including the “and/or” at the end of each limitation within the claim.
Claim 131 is considered vague and indefinite for the following reasons:
In claim 131, line 29, the term “or” is unclear. It is unclear if steps (a) through (j) are required and only step (k) is subject to the “or”, or if (a) through (j) are also considered to be subject to the “or”? For the purposes of examination (a) through (j) are interpreted as including the “or” at the end of each step.
Claim 139 is considered vague and indefinite for the following reasons:
In claim 139, line 52, the term “or” is unclear. It is unclear if steps (a) through (k) are required and only step (l) is subject to the “or”, or if (a) through (k) are also considered to be subject to the “or”? For the purposes of examination (a) through (k) are interpreted as including the “or” at the end of each step.
Claim Rejections - 35 USC § 101
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 1-2, 4, 10-11, 16, 28, 37, 41, 52, 74, 87 and 96 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions (i.e., product of nature, a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Every claimed invention must be examined to determine whether the claimed invention complies with 35 U.S.C. 101, particularly whether the claimed invention falls within a 35 U.S.C. 101 judicial exception of non-patentable subject matter (e.g., an abstract idea, law of nature, natural phenomenon, natural product etc.). Phenomena of nature, though just discovered, natural products, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work. See MPEP 2106. As per the “2019 Revised Subject Matter Eligibility Guidance” (Federal Register Vol. 84, No. 4, available 01-07-2019), claims drawn to a process, machine, manufacture or composition of matter are further analyzed according to a two-part process to determine if A) the claim(s) is/are “directed to” a judicial exception because the claims(s) recite(s) a judicial exception (i.e. prong one) that is not integrated into a practical application (i.e. prong two) and, if so, if B) the claim(s) provide(s) an inventive concept, i.e. recite(s) additional elements that amount to significantly more than the judicial exception.
Subject Matter Eligibility Test for Products and Processes
Step 1 - Is the Claim to a Process, Machine, Manufacture or Composition of Matter? YES
Claims 1-2, 4, 10-11, 16, 28, 37, 41, 52, 74, 87 and 96 are directed to one of the statutory classes. Claims 1-2, 4, 10-11, 16, 28, 37, 41, 52, 74, 87 and 96 are directed to a method for expressing a plurality of target polypeptides at a high level (Process).
Step 2A, Prong One — Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? YES
Claims 1-2, 4, 10-11, 16, 28, 37, 41, 52, 74, 87 and 96 recite the abstract ideas of receiving, analyzing and processing data using mental steps. Claims directed to nothing more than abstract ideas, natural phenomena, and laws of nature are not eligible for patent protection (see MPEP 2106.04). Abstract ideas include certain methods of organizing human activity, and mental processes (including procedures for collecting, observing, determining, evaluating, and organizing information (See MPEP 2106.04(a)(2)). In particular, these abstract ideas include:
• Selecting one or more mammalian host cells (mental process, human mind is capable of receiving/collecting data, observing/evaluating/determining and organizing information).
• Analyzing one or more clonal population (mental process, human mind is capable of receiving/collecting data, observing/evaluating/determining and organizing information).
• Detecting level of expression (mental process, human mind is capable of receiving/collecting data, observing/evaluating/determining and organizing information).
• Selecting one or more clonal populations (mental process, human mind is capable of receiving/collecting data, observing/evaluating/determining and organizing information).
Therefore, the claims recite elements that constitute one or more judicial exceptions.
Step 2A, Prong Two — Does the Claim Recite an Additional Elements that Integrate the Judicial Exception into a Practical Application? NO.
The Supreme Court has long distinguished between principles themselves, which are not patent eligible, and the integration of those principles into practical applications, which are patent eligible. However, absent are any additional elements recited in the claim beyond the judicial exceptions which integrate the exception into a practical application of the exception. The “integration into a practical application” requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
The claim analysis continues with identifying additional elements beyond the judicial exceptions that might evidence integration of the judicial exceptions into a practical application. The steps or elements in addition to the judicial exceptions are: “culturing a plurality of mammalian host cells, each comprising a plurality of recombinant polynucleotides”, “each recombinant polynucleotide comprises a promoter, a nucleotide sequence encoding a unique cell surface marker polypeptide, and a nucleotide sequence encoding a unique target polypeptide”, “contacting the cultured mammalian host cells of step (a) with a plurality of detectable agents, each uniquely capable of binding one or more of the unique cell surface marker polypeptides expressed on the surface of the mammalian host cells” and “performing at least one round of fluorescence-activated cell sorting on the contacted cells from step (b)”, which is not indicative of integration into practical application. These steps, recited at a high level of generality, comprise routine data gathering, which is considered an insignificant extra-solution activity. This data gathering is required for using the judicial exceptions. (See MPEP 2106.05(g)). There are no further/additional steps which applies either the identified judicial exception into practical application. Thus, a careful evaluation of the claim as a whole fails to reveal the practical application of the judicial exception to, e.g., effect an improvement to the functioning of a computer or other technology/technical field, effect a particular treatment or prophylaxis for a disease or medical treatment, implement a particular machine that is integral to the claim, or effect a transformation or reduction of a particular article to a different state or thing, or to apply the judicial exception in another meaningful way beyond generally linking its use to a particular technological environment. Accordingly, the claims do not integrate the judicial exception(s) into a practical application and is therefore directed to a judicial exception.
Step 2B - Does the Claim Recite Additional Elements that Amount to Significantly More than the Judicial Exception? NO.
The Supreme Court has identified a number of considerations for determining whether a claim with additional elements amounts to “significantly more” than the judicial exception(s) itself. The claims as a whole are analyzed to determine whether any additional element/step, or combination of additional elements/steps, in addition to the identified judicial exception(s) is sufficient to ensure that the claim amounts to “significantly more” than the exception(s).
The eligibility analysis proceeds with identifying any additional elements or limitations, separate from the judicial exceptions, that might potentially render the claims directed to a judicial exception patent eligible. To render the claims patent- eligible, these elements must comprise meaningful limitations that add to or transform the judicial exception to the effect that it amounts to significantly more than the natural correlation or abstract idea itself - i.e. provide an “inventive concept’. The elements that are in addition to the judicial exception comprise: culturing a plurality of mammalian host cells, each comprising a plurality of recombinant polynucleotides, each recombinant polynucleotide comprises a promoter, a nucleotide sequence encoding a unique cell surface marker polypeptide, and a nucleotide sequence encoding a unique target polypeptide, contacting the cultured mammalian host cells of step (a) with a plurality of detectable agents, each uniquely capable of binding one or more of the unique cell surface marker polypeptides expressed on the surface of the mammalian host cells and performing at least one round of fluorescence-activated cell sorting on the contacted cells from step (b). When considered separately and in combination, these elements do not add significantly more to the judicial exception. These steps are well-understood, routine and conventional activities in the field. For example, Cairns et al. (WIPO International Application Publication WO 2017/062722 A2, published April 13, 2017), cited on the IDS filed April 08, 2025, discloses culturing a plurality of mammalian host cells, each comprising a plurality of recombinant polynucleotides, each recombinant polynucleotide comprises a promoter, a nucleotide sequence encoding a unique cell surface marker polypeptide, and a nucleotide sequence encoding a unique target polypeptide, contacting the cultured mammalian host cells of step (a) with a plurality of detectable agents, each uniquely capable of binding one or more of the unique cell surface marker polypeptides expressed on the surface of the mammalian host cells and performing at least one round of fluorescence-activated cell sorting on the contacted cells from step (b). The claims recite an abstract idea with additional elements. Because these elements are not inventive concepts, the claims do not integrate the abstract idea into a practical application. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). The claims therefore do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Accordingly, the claims do not qualify as patent-eligible subject matter.
For further information, please see the latest revision of MPEP 2104-2106 {Patent Subject Matter Eligibility Under 35 U.S.C. 101}, including MPEP 2106.04 {Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception} and 2106.05 {Eligibility Step 2B: Whether a Claim Amounts to Significantly More}, as well as the guidance on Subject Matter Eligibility, including the 2019 Guidance issued Jan. 7, 2019, and the October 2019 Update, provided on the USPTO website at https:/Awww.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter- eligibility.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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 1-2, 4, 10-11, 16, 28, 37, 41, 87, 96-98, 103, 115, 128 and 174 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Cairns et al. (WIPO International Application Publication WO 2017/062722 A2, published April 13, 2017), cited on the IDS filed April 08, 2025.
Regarding claim 1, Cairns teaches a method for expressing a plurality of target polypeptides at a high level (Page 25, Last Paragraph). Cairns teaches culturing a plurality of mammalian host cells (Page 32, Second Paragraph and Page 33, Last Paragraph). Cairns teaches a plurality of recombinant polynucleotides (Page 17, Second Paragraph, Page 29, Second Paragraph and Page 31, Second Paragraph). Cairns teaches each recombinant polynucleotide comprises a promoter, a nucleotide sequence encoding a unique cell surface marker polypeptide, and a nucleotide sequence encoding a unique target polypeptide (Page 31, Second Paragraph, Page 21, First—Second Paragraph, Page 25, Last Paragraph—Page 26, First Paragraph and Page 22, Second—Fifth Paragraph). Cairns teaches both the nucleotide sequence encoding the unique cell surface marker polypeptide and the nucleotide sequence encoding the unique target polypeptide are transcribed on the same mRNA (Page 2, First Paragraph, Page 5, First and Last Paragraphs, Page 21, Second Paragraph and Page 25, Second Paragraph). Cairns teaches the culturing is under conditions that permit expression of each unique cell surface marker polypeptide on the surface of the mammalian host cells and expression of each unique target polypeptide (Page 22, Second Paragraph, Page 25, Last Paragraph—Page 26, First Paragraph, Page 32, Second Paragraph and Page 33, Last Paragraph). Cairns teaches contacting the cultured mammalian host cells of step (a) with a plurality of detectable agents, each uniquely capable of binding one or more of the unique cell surface marker polypeptides expressed on the surface of the mammalian host cells (Page 17, Last Paragraph, Page 22, Last Paragraph—Page 23, Fourth Paragraph, Page 25, Second Paragraph—Page 26, First Paragraph, Page 32, Second Paragraph and Page 33, Last Paragraph). Cairns teaches performing at least one round of fluorescence-activated cell sorting on the contacted cells from step (b), thereby selecting one or more mammalian host cells that are uniquely bound by at least one of the plurality of detectable agents (Page 17, Last Paragraph, Page 21, First—Seventh Paragraph, Page 22, Last Paragraph—Page 23, Fourth Paragraph, Page 25, Second Paragraph, Page 26, First Paragraph, Page 32, Second Paragraph and Page 33, Last Paragraph). Cairns teaches preparing one or more clonal populations of the mammalian host cells selected in step (c) (Abstract, Page 2, Last Paragraph Page 4, Fourth Paragraph, Page 10, First Paragraph and Page 32, Second Paragraph and Page 33, Last Paragraph). Cairns teaches analyzing one or more clonal populations from step (d) by detecting level of expression of at least two unique cell surface marker polypeptides on each of said clonal populations (Page 4, Third—Fourth Paragraph, Page 10, First Paragraph, Page 22, Second Paragraph—Fourth Paragraph, Page 25, Last Paragraph—Page 26, Second Paragraph and Figs. 23-24). Cairns teaches selecting one or more clonal populations having high expression level of the at least two unique cell surface marker polypeptides (Page 4, Third—Fourth Paragraph, Page 10, First Paragraph, Page 22, Second Paragraph—Fourth Paragraph, Page 25, Last Paragraph—Page 26, Second Paragraph and Figs. 23-24). Cairns teaches culturing one or more clonal populations selected in step (f) under conditions that permit expression of the plurality of target polypeptides at a high level (Page 4, Third—Fourth Paragraph, Page 10, First Paragraph, Page 22, Second Paragraph—Fourth Paragraph, Page 25, Last Paragraph—Page 26, Second Paragraph and Figs. 23-24).
Regarding claim 2, Cairns teaches performing a single round of fluorescence-activated cell sorting on the contacted cells from step (b) with at least a first detectable agent and a second detectable agent, thereby selecting one or more mammalian host cells that are uniquely bound by at least both the first detectable agent and the second detectable agent (Page 17, Last Paragraph, Page 22, Last Paragraph—Page 23, Fourth Paragraph, Page 25, Second Paragraph—Page 26, First Paragraph, Page 32, Second Paragraph and Page 33, Last Paragraph).
Regarding claim 4, Cairns teaches step (e) is performed 7-28 days after step (d) (Page 25, Second Paragraph—Page 26, First Paragraph). Cairns teaches the analyzing in step (e) comprises flow cytometry (Title and Page 17, Last Paragraph). Cairns teaches the expression level of at least one of the plurality of unique cell surface marker polypeptides in step (f) is higher than a corresponding expression level of at least 70 % of the clonal populations analyzed in step (e) (Page 2, First—Second Paragraph, Page 21, First—Third Paragraph, Page 25, Last Paragraph). Cairns teaches the expression level of each of the plurality of unique cell surface marker polypeptides in step (f) is higher than a corresponding expression level of at least 70 % of the clonal populations analyzed in step (e) (Page 2, First—Second Paragraph, Page 21, First—Third Paragraph, Page 25, Last Paragraph). Cairns teaches the expression level of at least a first of the plurality of unique cell surface polypeptides in step (f) is higher than the expression level of at least a second of the plurality of unique cell surface polypeptides in step (f) (Page 2, First—Second Paragraph, Page 21, First—Third Paragraph, Page 25, Last Paragraph).
Regarding claim 10, Cairns teaches isolating at least a first unique target polypeptide and a second unique target polypeptide expressed in step (g) from the one or more selected clonal populations or from cell culture medium in which the one or more selected clonal populations are cultured (Page 2, Last Paragraph, Page 26, First Paragraph, Page 27, Third Paragraph and Page 36, First Paragraph).
Regarding claim 11, Cairns teaches the plurality of unique target polypeptides comprises 2 to 8 unique target polypeptides (Page 45, Second Paragraph).
Regarding claim 16, Cairns teaches each recombinant polynucleotide comprises, from 5' to 3', the promoter, the nucleotide sequence encoding the unique cell surface marker polypeptide, and the nucleotide sequence encoding the unique target polypeptide (Page 31, Second Paragraph, Page 21, First—Second Paragraph, Page 25, Last Paragraph—Page 26, First Paragraph, Page 22, Second—Fifth Paragraph, Page 41, First Paragraph and Fig. 1). Cairns teaches each recombinant polynucleotide comprises 1 to 4 promoters (Page 31, Last Two Paragraphs). Cairns teaches 1 to 4 nucleotide sequences each encoding a unique cell surface marker polypeptide and 1 to 4 nucleotide sequences each encoding a unique target polypeptide (Page 21, Second—Fifth Paragraph and Page 45, Second Paragraph). Cairns teaches one of the nucleotide sequences encoding a unique cell surface marker polypeptide is transcribed on the same mRNA as one of the nucleotide sequences encoding a unique target polypeptide (Page 2, First Paragraph, Page 5, First and Last Paragraphs, Page 21, Second Paragraph and Page 25, Second Paragraph). Cairns teaches each recombinant polynucleotide is a bicistronic polynucleotide comprising two promoters and two nucleotide sequences each encoding a unique target polypeptide, and further comprising one or two nucleotide sequences each encoding a unique cell surface marker polypeptide (Page 22, Second—Fifth Paragraph, Page 31, Last Paragraph—Page 32, Last Paragraph and Example 1). Cairns teaches each bicistronic polynucleotide comprises a single nucleotide sequence encoding a unique cell surface marker polypeptide (Page 22, Second—Fifth Paragraph, Page 29, Second Paragraph and Example 1). Cairns teaches each bicistronic polynucleotide comprises two nucleotide sequences each encoding a unique cell surface marker polypeptide, and each one of the nucleotide sequences encoding a unique cell surface marker polypeptide is transcribed on the same mRNA as one of the nucleotide sequences encoding a unique target polypeptide (Page 2, First Paragraph, Page 5, First and Last Paragraphs, Page 21, Second Paragraph, Page 25, Second Paragraph and Example 1). Cairns teaches each recombinant polynucleotide comprises, from 5' to 3', one of the from 1-4 promoters, one of the from 1-4 nucleotide sequences encoding a unique cell surface marker polypeptide, and one of the from 1-4 nucleotide sequences encoding a unique target polypeptide (Page 31, Second Paragraph, Page 21, First—Second Paragraph, Page 25, Last Paragraph—Page 26, First Paragraph, Page 22, Second—Fifth Paragraph, Page 41, First Paragraph and Fig. 1). Cairns teaches each recombinant polynucleotide comprises one promoter, one nucleotide sequence encoding a unique cell surface marker polypeptide, and one nucleotide sequence encoding a unique target polypeptide, and the nucleotide sequence encoding a unique cell surface marker polypeptide is transcribed on the same mRNA as the nucleotide sequence encoding a unique target polypeptide (Page 2, First Paragraph, Page 5, First and Last Paragraphs, Page 21, Second Paragraph and Page 25, Second Paragraph). Cairns teaches each recombinant polynucleotide further comprises an internal ribosome entry site (IRES) located 3' to the nucleotide sequence encoding the unique cell surface marker polypeptide and 5' to the nucleotide sequence encoding the unique target polypeptide (Page 30, Second Paragraph).
Regarding claim 28, Cairns teaches at least a first recombinant polynucleotide comprises, from 5' to 3', a first promoter, a nucleotide sequence encoding a first unique cell surface marker polypeptide, and a nucleotide sequence encoding a first unique target polypeptide (Page 31, Second Paragraph, Page 21, First—Second Paragraph, Page 25, Last Paragraph—Page 26, First Paragraph, Page 22, Second—Fifth Paragraph, Page 41, First Paragraph and Fig. 1).
Regarding claim 37, Cairns teaches at least one promoter is a β -actin promoter, each promoter is a β -actin promoter, at least one promoter is a hamster β-actin promoter, or each promoter is a hamster β -actin promoter (Page 41, First Paragraph).
Regarding claim 41, Cairns teaches at least a first unique cell surface marker polypeptide is selected from the group consisting of CD20, CD52, CD59, and variants thereof (Page 2, First Paragraph and Page 22, Second—Fifth Paragraph). Cairns teaches at least a second unique cell surface marker polypeptide is selected from the group consisting of CD20, CD52, CD59, and variants thereof (Page 2, First Paragraph and Page 22, Second—Fifth Paragraph). Cairns teaches each unique cell surface marker polypeptide is selected from the group consisting of CD20, CD52, CD59, and variants thereof (Page 2, First Paragraph and Page 22, Second—Fifth Paragraph). Cairns teaches at least a first unique cell surface marker polypeptide is selected from the group consisting of human CD52 and variants thereof (Page 2, First Paragraph and Page 22, Second—Fifth Paragraph). Cairns teaches at least a second unique cell surface marker polypeptide is selected from the group consisting of human CD52 and variants thereof (Page 2, First Paragraph and Page 22, Second—Fifth Paragraph). Cairns teaches each unique cell surface marker polypeptide is selected from the group consisting of human CD52 and variants thereof (Page 2, First Paragraph and Page 22, Second—Fifth Paragraph). Cairns teaches at least a first unique cell surface marker polypeptide is human CD52 or at least a second unique cell surface marker polypeptide is human CD52 (Page 2, First Paragraph and Page 22, Second—Fifth Paragraph).
Regarding claim 87, Cairns teaches at least one unique target polypeptide comprises a therapeutic polypeptide or a therapeutic protein (Page 2, First Paragraph, Page 18, Second Paragraph and Fig. 1).
Regarding claim 96, Cairns teaches the recombinant mammalian host cell is a CHO cell (Page 28, Third Paragraph, Page 38, Second Paragraph and Page 48, Second Paragraph).
Regarding claim 97, Cairns teaches an engineered mammalian host cell comprising a plurality of recombinant polynucleotides (Page 18, Last Paragraph, Page 29, Second Paragraph, Page 32, Second—Third Paragraph and Page 33, First—Second Paragraph). Cairns teaches each recombinant polynucleotide comprises a promoter, a nucleotide sequence encoding a unique cell surface marker polypeptide, and a nucleotide sequence encoding a unique target polypeptide (Page 31, Second Paragraph, Page 21, First—Second Paragraph, Page 25, Last Paragraph—Page 26, First Paragraph and Page 22, Second—Fifth Paragraph). Cairns teaches both the nucleotide sequence encoding the unique cell surface marker polypeptide and the nucleotide sequence encoding the unique target polypeptide are transcribed on the same mRNA (Page 2, First Paragraph, Page 5, First and Last Paragraphs, Page 21, Second Paragraph and Page 25, Second Paragraph).
Regarding claim 98, Cairns teaches the plurality of unique target polypeptides comprises 2 to 8 unique target polypeptides (Page 45, Second Paragraph).
Regarding claim 103, Cairns teaches each recombinant polynucleotide comprises, from 5' to 3', the promoter, the nucleotide sequence encoding the unique cell surface marker polypeptide, and the nucleotide sequence encoding the unique target polypeptide (Page 31, Second Paragraph, Page 21, First—Second Paragraph, Page 25, Last Paragraph—Page 26, First Paragraph, Page 22, Second—Fifth Paragraph, Page 41, First Paragraph and Fig. 1). Cairns teaches each recombinant polynucleotide comprises 1 to 4 promoters (Page 31, Last Two Paragraphs). Cairns teaches 1 to 4 nucleotide sequences each encoding a unique cell surface marker polypeptide and 1 to 4 nucleotide sequences each encoding a unique target polypeptide (Page 21, Second—Fifth Paragraph and Page 45, Second Paragraph). Cairns teaches one of the nucleotide sequences encoding a unique cell surface marker polypeptide is transcribed on the same mRNA as one of the nucleotide sequences encoding a unique target polypeptide (Page 2, First Paragraph, Page 5, First and Last Paragraphs, Page 21, Second Paragraph and Page 25, Second Paragraph). Cairns teaches each recombinant polynucleotide is a bicistronic polynucleotide comprising two promoters and two nucleotide sequences each encoding a unique target polypeptide, and further comprising one or two nucleotide sequences each encoding a unique cell surface marker polypeptide (Page 22, Second—Fifth Paragraph, Page 31, Last Paragraph—Page 32, Last Paragraph and Example 1). Cairns teaches each bicistronic polynucleotide comprises a single nucleotide sequence encoding a unique cell surface marker polypeptide (Page 22, Second—Fifth Paragraph, Page 29, Second Paragraph and Example 1). Cairns teaches each bicistronic polynucleotide comprises two nucleotide sequences each encoding a unique cell surface marker polypeptide, and each one of the nucleotide sequences encoding a unique cell surface marker polypeptide is transcribed on the same mRNA as one of the nucleotide sequences encoding a unique target polypeptide (Page 2, First Paragraph, Page 5, First and Last Paragraphs, Page 21, Second Paragraph, Page 25, Second Paragraph and Example 1). Cairns teaches each recombinant polynucleotide comprises, from 5' to 3', one of the from 1-4 promoters, one of the from 1-4 nucleotide sequences encoding a unique cell surface marker polypeptide, and one of the from 1-4 nucleotide sequences encoding a unique target polypeptide (Page 31, Second Paragraph, Page 21, First—Second Paragraph, Page 25, Last Paragraph—Page 26, First Paragraph, Page 22, Second—Fifth Paragraph, Page 41, First Paragraph and Fig. 1). Cairns teaches each recombinant polynucleotide comprises one promoter, one nucleotide sequence encoding a unique cell surface marker polypeptide, and one nucleotide sequence encoding a unique target polypeptide, and the nucleotide sequence encoding a unique cell surface marker polypeptide is transcribed on the same mRNA as the nucleotide sequence encoding a unique target polypeptide (Page 2, First Paragraph, Page 5, First and Last Paragraphs, Page 21, Second Paragraph and Page 25, Second Paragraph). Cairns teaches each recombinant polynucleotide further comprises an internal ribosome entry site (IRES) located 3' to the nucleotide sequence encoding the unique cell surface marker polypeptide and 5' to the nucleotide sequence encoding the unique target polypeptide (Page 30, Second Paragraph).
Regarding claim 115, Cairns teaches at least a first recombinant polynucleotide comprises, from 5' to 3', a first promoter, a nucleotide sequence encoding a first unique cell surface marker polypeptide, and a nucleotide sequence encoding a first unique target polypeptide (Page 31, Second Paragraph, Page 21, First—Second Paragraph, Page 25, Last Paragraph—Page 26, First Paragraph, Page 22, Second—Fifth Paragraph, Page 41, First Paragraph and Fig. 1).
Regarding claim 128, Cairns teaches at least a first unique cell surface marker polypeptide is selected from the group consisting of CD20, CD52, CD59, and variants thereof (Page 2, First Paragraph and Page 22, Second—Fifth Paragraph). Cairns teaches at least a second unique cell surface marker polypeptide is selected from the group consisting of CD20, CD52, CD59, and variants thereof (Page 2, First Paragraph and Page 22, Second—Fifth Paragraph). Cairns teaches each unique cell surface marker polypeptide is selected from the group consisting of CD20, CD52, CD59, and variants thereof (Page 2, First Paragraph and Page 22, Second—Fifth Paragraph). Cairns teaches at least a first unique cell surface marker polypeptide is selected from the group consisting of human CD52 and variants thereof (Page 2, First Paragraph and Page 22, Second—Fifth Paragraph). Cairns teaches at least a second unique cell surface marker polypeptide is selected from the group consisting of human CD52 and variants thereof (Page 2, First Paragraph and Page 22, Second—Fifth Paragraph). Cairns teaches each unique cell surface marker polypeptide is selected from the group consisting of human CD52 and variants thereof (Page 2, First Paragraph and Page 22, Second—Fifth Paragraph). Cairns teaches at least a first unique cell surface marker polypeptide is human CD52 or at least a second unique cell surface marker polypeptide is human CD52 (Page 2, First Paragraph and Page 22, Second—Fifth Paragraph).
Regarding claim 174, Cairns teaches at least one unique target polypeptide comprises a therapeutic polypeptide or a therapeutic protein (Page 2, First Paragraph, Page 18, Second Paragraph and Fig. 1).
Cairns teaches each and every limitation of claims 1-2, 4, 10-11, 16, 28, 37, 41, 87, 96-98, 103, 115, 128 and 174, therefore Cairns anticipates claims 1-2, 4, 10-11, 16, 28, 37, 41, 87, 96-98, 103, 115, 128 and 174.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 52, 74, 131, 139 and 184 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts et al. (U.S. Patent Application Publication US 2012/0100152 A1, published April 26, 2012).
Regarding claims 52, 74, 131, 139 and 184, Cairns at least one unique cell surface marker polypeptide is a variant human CD52 comprising the amino acid sequence set forth in SEQ ID NO: 22 (GQNDTSQXsSSPS) (Page 22, Third Paragraph, see exemplary variant Human CD52 amino acid sequence, SEQ ID NO: 1).
Cairns does not teach or suggest at least one unique cell surface marker polypeptide is a variant human CD52 comprising the amino acid sequence set forth in SEQ ID NO: 22 (GQNDTSQXsSSPS) wherein Xs is A. Cairns does not teach or suggest a variant human CD52 comprising the amino acid sequence set forth in SEQ ID NO: 2 (GANDTSQTSSPS) and at least a second unique cell surface marker polypeptide comprises a variant human CD52 comprising an amino acid sequence selected from the group consisting of SEQ ID NO: 4 (GQNATSQTSSPS) and SEQ ID NO: 7 (GQNDTSATSSPS).
Roberts teaches using cultured engineered mammalian host cells (Page 31, [0369], Page 63, [0541] and Example 4). Roberts teaches isolating a target (Page 21, [0269]-[0270]). Roberts teaches using FACS analysis to detect the surface cell marker CD52 for therapeutic purposes (Page 9, [0066] and Pages 27-28, [0337]). Roberts teaches at least one unique cell surface marker polypeptide is a variant human CD52 comprising the amino acid sequence set forth in SEQ ID NO: 22 (GQNDTSQXsSSPS) wherein Xs is A (Page 63, [0541] and Table 21). Roberts teaches a variant human CD52 comprising the amino acid sequence set forth in SEQ ID NO: 2 (GANDTSQTSSPS) and at least a second unique cell surface marker polypeptide comprises a variant human CD52 comprising an amino acid sequence selected from the group consisting of SEQ ID NO: 4 (GQNATSQTSSPS) and SEQ ID NO: 7 (GQNDTSATSSPS)(Page 63, [0541] and Table 21).
As a common field of endeavor both Cairns and Roberts disclose methods using FACS analysis to detect a variant human surface cell marker CD52 for therapeutic purposes.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have modified Cairns to incorporate the teachings of Roberts, to use a variant human CD52 comprising the amino acid sequence set forth in SEQ ID NO: 22 (GQNDTSQXsSSPS) wherein Xs is A, and/or a variant human CD52 comprising the amino acid sequence set forth in SEQ ID NO: 2 (GANDTSQTSSPS) and at least a second unique cell surface marker polypeptide comprises a variant human CD52 comprising an amino acid sequence selected from the group consisting of SEQ ID NO: 4 (GQNATSQTSSPS) and SEQ ID NO: 7 (GQNDTSATSSPS) because in accordance with MPEP 2141 section Ill (A) citing KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385, 1395 (2007) combining prior art elements according to known methods to yield predictable results is obvious. It would have been prima facie obvious to one of ordinary skill in the art to select a variant human CD52 comprising any amino acid sequence that is capable of being used in the system of Cairns. There is a reasonable expectation of success of combing Cairns and Roberts because both use FACS analysis to detect a variant human surface cell marker CD52 for therapeutic purposes, therefore the amino acid sequences of Roberts are well suited for the system of Cairns.
Conclusion
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/JESSICA D PARISI/ Examiner, Art Unit 1684 /HEATHER CALAMITA/ Supervisory Patent Examiner, Art Unit 1684
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