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 .
Claim Status
Applicant’s preliminary amendments received 11NOV2024 are acknowledged.
Claims 1-100 have been canceled.
Claim 101 is new.
Claim 101 (i.e., Claim 101 is independent) is pending in the instant application and under examination.
Priority
The present application is a 371 National Stage of PCT International Application No. PCT/US21/64263, filed 20DEC2021, which claims the benefit of US Provisional Patent Application No. 63/219402, filed 08JUL2021 and US Provisional Patent Application No. 63/129893, filed 23DEC2020. Applicant’s claim for the benefit of prior-filed application is acknowledged.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 29MAY2024 is/are acknowledged and the references cited therein have been considered.
Specification
The disclosure is objected to because of the following informalities:
CROSS-REFERENCES TO RELATED APPLICATIONS section needs to be updated to include 371 National Stage of PCT International Application No. PCT/US21/64263, filed 20DEC2021.
Appropriate correction is required.
Claim Objections
Claim 101 is objected to because of the following informalities:
Claim 101 contains the acronym MALDI. While acronyms are permissible as shorthand in the claims, the first recitation of the term should include the full recitation followed by the acronym in parentheses. Appropriate correction is required.
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.
Claim 101 is rejected under 35 U.S.C. 101 because the claimed inventions are not directed to patent eligible subject matter. After consideration of relevant factors with respect to claim(s) 1 as a whole, the claim is directed to an abstract idea and a natural phenomenon without significantly more. The rationale for this determination is explained below:
Because abstract ideas, laws of nature, and natural phenomenon "are the basic tools of scientific and technological work", the Supreme Court has expressed concern that monopolizing these tools by granting patent rights may impede innovation rather than promote it. See Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980; Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012). However, the Court has also emphasized that an invention is not considered to be ineligible for patenting simply because it involves a judicial exception. Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1980-81 (citing Diamond v. Diehr, 450 U.S. 175, 187, 209 USPQ 1, 8 (1981)). Accordingly, the Court has said that integration of an abstract idea, law of nature or natural phenomenon into a practical application may be eligible for patent protection. See, e.g., Alice, 573 U.S. at 217, 110 USPQ2d at 1981 (explaining that "in applying the §101 exception, we must distinguish between patents that claim the ‘buildin[g] block[s]’ of human ingenuity and those that integrate the building blocks into something more" (quoting Mayo, 566 U.S. at 89, 110 USPQ2d at 1971) and stating that Mayo "set forth a framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts"); Mayo, 566 U.S. at 80, 84, 101 USPQ2d at 1969, 1971 (noting that the Court in Diamond v. Diehr found "the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole." See MPEP §2016.
STEP 1: Is the claim to a process, machine, manufacture, or composition of matter?
Claim 101is drawn to a process.
[Step 1: Claim 101: yes]
STEP 2A (1st prong): Do the claims recite a judicially-recognized exception (JE), e.g., a law of nature, a natural phenomenon or product, or an abstract idea?
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." See MPEP §2106.04(b).
Law of Nature recitation in claim 101: “protein” under BRI this recitation is considered to be a “product of nature” in accordance with University of Utah Research Foundation v Ambry Genetics, 774 F.3d 755-760. In this instance, “protein” is considered to be a product of nature because the generic nature of the protein as claimed, is structurally identical to any naturally occurring protein.
The abstract idea exception has deep roots in the Supreme Court’s jurisprudence. See Bilski v. Kappos, 561 U.S. 593, 601-602, 95 USPQ2d 1001, 1006 (2010) (citing Le Roy v. Tatham, 55 U.S. (14 How.) 156, 174–175 (1853)). Despite this long history, the courts have declined to define abstract ideas. However, it is clear from the body of judicial precedent that software and business methods are not excluded categories of subject matter. The enumerated groupings are firmly rooted in Supreme Court precedent as well as Federal Circuit decisions interpreting that precedent, as is explained in MPEP § 2106.04(a)(2).
The enumerated groupings of abstract ideas are defined as:
1) Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations (see MPEP § 2106.04(a)(2), subsection I);
2) Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (see MPEP § 2106.04(a)(2), subsection II); and
3) Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).
Abstract Idea recitation in claim 101: “analyzing the protein by MALDI-TOF MS” under BRI this step is considered an abstract idea in the “mental processes” group. For example, analysis of collected information (i.e., mass of a generic protein) is an act of evaluating information that can be practically performed in the human mind.
[Step 2A (1st prong): Claim 101: yes]
STEP 2A (2nd prong): Do the claims recite additional elements that integrate the judicial exception into a practical application?
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). See, e.g., Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012) (noting that the Court in Diamond v. Diehr found ‘‘the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole,’’ but the Court in Gottschalk v. Benson ‘‘held that simply implementing a mathematical principle on a physical machine, namely a computer, was not a patentable application of that principle’’). The Supreme Court and Federal Circuit have identified a number of considerations as relevant to the evaluation of whether the claimed additional elements demonstrate that a claim is directed to patent-eligible subject matter.
Limitations the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:
• An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
• Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
• Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
• Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
• Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
The courts have also identified limitations that did not integrate a judicial exception into a practical application:
• Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984 (see MPEP § 2106.05(f));
• Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d));
• Adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea such as a step of obtaining information about credit card transactions so that the information can be analyzed by an abstract mental process, as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (see MPEP § 2106.05(g)); or
• Generally linking the use of the judicial exception to a particular technological environment or field of use, e.g., a claim describing how the abstract idea of hedging could be used in the commodities and energy markets, as discussed in Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1010 (2010) or a claim limiting the use of a mathematical formula to the petrochemical and oil-refining fields, as discussed in Parker v. Flook, 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) (MPEP § 2106.05(h)).
At this point in examination, the identified JEs are not integrated into a practical application because determining the mass of a protein comprising the steps of analyzing the protein by MALDI-TOF MS, is appending a well understood and routine method for analyzing the mass of proteins.
[Step 2A (2nd prong): Claim 101: no]
STEP 2B: Do the claims recite a non-conventional arrangement of additional elements that amounts to significantly more than the judicial exception (i.e., Do the additional elements contribute an “inventive concept”?
The second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)).
All elements of claim 101 are part of one or more identified JEs (as described above) and do not contain additional elements that are sufficient to amount to significantly more than the judicial exception because each element/step when considered independently an in combination are considered a conventional and routine method of determining the mass of a protein. Furthermore, Webster, et al., (Chemical Genomics and Proteomic, Ch 15, 2011, 227-240), teaches that MALDI-TOF MS are now commonplace and their relative ease of use means that most non-specialist labs can readily access the technology for the rapid and sensitive analysis of biomolecules (i.e., a method of determining the mass of a protein) (Abstract) consisting of the elements/steps of claim 101 (i.e., analyzing the protein by MALDI-TOF MS).
[Step 2B: Claim 101: no]
Summary and conclusion regarding claim 101:
In conclusion, the above 101 JE analysis of claim 101, viewed as a whole and considering all elements individually and in combination, no claim recites limitations that transform the claim, finally interpreted as directed to the above-identified JE(s), into patent eligible subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 101 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Signor, et al., (JOVE, 2013, 79, 1-7), herein referred to as “Signor.”
Signor teaches that MALDI-TOF MS can be used to identify intact proteins and their masses larger than 100 kDa by analyzing the protein by MALDI-TOF MS (see entire article, see abstract, Fig 3).
Therefore, the prior art anticipates the invention as presently claimed.
Claim 101 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2017/0108509 A1 (Parker, et al., 20APR2017), herein referred to as “’509.”
‘509 teaches method of identifying the masses of ribosomal proteins of microorganisms by MALDI-TOF (see claim 4).
Therefore, the prior art anticipates the invention as presently claimed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 101 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 12,371,475 B2, herein referred to as “’475.” Although the claims at issue are not identical, they are not patentably distinct from each other because product wherein the mass of each antigen-binding protein is determined by MALDI-TOF MS of the ‘475 patent anticipates the method of determining the mass of a protein comprising analyzing the protein by MALDI-TOF MS of the instant application.
The ’475 patent claims recite: A recombinant nucleic acid molecule comprising a modified immunoglobulin (Ig) variable (V) gene segment that encodes an anchor-modified Ig polypeptide, wherein the modified Ig V gene segment comprises a nucleic acid sequence encoding the anchor between a nucleic acid sequence encoding an Ig signal peptide and a nucleic acid sequence encoding the framework region (FR) 1, complementarity determining region (CDR) 1, FR2, CDR2, FR3, and CDR3 of a germline Ig V gene segment, or a variant thereof, wherein the anchor-modified Ig polypeptide comprises, in operable linkage: (i) the Ig signal peptide, (ii) the anchor, and (iii) the FR1, CDR1, FR2, CDR2, FR3, and CDR3 of the germline Ig V gene segment, or a variant thereof, wherein the anchor comprises a receptor binding portion of a non-immunoglobulin polypeptide of interest that binds a cognate receptor, and optionally wherein the nucleic acid molecule lacks any other Ig V gene segments (i.e., claim 1). An antigen-binding protein comprising an anchor-modified Ig polypeptide encoded by the recombinant nucleic acid molecule of claim 1, optionally: wherein the mass of each antigen-binding protein confirms the presence of the anchor-modified Ig polypeptide, wherein the mass of each antigen-binding protein is determined by Matrix-Assisted Laser Desorption Ionization—Time of Flight Mass Spectrometry, or wherein the mass of each antigen-binding protein confirms the presence of the anchor-modified Ig polypeptide and the mass of each antigen-binding protein is determined by Matrix-Assisted Laser Desorption Ionization—Time of Flight Mass Spectrometry (i.e., claim 26). The antigen-binding protein comprising the anchor-modified Ig polypeptide of claim 26 comprising an amino acid sequence set forth as SEQ ID NO:3 at its N-terminus (i.e., claim 27).
In this instance, because the mass of the protein is determined by MALDI-TOF MS, there is no clear difference in the scope between the analysis of the protein of the instant application and the ’475 patent.
Conclusion
Claim 101 is not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. HOPKINS whose telephone number is (703)756-4666. The examiner can normally be reached Mon-Thurs 6:00 AM to 4:00 PM EST.
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/SAMANTHA LAKE HOPKINS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641