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 .
Election/Restrictions
Applicant's election with traverse of Group I and the species of DNase and “all antibodies disclosed in paragraph [0091] in the reply filed on 20 April 2026 is acknowledged. The traversal is on the ground(s) that the Office has not demonstrated a serious burden would be required to examine all the claims. This is not found persuasive because For purposes of the initial requirement, a serious burden on the examiner may be prima facie shown by appropriate explanation of separate classification, or separate status in the art, or a different field of search as defined in MPEP § 808.02. The separate classifications were clearly demonstrated in the previous Office action. The traversal of the species is that all antibodies are used simultaneously. This is not persuasive because the claims recite “at least a first targeting moiety and a second targeting moiety, wherein the first targeting moiety interacts with a first specific protein of interest and the second targeting moiety interacts with a second protein of interest in the cell or tissue sample … at least one detectable signal is produced”. Thus, contrary to Applicant’s assertions, the claims clearly do not contemplate using all antibodies listed, but rather one at a time. As stated in the previous Office action, where Applicant elects a group of species, Applicant is stating on the record that the grouping consists of “patentably indistinct species”, which is defined in the MPEP as obvious variants of one another, such that prior art that teaches any one, renders obvious the rest of the species. See MPEP 803.02(III)(C)(1).
Therefore, the requirement is still deemed proper and is therefore made FINAL.
Claims 45-48 and 51-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-5, 11-16, 18, 20 and 22 are examined upon their merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application claims the benefit of US Provisional Application No. 63/399,427, filed on 19 August 2022.
Claims 1-5, 11-16, 18, 20 and 22 have an effective filing date of 19 August 2022.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 8 December 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The listing of references in the specification (see pages 94-115) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (i.e. citation 61, page 99). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
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 1-5, 11-16, 18, 20 and 22 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 recites: “at least a first targeting moiety and a second targeting moiety.” MPEP 2173.05(c)(III) states open-ended ranges coupled with “at least” may be indefinite. The phrasing renders the claim unclear as to whether one (“at least a first”, which is singular) or two moieties (at least two comprising each a first and a second moieties) are required. This renders the scope of all depending claims unclear, for example, claim 2, which depends from claim 1, states: “each of the at least two” even though the parent claim recites “at least a” (one) singular moiety, which is further rendered indefinite because the singular moiety comprises an “antibody and an oligonucleotide”, which appear to be a conjugate rather than a single moiety. For purposes of applying prior art, the claim will be interpreted as requiring at least two conjugates each comprising an antibody and an oligonucleotide, and language along those lines is suggested in order to obviate this rejection.
Claim 1 is further indefinite wherein it recites: “wherein an interaction between the first specific protein of interest and the second specific protein of interest causes the first targeting moiety and second targeting moiety to be in close proximity to each other, wherein when the first targeting moiety and the second targeting moiety are in close proximity to each other, at least one detectable signal is produced”. This is an intended result that is not an positively stated, active step. Indeed, “at least one detectable signal is produced” is entirely passive, not an active method step – this may be obviated by rolling the steps in Claim 3 for “producing” into Claim 1. The sole active step of part (a) is “applying”, and the rest is merely an intended result that inherently occurs subsequent to that “applying”. It is unclear what methodological or structural limitations are required for there to be an interaction between the first specific protein of interest and the second specific protein, such that they are in close proximity to each other, and, presumably, the detectable signal is produced. It is unclear how a person having ordinary skill in the art would know- after applying the two moieties of the claims - when the interaction or the close proximity has occurred; or, whether or not identifying an interaction/proximity/detectable signal, is required for direct infringement of the invention. MPEP 2173.05(g) states: “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim’ and thus be indefinite.” It further states: “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim” (emphasis added). Since the claim fails to meet all (3) criteria set forth in MPEP 2173.05(g), then it is rejected as being indefinite. This affects the scope of all depending claims, as well.
Similarly, Claim 14 is indefinite wherein it attempts to limit the at least one imaging moiety by functional language “which can interact…wherein when the at least one imaging moiety interacts … it produces a detectable signal.” None of these impose a structural/material limitation upon the moiety itself. Functional limitations can only provide a patentable distinction (limit the claim scope) by imposing limits on the function of a structure, material or action. Here, there are no such limits, thus the scope of the recitation is indefinite. In re Fullam (161 F.2d 247 (C.C.P.A. 1947) the court held that the USPTO properly rejected certain patent claims as being functional, and rationalized the rejection by stating that the article in question was defined “not in terms of what it is, but of what it does.” (Id. at 249. (citing General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364 (1938)). The case law applies to the instant claim, which fails to further limit the imaging moiety by structure, claiming it by what it does rather than what it is.
Claims 1 and 14 are indefinite wherein they recite: “deactivating” the signal, without setting forth those active steps whereby this is achieved. Absent these steps/elements, it is unclear what processes are encompassed by “deactivating”. Regarding “deactivating” the specification teaches use of hydrogen peroxide and sodium hydroxide in the presence of white light (pages 26-27 and 33), which appears to read upon “fluorescent bleaching” recited in depending claim 18. However, depending Claims 4 and 5, which depend from Claim 1, recite different means for “deactivating” comprising contacting the cell or tissue sample with a nuclease selected from DNase or Nuclease P1. While claim limitations are to be read in light of the specification, it is improper to import steps/elements into the claim.
Claim 12 is indefinite wherein it recites a method comprising “using a machine learning algorithm.” MPEP 2173.05(q) states: “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). The case law applies to the instant claim because the claim similarly claims using an algorithm without setting forth those active steps delimiting how the algorithm is used to analyze the images.
Claim 16 is indefinite when read in light of the specification. Claim 16 recites a limitation “wherein the antibody is preconjugated with a fluorescent dye” that precedes the active steps of Claim 1. Increasingly the order of methods steps has been clarified in interference. The courts have held that the listing order is important and will be given limiting effect. Thus, in process/method claims, whenever possible claim steps should be written in the order in which they should be performed (See Mformation Tech v. Research-in-Motion, Fed. Cir. 2014 and Phillips v. AWH, Fed. Cir. 2005). The elements of a method claim are usually recited in temporal sequence, if one step modifies another, the modifying step should precede the modified step (Altiris, Inc. v. Symantec Corp. (2003)). Claims 16 modifies the method of Claim 1 but at the same time does not further limit the steps of the parent claim, rather it recites a step that temporally precedes those of the parent claim. For these reasons, the claims are indefinite when read in light of the specification.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 11-16, 18, 20 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming. Claim 1 recites, a first targeting moiety that interacts with a first specific protein of interest and a second targeting moiety that interacts with a second protein of interest in the cell or tissue sample. Claim 2 limits theses targeting moieties to a conjugate structure comprising an antibody and an oligonucleotide but fails to provide any specific structure for either the antibody or oligonucleotide. Claims 3-5, 11-16, 18, 20 and 22 are dependent from Claim 1, but do not further limit the “moiety”/”moieties” and do not require that the “moiety”/”moieties” possess any particular structure or other distinguishing feature. Therefore, the claims are drawn to a genus of moieties, antibodies and oligonucleotide.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see MPEP 2163(II)(3)(a)( i)(A), reduction to drawings MPEP 2163(II)(3)(a) (i)(B), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus MPEP 2163(II)(3)(a) (i)(C). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
In the instant case, the only factor present in the claim is a recitation of requisite activity (interacts with a protein of interest in the cell or tissue sample), but in the broadest sense, there is no identification of any particular portion of a structure that must be conserved for this requisite activity. Claim 2 recites: “each of the at least two targeting moieties comprises antibody and an oligonucleotide,” therefore this claim encompasses a genus of antibody/oligo conjugates.
Regarding the antibodies of the claims the specification lists 26 antibodies that were used – each of which appear to be commercially available before the time of filing (see paragraph [0091]). Regarding the oligonucleotide the specification teaches: “In some aspects, the oligonucleotide can be either covalently or non-covalently bound to the antibody. In some aspects, a part of a first oligonucleotide on the first targeting moiety is complementary to a part of a second oligonucleotide on the second targeting moiety. In some aspects, the first oligonucleotide is not complementary to the second oligonucleotide” (see [0047]). However, the oligonucleotides are not further described. Thus, the claims are drawn to a genus of antibody-oligo conjugates that is defined merely defined by function, and the instant specification fails to describe the genus encompassed by these claims.
Additionally, the specification fails to provide a representative number of species within the recited genus of antibody-oligo conjugates. Thus, in the absence of sufficient recitation of distinguishing identifying characteristics, or a representative number of species within the genus encompassed, the specification does not provide adequate written description of the claimed genus as to convey the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. § 112 is severable from its enablement provision (see page 1115).
Claims 1-5, 11-16, 18, 20 and 22 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 antibody-oligonucleotide conjugates that are listed in the specification (see Figures 4-9 and paragraph [0091]), does not reasonably provide enablement for the method wherein each of the at least two targeting moieties comprises any antibody and any oligonucleotide. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
In AMGEN INC. ET AL. v. SANOFI ET AL. (No. 21-757, decided May 18, 2023), the Supreme Court held that Amgen was not enabled for “the entire genus” of antibodies that (1) “bind to specific amino acid residues on PCSK9,” and (2) “block PCSK9 from binding to [LDL receptors]” (872 F. 3d 1367, 1372) even though Amgen identified the amino acid sequences of 26 antibodies that perform these two functions. The case law applies to the instant claims read upon an unlimited genus of “at least a first targeting moiety and a second targeting moiety, wherein the first targeting moiety interacts with a first specific protein of interest and the second targeting moiety interacts with a second protein of interest in the cell or tissue sample” or, in a preferred embodiment, an unlimited genus of antibody-oligonucleotide conjugates (claim 2), yet the inventors have disclosed at most only those that they have created and used (paragraph [0091] and Figures 4 through 9.
In Amgen, the Supreme Court has stated: “Despite recent advances, aspects of antibody science remain unpredictable. For example, scientists understand that changing even one amino acid in the sequence can alter an antibody’s structure and function. See id., at 14. But scientists cannot always accurately predict exactly how trading one amino acid for another will affect an antibody’s structure and function. Ibid.” This is applicable to the instant claims, because Applicant’s invention encompasses an unlimited array of targeting moieties, which in part comprise antibodies that have yet to be discovered, but the specification provides enabling guidance only for a finite list of antibodies that were commercially available at the time of filing.
Additionally, the claims recite very specific functional language (“wherein an interaction between the first specific protein of interest and the second specific protein of interest causes the first targeting moiety and second targeting moiety to be in close proximity to each other, wherein when the first targeting moiety and the second targeting moiety are in close proximity to each other, at least one detectable signal is produced”), without providing adequate enabling guidance as to how to make and use the genus of moieties encompassed by the claims. The following art demonstrating the current, post-filing (filing date 2022) state of the art and teaches much unpredictability remains with respect to making Antibody-Oligonucleotide conjugates (AOCs) (Jiao et al., Pharmacological Research 209 (2024) 107469). Jiao et al. state: “To maximize efficacy, AOCs should use antibodies targeting antigens with high tumor-specific expression, minimal shedding, and high affinity” (pg. 3, second column, second paragraph). Further, the reference states that linker structure is a key factor in AOC design, particularly where an interaction is required between the two (see pg. 6 at bullet 3.3). The reference states: “precise linker engineering is necessary to create functional and specific AOC constructs” (pg. 10, third paragraph). Lastly, whether AOCs are covalently bound or noncovalently bound also affects functionality and interaction (pg. 7 at bullets 3.3.1 and 3.3.2). The authors conclude: “limited quantitative methods exist to study the intra cellular release of oligonucleotides from AOCs and their subsequent interactions with cellular components, further constraining the rational design and optimization of AOCs” (pg.10 second to last paragraph). Thus, the repetitive step of contacting the tissue with different moieties in each round requires specific enabling guidance. The art teaches that, even within the current state of the art, AOCs “pose significant challenges in both their development and manufacturing processes” (pg. 10 second paragraph). The specification provides only enabling guidance for those specific constructs that were exemplified in Figures 4 through 9, the scope of which is much more narrow than the breadth of the claims.
Given that structure is essential to function, the unpredictability within the art with respect to creating AOCs, and the limited embodiments exemplified by the instant specification, the examiner concludes that a person having ordinary skill in the art would have to perform further experimentation in order to make a vast array of targeting moieties, or AOCs in particular, in order to demonstrate enablement with reasonable success commensurate in scope with the breadth of the claims. Given the nature of the invention, a skilled artisan would have to make multiple targeting moieties/AOCs, and then test their ability to interact with each other in close proximity to produce a detectable signal that is capable of being deactivated and repeated, in order to demonstrate use of the invention with a reasonable expectation of success. This amount of experimentation goes well-beyond what is considered “a reasonable degree of experimentation” and constitutes undue further experimentation in order to enable the method for the breadth of what is claimed.
For all of these reasons, the specification does not enable the claims, and Claims 1, 6, 9-11, and 13-21 are rejected under 35 U.S.C. 112(a).
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.
Claims 1-3, 11-16, 18, 20 and 22are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dovgan et al., Bioconjugate Chem. 2019, 30, 2483−2501.
While none of the instant claims read upon a method comprising a specific antibody as disclosed in paragraph [0091] of the instant specification, the Dovgan et al. prior art discloses AOCs that target EGFR (see Table 1, first column), which is listed in the specification (Id). As stated above, where Applicant has elected a grouping of species, Applicant acknowledges the grouping consists of “patentably indistinct species”. Therefore, the EGFR of the Dovgan reference is an obvious variants of the species listed in the instant disclosure at paragraph [0091]).
Regarding claims 1, 14, 20 and 22, Dovgan et al. disclose methods of detecting comprising: a) applying to the cell or tissue sample at least a first targeting moiety and a second targeting moiety, wherein the first targeting moiety interacts with a first specific protein of interest and the second targeting moiety interacts with a second protein of interest in the cell or tissue sample, wherein an interaction between the first specific protein of interest and the second specific protein of interest causes the first targeting moiety and second targeting moiety to be in close proximity to each other, wherein when the first targeting moiety and the second targeting moiety are in close proximity to each other, at least one detectable signal is produced. Specifically, Dovgan teaches Proximity ligation assays that utilize a pair of antibody-oligonucleotide conjugates (AOCs) with an affinity against different epitopes on the same protein or against different proteins (for protein−protein interaction studies). The oligonucleotide (ON) “fragments of the PLA probe are designed in such a way as to be complementary to a subsequently added connector ON. Then, only when two probes are brought into close proximity (that is, if the two original proteins of interest are in close proximity, or part of a protein complex, as shown in Figure 3a), the two ends can be joined together upon the addition of DNA ligases. The ligation products can then be replicated using PCR, while unreacted probes remain silent” (see paragraph bridging pgs. 2485-2486). This concept is illustrated in Figure 3 of the reference. Dovgan et al. state: “PLA was demonstrated to possess an exceptional sensitivity and was able to detect zeptomole amounts (40 × 10−21 mol) of targeted proteins. Given the large accessibility of antibodies and their exceptional targeting ability, the development of this approach was based on the use of such antibody−ON constructs. The prior art goes on to teach imaging the detectable signal or signals in the cell or tissue sample, wherein it discloses DNA-PAINT imaging. Specifically, Dovgan et al. teach: DNS-PAINT to be one of a family of “super-resolution microscopy techniques (also known as stochastic nanoscopy), which were developed to overcome the resolution limit of conventional light microscopy (defined by the wavelength of the light source used). The subfamily of these techniques that is used most often is based on the blinking of fluorophores (sequential activation), which permits them to be observed one at a time. This process of sparse activation is repeated until a sufficient number of position measurements is accumulated to allow the localization of the spatial coordinates of fluorophores with subdiffraction precision. DNA-PAINT achieves such “blinking” by the transient binding of dye-labeled imager DNA strands to their target complementary docking DNA strands immobilized on the object of interest” (see paragraph bridging pages 2486-87 and Figure 4b). Thus, the prior art teaches imaging as well as transient activation and deactivation of the detectable signal and repeating steps of instant claims 1 and 14; as well as the repeated at least three times of instant claim 20, wherein it states “repeated until a sufficient number of position measurements is accumulated to allow the localization of the spatial coordinates of fluorophores with subdiffraction precision” (pg. 2487, first paragraph). Thus, also teaching “subcellular spatial protein” imaging as recited by instant claim 22.
Regarding claims 2 and 15, Dovgan et al. disclose the two targeting moieties each comprises antibody and an oligonucleotide (a.k.a. antibody-oligonucleotide conjugates or AOCs of the reference). This also teaches the comprising an antibody of instant claim 15.
Regarding claim 3, Dovgan et al. teach methods comprising amplifying the oligonucleotides that are in close proximity to each other, wherein it teaches, “a significant in situ signal amplification could be achieved by means of a more elaborated ON design, in which the ON strain was used as a docking site for multiple fluorophore-bearing DNA imager strands, enabling controllable multiplexed signal amplification” (pg. 2488, first paragraph). Thus, the prior art discloses oligonucleotides are amplified as well as applying to the cell or tissue sample a fluorescent-labeled oligonucleotides (a.k.a. fluorophore-bearing DNA imager strands of the reference). The reference further states, “An important advancement in this field was the noncovalent transformation of the available DNA arrays into antibody arrays through hybridization with complementary AOCs” (pg. 2488, second paragraph), thus disclosing methods comprising an oligonucleotide that is complementary, as claimed.
Regarding claims 11 and 13, Dovgan et al. teaches methods comprising taking images of the cell or tissue sample at multiple spatial and/or temporal locations, wherein it discloses the DNA-PAINT “process of sparse activation is repeated until a sufficient number of position measurements is accumulated to allow the localization of the spatial coordinates of fluorophores with subdiffraction precision (pg. 2487, first paragraph). This teaches detection at the subcellular level as recited by instant claim 13.
Regarding claim 16, the Dovgan prior art teaches antibody conjugated with a fluorescent dye, wherein it discloses “[monoclonal antibody-oligonucleotide] mAb-ON conjugates further labeled with polyfluorophores for their application in cellular imaging” [g/ 2493, last paragraph).
Regarding claim 18, Dovgan disclose deactivating comprising fluorescent bleaching wherein it discloses, “DNA barcode AOCs conjugated via a photocleavable linker and their application for protein detection.” Specifically, the authors teach, “A photocleavable bifunctional maleimide-NHS cross-linker was used by the Weissleder group to generate a photocleavable DNA barcode−antibody conjugates for the improved detection of proteins in single live cells (Figure 9). Such a modification allowed for light-mediated DNA barcode release [a.k.a. ‘fluorescent bleaching’ of the claim], which enabled their isolation, amplification, and readout to be performed following target binding.” (see pg. 2491, second column, first full paragraph and Figure 9).
Therefore the invention of claims 1-3, 11-16, 18, 20 and 22 fail to distinguish over methods disclosed in the prior art, and the claims are rejected.
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.
Claims 1-5, 11-16, 18, 20 and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-14 of copending Application No. 18/456,768 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims within the reference application are drawn to a method of detecting analytes in a cell or tissue sample, the method comprising: a) introducing into the cell or tissue sample at least one tagging moiety, wherein the tagging moieties can interact with specific proteins of interest; b) detecting analytes and tagging moieties in the cell or tissue sample; c) spatially detecting proteins in the cell or tissue sample; and d) constructing a map of the analytes in the cell or tissue sample based on the data from steps b) and c). This is substantially similar to the instant methods comprising applying to the cell or tissue sample at least a first targeting moiety and a second targeting moiety, wherein the first targeting moiety interacts with a first specific protein of interest and the second targeting moiety interacts with a second protein of interest in the cell or tissue sample. Depending claims further recite spatially detecting proteins in the cell or tissue sample (instant claims 13 and 22). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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/STACEY N MACFARLANE/ Examiner, Art Unit 1675
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