DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-19 and species (1) (each amplicon cluster comprises an amplification product formed via a rolling-circle amplification reaction, see claim 3) in the reply filed on May 27, 2026 is acknowledged. Claims 1-13 and 16-19 will be examined.
Specification
The disclosure is objected to because of the following informalities: since case 18/988,274 has been patented, applicant is required to update this information in paragraph [0001] of the specification.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informality: “a plurality of focal planes” should be “other focal planes of the composition”.
Claim 3 or 4 is objected to because of the following informality: “each amplicon cluster” should be “each of the amplicon clusters”.
Claim 7 is objected to because of the following informality: “the first focal plane and the second focal plane are each xy planes” should be “each of the first focal plane and the second focal plane is a xy plane”.
Claim 8 is objected to because of the following informality: “detecting further comprises forming a two-dimensional image at each focal plane” and “step (a) further comprises forming a two-dimensional image at the first focal plane and step (b) further comprises forming a two-dimensional image at the second focal plane”.
Claim 10 is objected to because of the following informality: “wherein detecting” should be “further”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 1-10, 13, and 16-19 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.
Applicant is referred to the interim guidelines on written description published on December 21, 1999 in the Federal Register at Volume 64, Number 244, pp.71427-71440.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111 (Fed. Cir. 1991), clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” Vas-Cath Inc. v. Mahurkar, 19USPQ2d at 1117. The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed”. Vas-Cath Inc. v. Mahurkar, 19USPQ2d at 1116.
The specification provides adequate written description for an artificial composition comprising a plurality of cores surrounded by a shell polymer wherein each core of the plurality of cores is surrounded by a shell polymer and the core is formed by polymerized units of core monomers forming a core polymer or an artificial composition comprising a three-dimensional polymer matrix (see paragraphs [0005] and [0126] of US 2026/0085350 A1, which is US publication of this instant case). However, the specification fails to adequately describe any kind of composition comprising a first focal plane and a second focal plane as recited in claims 1-10, 13, and 16-19. The claimed inventions as a whole are not adequately described if the claims require essential or critical elements which are not adequately described in the specification and which are not conventional in the art as of Applicants effective filing date. Possession may be shown by actual reduction to practice, clear depiction of the invention in a detailed drawing, or by describing the invention with sufficient relevant identifying characteristics (as it relates to the claimed inventions as a whole) such that a person skilled in the art would recognize that the inventor had possession of the claimed invention. Pfaff v. Wells Electronics, Inc., 48 USPQ2d 1641, 1646 (1998).
In this instant case, the composition recited in claims 1-10, 13, and 16-19 is read as any kind of composition comprising a first focal plane and a second focal plane. Since there is no definition for “focal plane” in the specification and it is known that “focal plane” in the art is defined as “plane in object space where a point source will form an in-focus image on the image plane, given a particular di. Though sometimes called the ‘object plane’ or the ‘specimen plane,’ it is more appropriately called the focal plane because it is the locus of all points that the optical system can image in focus” (see the definition for “focal plane”) and a composition in biology
refers to “the chemical makeup of living organisms at various levels of organization and includes the composition of cells, tissues, organs, and organ systems” (see the definition for “Composition In Biology”), a cell or a tissue or an organ can have a first focal plane and a second focal plane and can be reasonably considered as a composition comprising a first focal plane and a second focal plane as recited in claims 1-10, 13, and 16-19. However, nowhere in the specification describes that a cell or a tissue or an organ is a composition comprising a first focal plane and a second focal plane as recited in claims 1-10, 13, and 16-19. Therefore, claims 1-10, 13, and 16-19 encompass numerous unknown and unidentified compositions comprising a first focal plane and a second focal plane that miss from the disclosure. Therefore, the general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed.
With limited disclosure provided by the specification, the skilled artisan cannot envision all unknown and unidentified compositions comprising a first focal plane and a second focal plane recited in claims 1-10, 13, and 16-19 and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method used. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of identifying it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991).
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481, 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Enablement
Claims 1-13 and 16-19 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) the court considered the issue of enablement in molecular biology. The Court summarized eight factors to
be considered in a determination of “undue experimentation”. These factors include: (a) the quantity of experimentation necessary; (b) the amount of direction or guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the relative skill of those in the art; (g) the predictability of the art; and (h) the breadth of the claims. The Court also stated that although the level of skill in molecular biology is high, results of experiments in molecular biology are unpredictable.
To begin, there is no direction or guidance to show that amplicon clusters within a composition disposed within a channel of a flow cell can be detected using the methods recited in claims 1-13 and 16-19. While the relative skill in the art is very high (the Ph.D. degree with laboratory experience), there is no predictability whether amplicon clusters within a composition disposed within a channel of a flow cell can be detected using the methods recited in claims 1-13 and 16-19.
Since the specification teaches that each of the amplicon clusters comprises an amplification product formed via a rolling-circle amplification reaction, “[I]n embodiments of the methods provided herein, the amplifying step further includes contacting the plurality of cores with one or more reagents for amplifying the target polynucleotide. Examples of reagents include but are not limited to polymerase, buffer, and nucleotides (e.g., a sequencing reaction mixture). In embodiments, the nucleotides are reversibly-terminated nucleotides carrying
fluorescent dyes” and [I]n embodiments of the methods provided herein, the detecting step includes imaging through each of the multiple two-dimensional planes at a resolution sufficient to distinguish one imaged plane from an adjacent imaged plane. In embodiments of the methods provided herein, the detecting step includes imaging through each of the multiple two-dimensional planes at a resolution sufficient to distinguish one particle from an adjacent particle. In embodiments of the methods provided herein, the detecting step includes imaging through each of the multiple two-dimensional planes at a resolution sufficient to distinguish one particle from another vertically adjacent particle. In embodiments, overlap of a signal of a core in one layer appearing in adjacent layer, is computationally resolved, for example, by imaging software. In embodiments of the methods provided herein, the imaging is accomplished by confocal microscopy, multi-photon microscopy, or light sheet fluorescence microscopy (LSFM). In embodiments, the imaging is accomplished by confocal microscopy. In embodiments, the imaging is accomplished by multi-photon microscopy (e.g., two-photon excited fluorescence or two-photon-pumped microscopy). Unlike conventional single-photon emission, multi-photon microscopy can utilize much longer excitation wavelength up to the red or near-infrared spectral region. This lower energy excitation requirement enables the implementation of semiconductor diode lasers as pump sources to significantly enhance the photostability of materials. In embodiments, the imaging is accomplished by LSFM (claim 3 and paragraphs [0166] and [0171] of US 2026/0085350 A1, which is US publication of this instant case), the specification clearly indicates that amplicon clusters must be labeled with fluorescent dyes before they are detected. Since claim 1 does not require that amplicon clusters are labeled with fluorescent dyes, if the amplicon clusters are not labeled with fluorescent dyes, it is unpredictable how fluorescent emissions from the amplicon clusters at a first focal plane of the composition can be detected,
how fluorescent emissions from the amplicon clusters at a second focal plane of the composition can be detected, and how fluorescent emissions from the amplicon clusters at a plurality of focal planes of the composition can be detected by repeating (a) and (b) of claim 1 such that amplicon clusters within a composition disposed within a channel of a flow cell cannot be detected using the methods recited in claims 1-13 and 16-19. Furthermore, as mentioned in above written description rejection, the composition recited in claims 1-10, 13, and 16-19 is read as any kind of composition comprising a first focal plane and a second focal plane. Since there is no definition for “focal plane” in the specification and it is known that “focal plane” in the art is defined as “plane in object space where a point source will form an in-focus image on the image plane, given a particular di. Though sometimes called the ‘object plane’ or the ‘specimen plane,’ it is more appropriately called the focal plane because it is the locus of all points that the optical system can image in focus” (see the definition for “focal plane”) and a composition in biology
refers to “the chemical makeup of living organisms at various levels of organization and includes the composition of cells, tissues, organs, and organ systems” (see the definition for “Composition In Biology”), a cell or a tissue or an organ can have a first focal plane and a second focal plane and can be reasonably considered as a composition comprising a first focal plane and a second focal plane as recited in claims 1-10, 13, and 16-19. However, nowhere in the specification describes that a cell or a tissue or an organ is a composition comprising a first focal plane and a second focal plane as recited in claims 1-10, 13, and 16-19. Therefore, claims 1-10, 13, and 16-19 encompass numerous unknown and unidentified compositions comprising a first focal plane and a second focal plane that miss from the disclosure. Without knowing these numerous unknown and unidentified compositions comprising a first focal plane and a second focal plane, the skilled artisan does not know whether fluorescent emissions from the amplicon clusters can be detected a first focal plane and a second focal plane of any kind of composition such as a whole organ (ie., a heart) wherein the amplicon clusters is located inside of the whole organ.
Case law has established that “(t)o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright 990 F.2d 1557, 1561. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) it was determined that “[T]he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art”. The amount of guidance needed to enable the invention is related to the amount of knowledge in the art as well as the predictability in the art. Furthermore, the Court in Genentech Inc. v Novo Nordisk 42 USPQ2d 1001 held that “[I]t is the specification, not the knowledge of one skilled in the art that must supply the novel aspects of the invention in order to constitute adequate enablement”.
In view of above discussions, the skilled artisan will have no way to predict the experimental results. Accordingly, it is concluded that undue experimentation is required to make the invention as it is claimed. The undue experimentation at least includes to test whether amplicon clusters within a composition disposed within a channel of a flow cell can be detected using the methods recited in claims 1-13 and 16-19.
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.
Claim 7 is 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 7 is rejected as vague and indefinite. Since claims 1 and 7 does not require that the composition is a three-dimensional composition, it is unclear why the first focal plane and the second focal plane can be xy planes acquired by scanning along a z-axis of the composition as recited in claim 7. Please clarify.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Frank Lu, Ph. D., whose telephone number is (571)272-0746. The examiner can normally be reached Monday to Friday, 9 AM to 5 PM.
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/FRANK W LU/
Primary Examiner, Art Unit 1683
June 26, 2026
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