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’s reply and amendment filed 2/3/2026, are acknowledged. Claims 16-18 and 20-37 are pending. Claims 16-18, 22, 27, 28, 31 and 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/23/2025.
Response to Amendment
Applicant’s arguments with respect to claim(s) 20, 21, 23-26, 29-30, 32 and 36-37 have been considered but are moot because the claims, as amended, are directed to a method for obtaining an altered and disturbed particle. The rejection of 11/05/2025, has been withdrawn.
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 20, 21, 23-26, 29-30, 32-33 and 35-37 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.
Claims 20 and 21 are rejected for being prolix. Examiners should reject claims as prolix only when they contain such long recitations or unimportant details that the scope of the claimed invention is rendered indefinite thereby. Claims are rejected as prolix when they contain long recitations that the metes and bounds of the claimed subject matter cannot be determined. In this instance, claim 20 runs four (4) pages long and claim 21 runs three (3) page long.
Since claims 23-26, 29-30, 32 and 36-37 depend from claim 20 they are indefinite. Further, given the prolixity of claims 20 and 21, (as well as in other dependent claims (e.g., claims 24, 25, 29 and 30), a reasonable comprehensive search inquiry and consideration of the prior art for all the limitations cannot be performed.
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.
Claims 20, 21, 23-26, 29-30, 32-33 and 35-37 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.
Prolixity notwithstanding, claims 20 and 21 may be distilled to a method for obtaining an altered and disturbed particle comprising one step, i.e., applying an alteration on at least one initial particle comprising at least one initial nanoparticle and at least one releasable initial compound bound to the nanoparticle via an initial bond. Just this simple characterization provides an example as to why the specification fails to describe the invention. Here, the terms “compound,” “nanoparticle” and “particle” are generic terms. Additionally, the terms “altered,” “alteration,” “disturbed,” and “disturbance” are vague and indefinite. For instance, in claim 20 it is unclear whether “applying an alteration” defines a change in physical structure or defines a process or phase such that the term “altered” when used with nanoparticle or compound simply indicates that such components have gone through a process or phase regardless of physical change, if any. For example, if heat were applied to a component, but no physical change of the component results, would “altered component” read on the unchanged component? Further, what if the term “altered” defines a physical description/result? Is the change the same for a nanoparticle and compound or could the changes be different? Indeed, terms in a claim should be given consistent meaning, but it is not clear from the claim or the specification that the alteration is the same for the nanoparticle or the compound.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. Indeed, it has been held that “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification . . . demonstrates that the applicant has invented species sufficient to support a claim to a genus” with such breadth. Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2D 1161, 1171 (Fed. Cir. 2010).
To be clear, the factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, and any combination thereof. However, “[a] patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).
Here, the specification provides only examples with respect to magnetosomes. There does not appear to be an adequate written description in the specification, as filed, of a genus of increasing the releasing of any type of “compound” bound to any type of “nanoparticle” to form any type of “particle.” There are many more generic terms presented in the pages of claims 20 and 21, which further exemplify the claims’ lack of written description. For example, “a cell, part of a cell, a virus, part of virus, a bacterium, [etc.]”
Although the specification may read as a laundry list of possible materials and/or conditions that would fall within the limitations of the claims, the description requirement of the patent statute requires a description of an actual invention, not merely an indication of a result that one might achieve if one made that invention. See, e.g., In re Wilder, 22 USPQ 369, 372-3 (Fed. Cir. 1984) (holding that a claim was not adequately described because the specification did ‘little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate’).
Accordingly, one of ordinary skill in the art would not reasonably recognize that the claim breadth was actually in the applicants’ possession as of the filing date. “Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others. ‘[A] patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.’” Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2D 1161, 1173-74 (Fed. Cir. 2010), quoting University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 930 (Fed. Cir. 2004). Requiring a written description of the invention limits patent protection to those who actually perform the difficult work of “invention” – that is, conceive of the complete and final invention with all its claimed limitations – and disclose the fruits of that effort to the public.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT S CABRAL/Primary Examiner, Art Unit 1614
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