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, filed 21 February 2025 in response to the restriction requirement mailed 23 December 2024, has been fully considered. As per Applicant’s election of Group II, claims 8-11 and 17-18 are pending under examination, wherein: claim 8 has been amended, claims 9, 11 and 17-18 are as previously presented, claim 10 is as originally filed, and claims 1-7 and 12-16 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 21 February 2025 is acknowledged.
Claims 1-7 and 12-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 21 February 2025.
Claim Objections
Claim 8 is objected to because of the following informalities: i) in step (3) “in absence” should instead be –in the absence--; ii) an –and-- is missing after the recitation of step (3); and iii) an –and-- is missing after the recitation of step (II). Appropriate correction is required.
Claim 9 is objected to because of the following informalities: i) in line 3 remove the comma after “C” and ii) in line 5 remove the comma after “that is”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: i) in line 1 remove the comma after “wherein” and ii) the compound recited contains a typo. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: i) in lines 1-2 “an amount” should instead be –the amount--; ii) “the acrylic acid” should instead be –the acrylic acid monomer-- remove the comma after “C”; ii) in line 5 remove the comma after “that is”; and iii) in line 3 “an amount” should instead be –the amount-- (note the 112(b) set forth below with respect to the sodium acrylate recitation). Appropriate correction is required.
Claim 18 is objected to because of the following informalities: in line 1 “an amount” should instead be –the amount--. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 8-11 and 17-18 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.
Regarding claim 8, the claim is indefinite and contains a plurality of issues of clarity such that the metes and bounds of what is being claimed cannot be readily determined.
With respect to the first recited (optional alternative) method of steps (1)-(4):
Firstly, regarding step (1): a) there is a lack of antecedent basis for “the magnetic microsphere body”; b) there is a lack of antecedent basis for “the outer surface”; and c) the recitation of “introducing amino groups…before forming a magnetic microsphere A” is indefinite as i) there is no clear recitation that magnetic microsphere A is obtained and ii) what must happen after the chemical modification to obtain said magnetic microsphere A (i.e. what results from step (1) is not clear). Additionally, the recitation of “in one of the preferred embodiments” renders the claim indefinite as a) it is unclear if said ‘preferred embodiment’ is merely exemplary and therefore not required (i.e. is optional) or is a required feature and b) it is not clear if the claim constitutes the ‘preferred embodiment’.
Secondly, regarding step (2): a) there is a lack of antecedent basis for “carboxyl” and it is not clearly set forth if the “carboxyl” refers to a carboxyl group of the acrylic acid molecule or is a further component; and b) the recitation of “by using a covalent reaction” is indefinite and it is not clear if the recitation intended to recite ‘performing’ a covalent reaction further ‘coupling…covalently…using a covalent reaction’ is redundant.
Thirdly, regarding step (3): a) the recitation of “polymerizing the acrylic monomer molecules by a polymerization reaction between the carbon-carbon double bond” is indefinite as i) step (2) recites a singular (‘an’) acrylic acid molecule which is what forms a carbon-carbon double bond and therefore the step (3) recitation of polymerizing plural acrylic acid molecules (where no further acrylic acid molecules are recited) is indefinite, and ii) the polymerization recitation is singular (the carbon-carbon bond) and it is not clear what is reacting (a reaction between the carbon-carbon double bond and what?); b) the recitation “having an obtained linear polymer covalently coupled” is indefinite as i) there is a lack of antecedent basis for ‘linear polymer’ and ii) the claim fails to clearly establish that the polymerization reaction results in a linear polymer; and c) the recitation of “before performing a solid-liquid separation” is indefinite and it is not clear if i) the claim intended to recite ‘followed by’ instead of ‘before performing’ , and ii) there is a lack of antecedent basis for any liquid phase and no reaction conditions are claimed that would establish the presence of a liquid phase; and d) it is not clear the difference between magnetic microsphere B and magnetic microsphere C, specifically step (2) recites the magnetic microsphere B is a magnetic microsphere having a carbon-carbon double bond but step (3) then recites the magnetic microsphere B is a magnetic microsphere having a linear polymer covalently attached, it is not clear if magnetic microsphere C is merely the isolated magnetic microsphere B of step (3) or is typographical error. Additionally, the recitation of “when the functional group contains the specific binding site” is indefinite as: i) there is a lack of antecedent basis for “the functional group” (what functional group?), ii) there is a lack of antecedent basis for ‘the specific binding site” (what specific binding site?), and iii) the use of “when” renders unclear if step (4) is merely exemplary and therefore not required (i.e. is optional) or is a required feature. Additionally, step (4) is indefinite as there is a lack of antecedent basis for ‘a branch chain’ as the claim recites no branched chains as present.
With respect to the second recited (optional alternative) method of steps (I), (II) and (4):
Firstly, with respect to step (I): a) as established above, there is a lack of antecedent basis for “the magnetic microsphere” and for “the outer surface”, which also applies here as this is a separate alternative method; b) the recitation of “by using” is indefinite and it is not clear if the claim intended to mean ‘by reacting with’ or similar; c) the recitation of “before forming a magnetic microsphere B” is indefinite as i) there is no clear recitation of what results from step (I) or what must happen after to obtain magnetic microsphere B (note that no magnetic microsphere A is recited in the second method recitation).
Furthermore with respect to step (I), a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, step (I) recites the broad recitation “a trimethoxysilanized acrylic molecule”, and the step (I) also recites γ-methacryloxy propyl trimethoxyl silane, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Secondly, with respect to step (II): a) it is not clear if “the acrylic monomer molecules” is further limiting to the “trimethoxysilanized acrylic molecule” of step (I) or is a recitation of an additional acrylic “monomer” molecule lacking proper antecedent basis with in the method; b) the recitation of “polymerizing the acrylic monomer molecules by a polymerization reaction between the carbon-carbon double bond” is indefinite as i) step (I) recites a singular (‘an’) acrylic molecule which is what forms a carbon-carbon double bond and therefore the step (II) recitation of polymerizing plural acrylic acid molecules (where no further acrylic acid molecules are recited) is indefinite, and ii) the polymerization recitation is singular (the carbon-carbon bond) and it is not clear what is reacting (a reaction between the carbon-carbon double bond and what?); c) the recitation “having an obtained linear polymer covalently coupled” is indefinite as i) there is a lack of antecedent basis for ‘linear polymer’ and ii) the claim fails to clearly establish that the polymerization reaction results in a linear polymer; and d) the recitation of “before performing a solid-liquid separation” is indefinite and it is not clear if i) the claim intended to recite ‘followed by’ instead of ‘before performing’, and ii) there is a lack of antecedent basis for any liquid phase and no reaction conditions are claimed that would establish the presence of a liquid phase; and e) it is not clear the difference between magnetic microsphere B and magnetic microsphere C, specifically step (I) recites the magnetic microsphere B is a magnetic microsphere having a carbon-carbon double bond but step (II) then recites the magnetic microsphere B is a magnetic microsphere having a linear polymer covalently attached, it is not clear if magnetic microsphere C is merely the isolated magnetic microsphere B of step (II) or is typographical error. Additionally, the recitation of “when the functional group contains the specific binding site” is indefinite as: i) there is a lack of antecedent basis for “the functional group” (what functional group?), ii) there is a lack of antecedent basis for ‘the specific binding site” (what specific binding site?), and iii) the use of “when” renders unclear if step (4) is merely exemplary and therefore not required (i.e. is optional) or is a required feature. Additionally, step (4) is indefinite as there is a lack of antecedent basis for ‘a branch chain’ as the claim recites no branched chains as present.
Finally, claim 8 is directed, as per the preamble, to a preparation method for “a biomagnetic microsphere” however, at no point do either of the two optional/alternative preparation methods recite that a biomagnetic microsphere is obtained/produced. At best the claim results in a “magnetic microsphere C” that optionally further contains a functional group with a specific binding site (unspecified). It is therefore unclear what is being claimed and what is intended to result from the claimed method(s). This includes claims 9-11 and 17-18 as they depend from claim 8.
Regarding claim 9, the claim is indefinite as it recites a step (4) where claim 8 already recites two step (4) and the difference is not clear, nor is it clear if the step (4) of claim 9 is intending to be further limiting to the step (4)s of claim 8 or how it further limits. There is a lack of antecedent basis for i) tricarboxylic amine, ii) for Ni2+, and iii) for “the His tag”. The recitation of “before” is indefinite and it is not clear if the claim intended to recite’ ‘followed by complexing’. Additionally, the recitation that “magnetic microsphere D” is the ”target biomagnetic microsphere” further renders the claim indefinite and appears to establish that independent claim 8 does not result in the claimed biomagnetic microsphere of its preamble, as additional steps are required. It is also not clear if by “able to bind to a label of the His tag specifically” was intended to recite ‘able to bind to a label of the His tag with specificity’ or is merely a property recitation (as in, is capable of binding to His). This includes claims 10 and 18 as they depend from claim 9.
Regarding claim 11, there is a lack of antecedent basis for “the sodium acrylate” and it is further noted that step (3) contains no recitation differentiating the acrylic acid monomers of step (2) from those of step (3).
Regarding claim 17, it is not clear which acrylic monomer molecule of claim 8 is being referred to and/or further limited as two preparation methods are recited which contain plural recitations of acrylic molecules.
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 8 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-15 of copending Application No. 17/781,025 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of both the instant and copending applications are directed to substantially similar methods of obtaining a biomagnetic microsphere comprising substantially similar steps, components, conditions, etc.
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 JANE L STANLEY whose telephone number is (571)270-3870. The examiner can normally be reached M-F 7:30 AM to 3:30 PM.
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/JANE L STANLEY/Primary Examiner, Art Unit 1767
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