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 with respect to Groups I, II, and III, in the reply filed on 6/15/2026 is acknowledged. The traversal is on the ground(s) that:
For the restriction between Group I and Group II, the two-way distinctiveness test for a combination and subcombination is not met; and there is no separate classification to search.
For the restriction between Group I and Group III, the Office has not shown a two-way distinctiveness exists between Group I and Group III; the Office has not shown the restriction is necessary due to separate classifications.
These arguments are found persuasive for the following reasons:
The inventions of Group I and Group II are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed are of materially different design. Group II requires a nucleic acid, which is not required by Group I. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Applicant argues that a two-way test for combination and subcombination is required. However, even if this were true, Examiner notes that Group I and Group II are directed to related products, not combination/subcombination, and therefore, the Applicant’s argument is irrelevant. Regardless, in the instant case, the inventions as claimed are distinct because they are of materially different design. For example, Group I is drawn to a transfection reagent, while Group II is drawn to a transfection reagent and a nucleic acid. These different types of products are unlikely to have the same design, function, or effect. Thus, each product will have materially different results. Consequently, the related inventions are distinct, i.e. mutually exclusive, and the art anticipating or rendering obvious each of the above-identified groups would not necessarily anticipate or render obvious another group, because they are drawn to different inventions that have different distinguishing mode of operations, functions, and/or results.
The inventions of Group I and Group III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, Invention I can be used in a materially different process, such as in toxicology screenings. Invention III could be practiced with compounds materially different than Invention I, such as a myriad of cationic polymers.
Applicant argues that “the Office has not shown that two-way distinctiveness exists between the claims of Groups I and III” (Remarks filed 6/15/2026, page 4). Two-way distinctness is only required when inventions are in the same statutory category, while one-way distinctness is sufficient when inventions are in different statutory categories. The inventions of Group I and Group III belong to a different statutory category, and thus, two-way distinctness is not required.
Regarding Applicant’s general argument that there is no separate classification to search: while the distinct inventions may share overlapping classifications, a different field of search would still be required by the Examiner. It is not the same search.
The requirement is still deemed proper and is therefore made FINAL.
Applicant has elected the following species:
PNG
media_image1.png
125
592
media_image1.png
Greyscale
Applicant asserts that claims 5-6, 9-12, and 15-18 read upon the provisionally elected species. Therefore, claims 5-23 are pending and claims 5-6, 9-12, and 15-18 presently under examination. Claims 7-8, 13-14, and 19-23 are withdrawn based on the species election and restriction requirement.
Priority
The instant application is a continuation application of U.S. Application No. 16/797,967, filed February 21, 2020, now U.S. Patent No. 11,739,174, which is a continuation application of U.S. Application No. 14/632,385, filed February 26, 2015, now U.S. Patent No. 10,619,162.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 10/19/2023 is in compliance with the provisions of 37 CFR 1.97. All references have been considered except where marked with a strikethrough. A signed copy of Form 1449 is included with this Office Action.
Specification
The specification is objected to because: in the specification filed 10/13/2023, which cross-references to related applications, Applicant asserts that the instant application is, “a continuation application of U.S. Application No. 14/632,385, filed February 26, 2013, now U.S. Patent No., 10,619,162.” (emphasis added). However, U.S. Application No. 14/632,385 was actually filed February 26, 2015. Examiner requests amending the specification to properly claim priority and priority date.
Acknowledgement is made of the drawings received 10/13/2023.
The drawings are objected to because:
In FIG. 3, the quality of the text (for instance, above and below the reaction arrow) is poor and it is difficult to determine the reaction conditions. (Also: in the definition of x, there is an open-ended parenthesis in, “…where x = 0 – 6)” that needs to be removed. As recited in 37 CFR 1.84:
(l) Character of lines, numbers, and letters. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Lines and strokes of different thicknesses may be used in the same drawing where different thicknesses have a different meaning.
In FIG. 5, the variable ‘n’ is present in the reaction scheme but undefined.
In FIG. 9, the variables R, R1, R2, R3, and R4 are present in the diagrammed compounds but undefined.
In FIG. 10, the variables R and R1 are present in the diagrammed compounds but undefined.
In FIG. 11, it is unclear why there are parentheses in the compounds labeled “3103” and “3301” if there aren’t repeating units.
In FIG. 13, the variable ‘k’ is present in the diagrammed compounds but undefined.
FIG. 1 – FIG. 8 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 5-6, 9 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.
Claim 5-6, and 9 are rejected as vague and indefinite for its recitation of the term “lipid group” in the limitation of R1 and R2. The specification does not disclose any definition of a “lipid group”, and therefore, it is unclear what the metes and bounds are of the term “lipid group”. Fahy et al. writes (page 637, Introduction), “The diversity in lipid function is reflected by an enormous variation in the structures of lipid molecules” and further writes (page 637, Lipid classification and nomenclature):
The term “lipid” has been loosely defined as any of a group of organic compounds that are insoluble in water but soluble in organic solvents. These chemical features are present in a broad range of molecules such as fatty acids, phospholipids, sterols, sphingolipids, terpenes and others. In view of the fact that lipids comprise an extremely heterogeneous collection of molecules from a structural and functional standpoint, it is not surprising that there are significant differences with regard to the scope and organization of current classification schemes. (emphasis added)
Fahy clearly explains that the term “lipid” is only loosely defined, are present in a broad range of molecules, and comprises an extremely heterogenous collection of molecules from a structural and functional standpoint. The specification does not aid in interpreting the metes and bounds of the term “lipid group”, and the scope of the claims is broader than the specification enabling disclosure. As a result, one of skill in the art would not be able to determine the metes and bounds of the claimed subject matter.
Claims 5, 8, 10 and 18 are rejected for reciting “comprising” or “comprises”. Claims drawn to a Markush grouping of alternatively usable members requires selection from a closed group “consisting of” the alternative members. Claims 5, 8, 10 and 18 are currently indefinite because it is unclear what other alternatives are intended to be encompassed by the claim because the Markush grouping is written in an open list of alternatives. See In re Kiely, 2022 USPQ2d 532. Relevant guidance can be found in the MPEP 2117.I, and MPEP § 2173.05(h), titled “Alternative Limitations,” which deals with claims that list alternatives.
Claim 5 is rejected to as vague because it recites, in the limitation of R3 and R4, the following structure, where the nitrogen atom of the pyridine, circled, exceeds its valency.
PNG
media_image2.png
97
126
media_image2.png
Greyscale
Does the Applicant intend for the nitrogen to be positively charged, or did the Applicant actually intend for the atom to be carbon, instead? Appropriate correction is required.
Claim 17 recites the limitation "said linear C10-C20 alkenyl, or said branched C10-C20 alkenyl” in the definition of R1 and R2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 112(a)
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.
Claim 5 is 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.
This is a written description rejection.
The analysis for adequate written description considers the following:
(a) Actual reduction to practice;
(b) Disclosure of drawings or structural chemical formulas;
(c) Sufficient relevant identifying characteristics, such as (i) complete/partial structure, (ii) physical and/or chemical properties, and (iii) functional characteristics when coupled with known or disclosed correlation with structure; and
(d) Representative number of samples.
A lack of adequate written description issue arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571,39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
In particular, the specification as originally filed fails to provide sufficient written description on the bases of any of the agents demonstrating wherein possession of use of the broad term: lipid group. The specification fails to provide any definition for the term “lipid” or “lipid group”. The mere fact that Applicant may have discovered one specific type of lipid group usable in their invention of a transfection reagent of claim 5 is not sufficient to claim the entire genus. The claims lack written description because the genus of lipid group has substantial variance while the specification lacks sufficient variety of species to reflect the variance within the genus, and because of the lack of common structural attributes of the claimed genus, combined with a correlation between structure and function. The specification does not tell one of ordinary skill what variation is permitted by “lipid group” and the different types of lipid groups are not be expected to act similarly.
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, reduction to drawings, 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. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]."
Thus, said claim is rejected under 35 USC 112(a), (Written Description).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 5-6, 9-12, 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wolff et al. (US Patent 5,744,335, published April 28, 1998)(hereinafter, ‘Wolff’).
Wolff discloses (col 10, lines 45-55) the following structure, Compound #4:
PNG
media_image3.png
148
397
media_image3.png
Greyscale
Compound #4 reads on instantly claimed genus, where n = 0; m = 3; R3, R4 = H; R1, R2 are a lipid group (here, linear C18 alkenyl group). Regarding instant claim 11, which specify a cis- double bond geometry, Wolff discloses (col 10, lines 60-67) in the synthesis of Compound #4 that, “1,4-Bis(3-Aminopropyl)piperazine was dissolved in 5 ml of dioxane and mixed with 722 mg (2.2 mmol) of oleoyl chloride” (emphasis added). Oleoyl chloride is a known chemical compound already having cis- double bond geometry.
Wolff also teaches the compound generically (col 28, claim 7, lines 52-65), where R is a “hydrophobic moiety selected from the group consisting of C6-C24 alkane, C6-C24 alkene, sterol, lipid, and hydrophobic hormone”.
PNG
media_image4.png
214
297
media_image4.png
Greyscale
Thus, each and every required element of said claims is taught by the prior art and the claims are anticipated.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5-6, 9-12, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wolff.
The previous 102(a)(1) rejection as anticipated by Wolff is incorporated herein.
As described in the 102(a)(1) rejection disclosed by Wolff, Wolff discloses Compound 4:
PNG
media_image3.png
148
397
media_image3.png
Greyscale
Regarding claim 17: The instant application requires that m = 4, while the reference application discloses m = 3.
The Court of Customs and Patent Appeals (CCPA) has defined a homologous series as a family of chemically related compounds, the composition of which varies from member to member by a -CH2 (one atom of carbon and two hydrogen). In re Coes, Jr. (CCPA 1949) 173 F2d 1012, 81 USPQ 369. The Court of Appeals for the District of Columbia applied a broader definition and defined a homolog (homologue) as a member of a series of compounds in which each member differs from the next member by a constant number of atoms. Carr. Pats.v. Deutsche Gold-und-Sllber, etc. (CADC 1968) 397 F2d 656,157 USPQ 549.
The "Hass-Henze Doctrine" evolved from three CCPA cases, viz., In re Hass et al. (CCPA 1944) 141 F2d 122 and 127, 60 USPQ 544 and 548; and In re Henze (CCPA 1950) 181 F2d 198, 85 USPQ 261. In the Henze decision, the Court said:
"The nature of homologues and the close relationship the physical and chemical properties of one member of a series bears to adjacent members is such that a presumption of unpatentability arises against a claim directed to a composition of matter, the adjacent homologue of which is old in the art. The burden is on the applicant to rebut that presumption by a showing that the claimed compound possesses unobvious or unexpected beneficial properties not actually possessed by the prior art homologue. It is immaterial that the prior art homologue may not be recognized or known to be useful for the same purpose or to possess the same properties as the claimed compound. The CCPA concluded that because the characteristics normally possessed by members of a homologous series are principally the same, varying gradually from member to member, chemists knowing the properties of one member of a series would in general know what to expect in adjacent members so that a mere difference in degree is not the marked superiority which will ordinarily remove the unpatentability of adjacent homologues of old substances. Contra, where no use for the prior art compound is known. In re Stemniski (CCPA 1971) 444 F2d 581, 170 USPQ 343, and cases cited therein. Whether a compound is patentable over a prior art homologue or isomer is a question to be decided in each case. In re Hass et al., supra."
The 'Hass-Henze Doctrine" stands for the proposition that, "If that which appears at first blush to be obvious though new is shown by evidence not to be obvious then the evidence prevails over surmise or unsupported contention and rejection based on obviousness must fail." In re Papesch (CCPA 1963) 315 F2d 381, 137 USPQ 43, 48. The presumption that homologues are unpatentably obvious is an inference of fact, viz., that adjacent homologs are expected to have similar properties which places a 'burden of persuasion' on the applicant who asserted a contrary fact. In re Mills (CCPA 1960) 281 F2d 218, 126 USPQ 513.
Compounds that differ only by the presence of an extra methyl group are homologs. Homologs are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homolog. The homolog is expected to be capable of preparation by the same method and to have the same properties. This expectation is then deemed the motivation for preparing homologs. Homologs are obvious even in the absence of a specific teaching to methylate, In re Wood 199 USPQ 137; In re Hoke 195 USPQ 148; In re Lohr 137 USPQ 548; In re Magerlein 202 USPQ 473; In re Wiechert 152 USPQ 249; Ex parte Henkel 130 USPQ 474; In re Fauque 121 USPQ 425; In re Druey 138 USPQ 39. In all of these cases, the close structural similarity of two compounds differing by only one (or two) methyl groups sufficed; no specific teaching to methylate was present or required. None of these cases has been overruled and indeed the examiner is unaware of any post-Lohr case in which motivation is required to put a methyl group on an old compound.
Given the small structural difference, the compounds of instant claims may only be regarded as nonobvious if the compounds of instant claim 17 present unexpected effects of properties in relation to the compounds disclosed by Wolff. No such effects or properties are indicated or supported in the instant application. Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill to take known reference compounds of Wolff and make a structural methylene homolog to arrive at compounds of instant genus of claim 17 with a reasonable expectation of success.
Thus, said claims are rendered obvious.
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 5, 15, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 9 and 14 of U.S. Patent No. 11,739,174 B2 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims 1, 2, and 14 are drawn to a composition comprising a polymer of a first cyclic amine and an amphipathic compound comprising a second cyclic amine, wherein (reference claim 2) said first cyclic amine comprises two or more carbons and at least one secondary or tertiary amine, and wherein (reference claim 14) said cyclic amine comprises a structure of:
PNG
media_image5.png
75
102
media_image5.png
Greyscale
Meanwhile, instant claim 5 is drawn to an amphipathic compound comprising the same diazepine above, and a first cyclic amine, which can be selected from a variety of cyclic amines listed in the limitations of R3 and R4 in instant claim 5 (see below):
PNG
media_image6.png
80
368
media_image6.png
Greyscale
PNG
media_image7.png
99
285
media_image7.png
Greyscale
In these instances, the reference patent and instant applications are not patentably distinct.
Claims 5-6, 9-12, and 15-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,619,162 B1 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 1 is drawn to a transfection reagent comprising: a transfection complex consisting of a cationic cyclic amine and a nucleic acid. Instant claims 5-6, 9-12, and 15-18 are also drawn to a transfection reagent that is a cationic cyclic amine. Reference claim 1 is drawn to a composition that is more specific than the composition of instant claims 5-6, 9-12, and 15-18, in that reference claim 1 additionally recites a nucleic acid. Therefore, reference claim 1 of ‘162 is a “species” of the generic invention of application claims 5-6, 9-12, and 15-18. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claims 5-6, 9-11, and 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6 of U.S. Patent No. 9,290,779 B1 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 1 is drawn to a transfection reagent comprising a amphipathic compound containing an imidazole and a cationic polymer, wherein the amphipathic compound has the structure comprising:
PNG
media_image8.png
106
357
media_image8.png
Greyscale
,
wherein R1-R4 are selected from the group consisting of alkene and substituent comprising imidazole, wherein at least one of R1-R4 is a substituent comprising imidazole.
Instant claim 5 is drawn to an amphipathic compound that is patentably indistinct from reference application when, in instant claim 5: m =3, n = 0, R1 and R2 are a lipid group (here, an alkene), and R3 and R4 are selected from any of the imidazoles of instant claim 5, shown below:
PNG
media_image9.png
114
288
media_image9.png
Greyscale
PNG
media_image10.png
65
186
media_image10.png
Greyscale
PNG
media_image11.png
95
191
media_image11.png
Greyscale
PNG
media_image12.png
84
105
media_image12.png
Greyscale
In these instances, the reference patent and instant applications are not patentably distinct.
Claims 5-6, 9-11, and 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 8,921,448 B1 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims 1-2 are drawn to a transfection composition comprising: a amphipathic compound containing an imidazole and a cationic polymer, wherein the amphipathic compound has the structure comprising:
PNG
media_image13.png
172
338
media_image13.png
Greyscale
,
wherein R1 and R2 are selected from the group consisting of an alkene and an imidazole.
Instant claim 5 is drawn to an amphipathic compound that is patentably indistinct from reference application when, in instant claim 5: m =3, n = 0, R1 and R2 are a lipid group (here, an alkene), and R3 and R4 are selected from any of the imidazoles of instant claim 5, shown below:
PNG
media_image9.png
114
288
media_image9.png
Greyscale
PNG
media_image10.png
65
186
media_image10.png
Greyscale
PNG
media_image11.png
95
191
media_image11.png
Greyscale
PNG
media_image12.png
84
105
media_image12.png
Greyscale
In these instances, the reference patent and instant applications are not patentably distinct.
Claims 5-6, 9-12, and 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 7,101,995 B1 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
The amphipathic compound of reference claims 1-4 has the structure comprising:
PNG
media_image14.png
162
335
media_image14.png
Greyscale
,
wherein R1 and R2 are selected from the group consisting of C6-C24 alkene.
Instant claim 5 is drawn to an amphipathic compound that is patentably indistinct from reference application when, in instant claim 5: m =3, n = 0, R3 and R4 = H, R1 and R2 are a lipid group (here, an alkene). In these instances, the reference patent and instant applications are not patentably distinct.
Reference claim 1 is drawn to a composition comprising: an amphipathic compound, a ethoxylated polyethyleneimine, and a siRNA. Instant claims 5-6, 9-12, and 15-18 are also drawn to a transfection reagent that is a cationic cyclic amine. Reference claim 1 is drawn to a composition that is more specific than the composition of instant claims 5-6, 9-12, and 15-18, in that reference claim 1 additionally recites an ethoxylated polyethyleneimine and a siRNA. Therefore, reference claim 1 of ‘995 is a “species” of the generic invention of application claims 5-6, 9-12, and 15-18. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Conclusion
All claims are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUKE ALAN BORALSKY whose telephone number is (571)272-9746. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 am.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.A.B./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
Prosecution Insights