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 .
Detailed Action
This application is a national stage application of PCT/KR2022/002845, filed February 28, 2022, which claims priority to foreign applications KR10-2021-0116499, filed September 1, 2021, and KR10-2022-0000933, filed January 4, 2022. Claims 27-41 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted April 1, 2024 is acknowledged wherein claims 1-26 are canceled and new claims 27-41 are introduced.
Information Disclosure Statement
The information disclosure statements submitted September 29, 2022, August 8, 2023, and December 20, 2024, are acknowledged. The document KR10-2011-0138986 appears twice in the listing of foreign documents in the 9/29/2022 IDS. Therefore the duplicate citation has been struck through and the document only considered once.
Claim Objections
Claim 29 is objected to because of the following informalities: the grammatically incorrect phrase, “the derivative includes γ-cyclodextrin is substituted with hydroxypropyl.” This phrase is grammatically incorrect. 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.
Claims 27-41 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 methods of treating hyperlipidemia and diabetes mellitus, for example, does not reasonably provide enablement for the entire scope of diseases related to cholesterol metabolism dysregulation recited in independent claim 27, or to all of the specific diseases recited in dependent claim 30. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Nature of the invention: The claimed invention is directed to a method of preventing or alleviating a disease by administering a particular therapeutic agent to a subject. In order to be enabled for the full scope of the claims, one skilled in the art must, without having to engage in undue experimentation, have a reasonable expectation of successfully preventing or alleviating any disease with in the claimed scope.
The Breadth of the claims: The claimed invention encompasses methods of treating diseases which fall within the class of diseases “related to cholesterol metabolism dysregulation.” As described in the paragraph bridging pp. 8-9 of the present specification, this class of diseases is defined by accumulation of cholesterol in any tissues of the body, and in addition to well characterized cholesterol elevation in hyperlipidemia and diabetes, includes specific conditions as diverse as Niemann-pick disease type C, Alzheimer’s disease, Parkinson’s disease, focal segmental glomerulosclerosis, Alport syndrome, and so forth.
The state of the prior art: The prior art discloses various examples of antihyperlipidemic agents and their use in treating or preventing disease. For example, Hasimun et al. (Reference included with PTO-892) discloses that there is an ongoing attempt to develop agents to reduce hyperlipidemia in order to prevent or reduce cardiovascular complications. (p. 74 left column first paragraph) As described by Shrivastava et al., (Reference included with PTO-892) type 2 diabetes is associated with dyslipidemia, and control of lipid metabolism is a desired outcome. (p. 2258 right column) However, the prior art does not describe lipid-lowering agents as being universally effective for preventing or ameliorating every disease in which cholesterol metabolism is dysregulated. For example, according to Sitarska et al. (Reference included with PTO-892) Niemann-Pick disease type C is characterized by accumulation of cholesterol in lysosomes, and as a result antihyperlipidemic drugs have been used in an attempt to decrease accumulation of cholesterol. (p. 2216 left column second paragraph) However, these agents failed to improve brain pathology despite reducing cholesterol levels elsewhere in the body. Kuang (Reference included with PTO-892) discloses that studies of the link between satin use and dementia are contradictory and inconclusive. (pp. 3-5 section 3.2) Xicoy et al. (Reference included with PTO-892) similarly discloses that studies of the association between Parkinson’s disease and cholesterol have indicated contradictory correlation between both total cholesterol and statin use and risk of developing PD. (p. 23 section 6.1.1, p. 25 section 6.1.4) Therefore it is clear that the mere fact that a particular chemical compound is determine to be capable of reducing cholesterol levels in a human subject does not thereby enable one skilled in the art to treat all diseases which may be connected to dysregulation of cholesterol metabolism.
The relative skill of those in the art: The relative skill of those in the art is high.
The predictability or unpredictability of the art: As discussed under the heading “The breadth of the claims,” The scope of diseases treated by the claimed invention includes a wide number of only tangentially related conditions connected only in that cholesterol accumulation is observed in some tissue in patients suffering therefrom. As the human body is complex and includes large numbers of genes and metabolic pathways, the mere presence of one particular molecule in abnormal amounts in various diseases does not necessarily mean that all of these diseases share a common pathogenic mechanism or can be treated by a single therapeutic agent.
The amount of direction or guidance presented: Applicant’s disclosure describes the invention as being intended to remove cholesterol from a subject while not causing plasma membrane disruption or other adverse effects. (p. 2 first paragraph) The disclosure then suggests that administering these compounds would be useful for treating conditions wherein cholesterol accumulates in various tissues, and provides a number of examples. (paragraph bridging pp. 8-9) However, the disclosure does not further advance the state of the art in its understanding of the mechanisms or involvement of cholesterol in any of the recited diseases.
The presence or absence of working examples: Pp. 21-37 of the specification describe the synthesis and evaluation of gamma-cyclodextrin polymers. In particular, example 3 on pp. 24-25 describes gamma-cyclodextrin derivatives as extracting less cholesterol from plasma membranes than alpha- and beta- cyclodextrins. Furthermore examples 4-5 on pp. 25-26 disclose that gamma cyclodextrins possess low cytotoxicity and hemolytic activity in vitro. Examples 6-7 on pp, 27-31 disclose that a gamma-cyclodextrin polymer can promote dissolution of cholesterol and extract cholesterol form cells in culture. Examples 10-11 on pp. 33-37 describe administration of the claimed therapeutic agent to mice, which results in increased cholesterol excretion with low toxicity. In total, the working examples describe gamma-cyclodextrin polymers as safe for in vivo administration and capable of increasing cholesterol excretion from a subject. This would be expected by one of ordinary skill in the art to suggest that they are useful for reducing cholesterol levels and treating or ameliorating conditions such as atherosclerosis wherein it is known that cholesterol lowering agents are useful. However, the working examples do not provide any guidance for the treatment of other diseases such as Alzheimer’s disease or Niemann-Pick disease wherein it is not well established that simply lowering cholesterol has any beneficial effect.
The quantity of experimentation necessary: In order to practice the claimed therapeutic method for the full scope of the claims, one of ordinary skill in the art would have had to reasonably be able to treat or prevent any disease falling within the scope recited in independent claim 27 or dependent claim 30. As discussed above, the present disclosure describes the utility of gamma-cyclodextrin polymers for safely extracting cholesterol from cells and reducing cholesterol accumulation in vivo. However, as discussed under “the state of the art,” there is no basis in the prior art for any conclusion that agents that reduce cholesterol accumulation are universally effective in treating diseases wherein accumulation of cholesterol is a symptom. Therefore in order to treat the full scope of diseases included within the definition of claim 27 or the list recited in claim 30, one skilled in the art would have to undertake an involved process of original and unpredictable experimentation in order to determine what conditions can actually be treated in this manner and how such treatments can be carried out.
Genentech, 108 F.3d at 1366, sates that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” And “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
Therefore, in view of the Wands factors, as discussed above, particularly the scope of the claims and the unpredictability of the art, Applicants fail to provide information sufficient to practice the claimed invention for methods of treating the full scope of diseases claimed.
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 41 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.
This claim depends from claim 28, which claims a method comprising administering to a subject a gamma-cyclodextrin containing polymer, defined in the third paragraph of p. 4 of the specification as a polymer of two or more separate gamma-cyclodextrin subunits covalently linked to one another, for example by a crosslinking agent. Such a compound would necessarily require that each individual gamma-cyclodextrin monomer contain at least one covalent point of attachment either directly to another gamma-cyclodextrin or to anther molecule such as a linker or backbone. However, dependent claim 41 further defines the gamma-cyclodextrin monomer as formula 1, which is pictured as
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. In this claim, R, R’, and R” are all defined as hydrogen, alkyl, hydroxyalkyl, sulfobutylether alkyl, or carboxyalkyl. None are defined as a point of attachment to other polymer subunits or to a linker. While a bond is pictured between the C-1 and C-4 positions, this is merely the 1-4 linkage present in free gamma-cyclodextrin monomer. By contrast both claims 28 and 41 claim a method wherein the active agent is a polymer comprising multiple gamma-cyclodextrin subunits, which necessarily cannot be represented by a drawing of a single monomer wherein all of the potential points of attachment are already defined either as a hydrogen, an alkyl ether, or an internal bond within the cyclodextrin monomer. While such a monomer could represent a starting material for a process of making a polymer of gamma-cyclodextrin monomers, this structure could not represent any actual substructure of the polymer itself as it contains only a single gamma-cyclodextrin in contrast to base claim 28 which requires at least two gamma-cyclodextrin monomers be present in the structure. Therefore this claim is missing an essential element, namely any point of attachment to the rest of the polymer structure, rendering the claim indefinite.
Claim 32 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.
This claim refers to a number of different chemical names. Some of these names are listed as alphanumeric designations, for example T-314407. These names are not particularly defined in the specification in such a way as to connect them with a specific chemical structure. A review of the specific chemical names recited in claim 32 and the relevant descriptions in the art indicates that the names CRX000541, CRX000864, CRX000929, CRX000823, CRX000987, CRX001093, CRX001094, CRX156651, CRX000909, CRX000908, CRX000369, CRX001045, CRX001046, LN7181, LN7179, LN7172, LN6672, LN7031, LN7033, LN6500, LN6662, DY 136, and DY 142 are not recognized in the art as being a particular chemical entity whose identity would be evident to one skilled in the art and familiar with the state of the art. Therefore it is unclear what compounds are referred to by these structures, rendering the claim indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 41 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Independent claim 28, from which claim 41 depends, specifically claims a method comprising administering a polymer to a subject, wherein the polymer contains at least two gamma-cyclodextrin monomers. In such a polymer each monomer subunit must by necessity contain points of attachment whereby it is linked to other portions of the polymer. However, claim 41 specifically requires that the monomer have a particular formula referred to as formula 1, which is a depiction of a single gamma-cyclodextrin monomer and does not contain any such points of attachment by which it could be connected to additional gamma-cyclodextrin monomers as required by claim 28. Therefore claim 41 specifically excludes a structural feature required by base claim 28, thereby failing to include all the limitations of the base claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 27-30, 36, and 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni et al. (US pre-grant publication 2021/0102006, cited in PTO-1449)
Independent claim 27 is directed to a method for treating a disease related to cholesterol metabolism dysregulation comprising administering to a subject a composition comprising administering to a subject a gamma-cyclodextrin polymer having a molar mass between 2.5 and 50 kDa. Dependent claims 29 and 36 define the derivative of gamma cyclodextrin as hydroxypropyl-gamma-cyclodextrin. Dependent claim 39 describes the average mw as between about 3-40 kDa.
Kulkarni et al. discloses a method of treating a lysosomal lipid storage disease associated with NPC1 or NPC2 comprising administering to a subject in need thereof a polymer comprising a repeating unit of a cyclodextrin alternating with a linker. (p. 1 paragraphs 8-11) In one embodiment the cyclodextrin is gamma-cyclodextrin or a derivative thereof such as hydroxypropyl-gamma-cyclodextrin. (p. 1 paragraph 13) Kulkarni et al. further discloses that Niemann-Pick disease type C (NPC) is a disease characterized by the accumulation of cholesterol, thereby falling within the scope of diseases recited in present claim 27. (p. 1 paragraphs 4-5) In a preferred embodiment the number of cyclodextrin monomers is 15-35, for example 20-30. (p. 2 paragraph 30) Still further, Kulkarni et al, discloses a particular working embodiment having a molecular weight peak of 33.2 kDa, a degree of polymerization of approximately 25, and a polydispersity of approximately 1.021. (p. 20 paragraphs 273-273) While Kulkarni et al. does not specifically disclose an embodiment which is a gamma-cyclodextrin or hydroxypropyl-gamma-cyclodextrin polymer having the specific claimed molecular weight, it would have been obvious to one of ordinary skill in the art at the time of the invention to prepare such a polymer with the claimed molecular weight. In particular, the reference describes specific examples of beta cyclodextrin polymers having the recited molecular weight and a broad value of allowable degrees of polymerization. This would have guided one of ordinary skill in the art to prepare a gamma-cyclodextrin containing polymer at a similar degree of polymerization and molecular weight.
Regarding claims 28 and 40, as well as dependent claim 41, the recited ranges of numbers of cyclodextrin monomers substantially overlap with the ranges suggested by Kulkarni et al., such as 15-35 or 20-30. Therefore one of ordinary skill in the art would have found it to be obvious to make gamma-cyclodextrin polymers having the claimed degree of polymerization, since this is one of the variables that the art suggests optimizing to a similar range. Regarding dependent claim 30, Niemann-Pick type C is one of the specific diseases recited by this claim.
For these reasons the invention taken as a whole is prima facie obvious.
Claims 27-30, and 36-41 are rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni et al. as applied to claims 27-30, 36, and 39-41 above, and further in view of Era et al. (US pre-grant publication 2017/0216342, cited in PTO-1449)
The disclosure of Kulkarni et al. is discussed above. While as discussed previously, claims 27-30, 36, and 39-41 are considered to be obvious over Kulkarni et al. alone, even assuming for the sake of argument that Kulkarni et al. does not specifically render the use of hydroxypropyl-gamma-cyclodextrin as the monomer obvious, it would still have been obvious to one of ordinary skill in the art at the time of the invention to practice the claimed invention based on the disclosure of Era et al.
Era et al. discloses a method of treating a disease caused by cholesterol accumulation such as lysosomal storage diseases including Niemann-Pick disease and GM1 gangliosidosis. (p. 2 paragraph 21) In particular, Era et al. discloses a preferred embodiment comprising administering hydroxypropyl-gamma-cyclodextrin as the active therapeutic agent. (p. 6 paragraphs 99-101) One of ordinary skill in the art would therefore have found it to be obvious to use hydroxypropyl-gamma-cyclodextrin as the monomer in Kulkarni’s polymer, since this particular cyclodextrin is disclosed by Era et al. to be particularly useful for treating the same cholesterol accumulation diseases such as Niemann-Pick C.
Regarding claims 37 and 38, the particular hydroxypropyl-gamma-CD exemplified in this reference is described as having a degree of substitution of 6.4. (p. 10 paragraph 141) Since gamma-cyclodextrin has eight glucose subunits, this amounts to an average degree of substitution of 0.8 per glucose subunit. Interpreted in view of the present disclosure, for example the last paragraph of p. 5 and the first paragraph of p. 6, the “molar substitution” recited in present claims 37 and 38 appears to be the substitution per glucose subunit, which would therefore be infringed by the degree of substitution of Era’s cyclodextrin monomers. One of ordinary skill in the art would therefore have found it to be obvious to use the specific hydroxypropyl-gamma-cyclodextrin monomers having the degrees of substitution recited by Era et al. in Kulkarni’s polymers, in view of the fact that Era et al. specifically suggests these cyclodextrin derivatives of the same use.
For these reasons the invention taken as a whole is prima facie obvious.
Claims 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni et al. as applied to claims 27-30, 36, and 39-41 above, and further in view of Rudd et al. (PCT international publication WO2018/068295, Reference included with PTO-892) in view of Bennett et al. (Reference included with PTO-892)
The disclosure of Kulkarni et al. is discussed above. Kulkarni et al. does not specifically disclose a method further comprising administering a second active agent such as a liver-X receptor (LXR) agonist.
Rudd et al. discloses liver X agonists as therapeutic agents. (p. 2 lines 23-30) These compounds can be used in the treatment of diseases characterized by defects in cholesterol or lipid metabolism. (p. 5 line 22 – p. 6 line 2) Such diseases are described as including Niemann-Pick type C1. (p. 12 lines 21-26) It therefore would have been obvious to one of ordinary skill in the art at the time of the invention to administer the cyclodextrin polymer described by Kulkarni et al. in combination with one of the LXR agonists described by Rudd et al. One of ordinary skill in the art would have seen this to be obvious in view of the fact that both of these agents are described as usable for treating the same patient population.
With respect to claim 32, Bennett et al. discloses a number of different liver X receptor agonists, including some such as 24(S),25-epoxycholesterol, 24(S)-hydroxycholesterol, T-314407, and T-0901317, for example (p. 969 top of page) which are among those recited in claim 32. It would therefore have been obvious to one of ordinary skill in the art to administer these compounds in combination with Kulkarni’s cyclodextrin polymers, in view of the fact that Rudd describes LXR agonists as useful for treating this same condition. Furthermore it is also noted that Bennett discloses that a different researcher also discloses a different class of LXR agonists as also useful for treating Niemann-Pick disease, (p. 977 left column second paragraph) further suggesting that compounds having this activity are useful for treating this disease.
For these reasons the invention taken as a whole is prima facie obvious.
Claims 31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni et al. as applied to claims 27-30, 36, and 39-41 above, and further in view of Rakipovski et al. (Reference included with PTO-892)
The disclosure of Kulkarni et al. is discussed above. Kulkarni et al. does not specifically disclose a method further comprising administering a second active agent such as a GLP-1 agonist. However, Kulkarni et al. does disclose that the disclosed cyclodextrin polymers are useful for treating conditions including atherosclerosis. (p. 11 paragraph 181)
Rakipovski et al. discloses a study of the effects of the GLP-1 agonists liraglutide and semaglutide in mouse models of atherosclerosis. (p. 845 left column third paragraphs) These agents were found to inhibit the progression of atherosclerosis. (p. 848 left column last paragraph – p. 850 right column last paragraph)
It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to administer a GLP-1 agonist in combination with the cyclodextrin polymers described by Kulkarni et al., to a subject suffering from or at risk for atherosclerosis. One of ordinary skill in the art would have found this to be obvious because both active agents are disclosed to be useful for treating this same patient population.
For these reasons the invention taken as a whole is prima facie obvious.
Claims 31, 34, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni et al. as applied to claims 27-30, 36, and 39-41 above, and further in view of Wierzbicki et al. (Reference included with PTO-892)
The disclosure of Kulkarni et al. is discussed above. Kulkarni et al. does not specifically disclose a method further comprising administering a second active agent such as a statin or fibrate. However, Kulkarni et al. does disclose that the disclosed cyclodextrin polymers are useful for treating conditions including atherosclerosis. (p. 11 paragraph 181)
Wierzbicki et al. discloses that hyperlipidemia is a risk factor for atherosclerosis. (p. 156 left column first paragraph) Statins and fibrates are the two most commonly used drug classes to improve the lipid profile in such patients. (p. 157 left column second paragraph) Specific fibrates and statins are listed including those recited in present claims 34 and 35.
It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to administer a statin and/or fibrate in combination with the cyclodextrin polymers described by Kulkarni et al., to a subject suffering from or at risk for atherosclerosis. One of ordinary skill in the art would have found this to be obvious because both active agents are disclosed to be useful for treating this same patient population.
For these reasons the invention taken as a whole is prima facie 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 27-29 and 36-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-7 of U.S. Patent No. 11931376. (Cited in in PTO-892, herein referred to as ‘376)
Specifically claim 1 of ‘376 claims a method of reducing an amount of kidney cholesterol in a subject comprising administering to the subject a gamma cyclodextrin oligomer having a molecular weight between 2.5-20 kDa. Reducing kidney cholesterol is reasonably considered to be a method of treating a disease related to cholesterol metabolism dysregulation. The mw range of 2.5-20 kDa anticipates the range recited in present claim 27. Furthermore claim 6 of ‘376 defines the gamma-CD derivative as hydroxypropyl-gamma-CD, which falls within the scope of present claims 29, 36, and 41. Dependent claim 5 defines the oligomer as having between 2-10 monomers, which falls within present claims 28 and 40. Dependent claim 7 defines the degree of substitution as a value falling within the scope of claims 37 and 38. Finally, the mw range of claim 1 of ‘376 substantially overlaps the range recited in present claim 39, rendering said claim obvious.
Claims 27-30, 36, and 39-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 5, 7, and 11 of copending Application No. 19/276076 (reference application, unbpublished, cited in PTO-892, herein referred to as ‘076). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘076 render the present claims obvious.
Specifically, claim 1 of ‘076 claims a composition for prevention or treatment of disease caused by the toxic effects of cholesterol, comprising a copolymer comprising both beta- and gamma- cyclodextrin. This copolymer would reasonably be considered to fall within the scope of a gamma cyclodextrin polymer recited in present claim 27. Furthermore claim 2 of ‘076 defines the molecular weight as a range overlapping the range recited in present claims 27 and 39. Claim 11 of ‘076 claims a method comprising administering said copolymer to a subject suffering from a disease caused by the toxic effects of cholesterol. It would have been obvious to one of ordinary skill in the art to carry out such a method using a polymer having mw falling within the ranges recited in present claims 27 and 39. One of ordinary skill in the art would have found this to be obvious based on the fact that the ranges substantially overlap, and there would have been a reasonable expectation of success in determining the appropriate value of mw to use in the claimed method. Furthermore claim 4 recites a number of cyclodextrin monomers substantially overlapping with the range recited in present claims 28 and 40. Claim 5 of ‘076 defines the cyclodextrin as a hydroxypropyl cyclodextrin. Claim 7 describes the disease being treated as selected from a list including diseases recited in present claim 30.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed in this action.
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/ANDREA OLSON/Primary Examiner, Art Unit 1693 12/9/2025