Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Reissue: Non-Final Office Action
Status of the Claims
On 03/28/2019 US Patent 10,301,376 issued to Schiff et al. with claims 1-47. Claims 1-71 are currently pending, with claims 48-71 newly presented in the instant reissue application. Claims 1-65 are the subject of this Office Action. Non-elected claims 66-71 are withdrawn from consideration as discussed below.
This is the first Office Action on the merits of the claims in reissue Application 18/662,935.
Maintenance Fees
Applicant is reminded of the requirement to pay all applicable maintenance fees on the original patent. See MPEP § 1415.01.
Ongoing Duty To Disclose
Applicant(s) is/are reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent 10,301,376 is or was involved. These proceedings would include any trial at the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Information Disclosure Statement
The references cited on the information disclosure statement(s) were considered and have been made of record to the extent that each was provided.
Official Gazette Publication
The Official Gazette (O.G.) publication date for this reissue application was 06/11/2024.
Election by Original Presentation
Newly submitted (product) claims 66-71 are directed to inventions that are independent or distinct from the invention originally claimed for the following reasons:
The inventions for which restriction is required under 35 U.S.C. 121 are as follows:
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-65, drawn to a method of treating an IG-treatable disease, classified in A61P 37/00.
II. Claims 66-71, drawn to a kit and associated pharmaceutical composition, classified in C07K 16/06.
The inventions are distinct, each from the other because of the following reasons:
Inventions I and II 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 the product can be used in a different process, such as a prophylactic treatment in a subject without a disease, or as a diagnostic for assessing the presence of IG-recognized antigens.
Restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply (see MPEP § 803(II)):
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(d) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112(a).
Serious search burden exists because the inventions are classified in different classes/subclasses (CPC main groups and sub groups).
Since applicants have received an action on the merits for the originally presented invention (i.e., the method claims in application 12/381,844), this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, instant product claims 66-71 are withdrawn from consideration as being directed to non-elected inventions. See 37 CFR 1.142(b) and MPEP § 821.03.
Certificates of Correction
A. The '376 patent contains a certificate of correction dated 05/19/2020, but there is no copy of this document in the reissue application. Applicants are required to supply a copy of the certificate of correction. See 37 CFR 1.173(a)(1). Applicants must also supply a copy of the claims, including the changes made by the certificate of correction, without markings in this reissue application. See MPEP § 1411.01.
B. A certificate of correction is required in parent reissue application 17/332,776 (now RE49,967), as discussed below.
Multiple Reissue Applications
The instant case is a (reissue) CON of reissue application 17/332,766 (now RE49,967), which is a reissue of application 12/381,844 (issued as 10,301,376). 37 CFR 1.177(a) requires that all multiple reissue applications resulting from a single patent must include as the first sentence of their respective specifications a cross reference to the other reissue application(s). Accordingly, the first sentence of each reissue specification must provide notice stating that more than one reissue application has been filed, and it must identify each of the reissue applications and their relationship within the family of reissue applications, and to the original patent. An example of the suggested language to be inserted is as follows:
Notice: More than one reissue application has been filed for the reissue of Patent No. 99,999,999. The reissue applications are application number 99/999,994 (the present application); and application number 99/999,995, which is a continuation reissue of Patent No. 99,999,999.
See MPEP § 1451. Applicant should file a certificate of correction in the parent reissue (case 17/332,766; RE49,967) to inform the public of the presence of both applications.
Claim Objections
The claim set filed 09/12/2024 is objected to because the original claims are not presented with a status identifier. (See, e.g., claim 17.) The examiner requests that applicants label each claim, whether amended or not, with the appropriate status identifiers for clarity of the record.
Claim Rejections – 35 U.S.C. § 251
Recapture
The instant reissue application is a continuation (CON) of reissue application 17/332,776, which was filed on 05/27/2021, which is within two years of the issue date of US Patent 10,301,376 (issued on 05/28/2019); and has clear intent to broaden a claim.
Claims 1-65 are rejected under 35 U.S.C. 251 as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based.
A broadening aspect is present in the reissue application which was not present in the patent under reissue. The record of the application for the patent shows that the broadening aspect (in the reissue) relates to claimed subject matter that applicant previously surrendered during the prosecution of the application. Accordingly, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claim subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
See Greenliant Systems, Inc. et al v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Shahram Mostafazadeh and Joseph O. Smith, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984).
In accordance with MPEP 1412.02 (and case law cited therein) we apply the recapture rule as a three-step process:
(1) Determine whether, and in what respect, the reissue claims are broader in scope than the original patent claims.
(2) Determine whether the broader aspects of the reissue claims related to subject matter surrendered in the original prosecution; and
(3) Determine whether the reissue claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule.
In the instant case,
(1) Reissue claims 1-65 are broader in scope than the original patent claims.
Original (patented) claim 1 recited a method for treating an IG-treatable disease or condition comprising administering no more than once monthly a soluble hyaluronidase and an immune globulin (IG) wherein: the IG is from human plasma, the IG and hyaluronidase are administered separately, the hyaluronidase is administered prior to the IG. Claim 1 of the reissue broadens the "no more than once monthly" limitation to "once about every two weeks", for example. It also deletes the requirements that the IG is from human plasma, that the IG and hyaluronidase are administered separately, and that the hyaluronidase is administered prior to the IG. New independent claims 64 and 65 also delete these requirements, as well as eliminating any limitation regarding dosage frequency entirely. Claims 1, 64, and 65 are additionally broadened by adding the modifier "about" to the claimed ranges.
(2) The broader aspect of the reissue of claims 1-65 is related to subject matter surrendered in the original prosecution.
During prosecution of application 12/381,844 that issued as US Patent 10,301,376, the original version of claim 1 did not recite any of the limitations underlined in section (1) above (see the claim set dated 10/01/2009 in application 12/381,844). The Examiner rejected the claims over Bookbinder (US 2006/0104968) under 35 U.S.C. 102, and under 35 U.S.C. 103(a) in combination with other references (see the OA dated 05/09/2012). In order to overcome the rejections, applicants narrowed claim 1 by adding the limitation that the IG is from human plasma in the 09/11/2012 claims. On p. 12 of the 09/11/2012 response, applicants argued that the cited prior art does not teach an IG from human plasma. The Examiner maintained the rejection under 35 U.S.C. 103(a) (see the OAs dated 09/17/2013 and 03/27/2014). The limitations regarding administration "no more than once a month" and that the IG and hyaluronidase are administered separately were added in claim 103 in the 12/17/2013 claims. In order to overcome the rejection, applicants canceled claim 1 and made claim 103 the new independent claim (see the claims dated 08/28/2014). On pgs. 11-14 of the 12/17/2013 response, and on pgs. 12-13 of the 08/28/2014 response, applicants argued that the cited prior art does not teach once monthly administration of IG. On p. 14 of the 12/17/2013 response, and on pgs. 12-13 of the 08/28/2014 response, applicants argued that the cited prior art does not teach the separate administration of IG and hyaluronidase. The Examiner rejected the claims under 35 U.S.C. 103(a) (see the OAs dated 03/27/2014 and 09/11/2014). In order to overcome the rejection, applicants narrowed claim 103 by adding the limitation that the hyaluronidase is administered prior to the IG (see the claims dated 04/27/2015). On p. 7 of the 04/27/2015 response, applicants argued that the cited prior art does not teach a separate administration in which the hyaluronidase is administered first.
Prosecution proceeded with additional Office actions being issued, although no further claim amendments were made. Applicants repeatedly argued that the inserted limitations were critical to patentability. For example, in the 10/19/2018 appeal brief, applicants wrote that “[o]nly a low dose of hyaluronidase, administered before the IG, is needed to achieve sufficient bioavailability of the IG for administration as a single monthly dose.” (Brief at p. 6, emphasis added.) Applicants repeatedly referred to a “leading edge” regimen in which hyaluronidase is administered prior to—i.e., separately from—administration of the IG as rendering the claims nonobvious (e.g., see the Brief at pgs. 6, 17, 21, 22-23, 26, 28, 29, 32.). As such, the original patent claim limitations underlined in section (1) above were relied upon to gain allowance of the claims.
Thus, the amended claims presented with the instant reissue seek to recapture several features which are precisely the broader limitations that applicants surrendered in the prosecution of application 12/381,844, which application issued as US Patent 10,301,376, to gain the allowance of claims 1-47.
(3) There is no evidence of record that the reissue claims were materially narrowed in other respects so that the claims may not have been enlarged, and hence avoid the recapture rule.
The claims contain no limitations beyond the treatment method and therefore have not been materially narrowed relative to the patented claims.
Original Patent
The following is a quotation of the first paragraph of 35 U.S.C. 251:
(a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.
Claims 64-65 are rejected under 35 U.S.C. 251, for claiming subject matter that does not meet the original patent requirement.
MPEP 1412.01 states that the reissue claims must be for the same invention as that disclosed as being the invention of the original patent. MPEP 1412.01 further provides guidelines for determining whether the reissue claims are "for the invention disclosed in the original patent" as:
(A) the claims presented in the reissue application are described in the original patent specification and enabled by the original patent specification such that 35 U.S.C. 112, first paragraph is satisfied; and
(B) nothing in the original patent specification indicates an intent not to claim the subject matter of the claims presented in the reissue application; and
(C) the newly claimed invention is clearly and unequivocally disclosed in the specification as a separate invention with the claimed combination of features.
The presence of the disclosure in the original patent should evidence that applicant intended to claim or that applicant considered the material now claimed to be the invention.
Further, the Federal Circuit addressed the “original patent” requirement of 35 USC 251 in Antares Pharma, Inc. v. Medac Pharma Inc. and Medac GMBH, 771 F.3d 1354, 112 USPQ2d 1865 (Fed. Cir. 2014). In Antares the reissue claims covered embodiments of injection devices (not restricted to jet-injection devices) which the Applicant admitted was a different invention from what was originally claimed. Id. at 1356. The Federal Circuit adopted the Supreme Court's explanation of the “same invention” requirement as “if the original patent specification fully describes the claimed inventions, but not if the broader claims ‘are [] merely suggested or indicated in the original specification’ ”. Id. at 1359. The Federal Circuit further stated that although wording in 35 USC 251 was changed from “same invention” to “original patent” no change in substance was intended. Id. at 1360.
Based on Antares a review of the specification is necessary to determine whether the original specification adequately discloses the invention of the reissue claims.
In the instant case, the original patent required administration no more than once monthly in all claims, and even the first claims presented in application 12/381,844 required a dosage regimen and frequency substantially the same as for IV administration (see the 10/01/2009 claims in application 12/381,844). Additionally, the specification describes dosing frequency/regimen as a key feature (e.g., see the abstract, Summary at col. 2, lines 5-41, col. 5, lines 12-20; col. 7, lines 9-33; Examples), and the original application never clearly and unequivocally disclosed a method lacking a dosage frequency/regimen limitation. In fact, reducing the frequency of subcutaneous dosing appears to be the object of the invention (e.g., see col. 1, lines 59-62; col. 2, lines 16-19; col. 35, lines 41-49).
Thus, claims 64-65, which are directed to a method of treating an IG-treatable disease or condition lacking any dosage frequency/regimen limitation do not satisfy the “original patent” requirement, and are rejected under 35 USC 251 for not claiming subject matter directed to the invention disclosed in the original patent.
Claim Rejections - 35 USC § 112(a) (or pre-AIA , 1st Paragraph)
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-63 are rejected under 35 U.S.C. 112, first paragraph or 35 U.S.C. 112(a), 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(s), at the time the application was filed, had possession of the claimed invention.
Support is not found for the limitation "whereby the dose of IG administered is about 50%, about 75%, about 100%, or about 125% of an IG dose intravenously administered once about every 4 weeks". None of the portions cited by applicants as allegedly providing support for the changes to the claims (i.e., p. 1 of the 09/12/2024 remarks) sufficiently support this limitation. Neither the percentages claimed nor the linkages of these percentages to an IV dose about every 4 weeks appears to have sufficient support in the specification. Since this recitation is not properly supported in the specification as-filed, the claims are not afforded the benefit of an earlier filing date. Instead, the claims are afforded the date of 05/13/2024, the filing date of the instant reissue application.
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-13, 16-37, 40, 42, 43, 48, 56, and 60-63 are rejected under 35 U.S.C. 102(b) as being anticipated by MELAMED (Melamed, I. R., et al. J. Allergy Clin. Immunol. (2008), 121(2); S83; on IDS), as evidenced by Gammagard Liquid Prescribing Information.
Melamed reports that recombinant human hyaluronidase facilitates dispersion of subcutaneously administered Gammagard liquid (GGL, an immune globulin solution) and enables administration of a full monthly dose in a single site (title). Melamed teaches that compared to intravenous infusions, subcutaneous administration of gammaglobulin reduces the incidence of systemic reactions, does not require sometimes-difficult intravenous (iv) access, improves trough levels, and gives patients more independence. The main drawback is the need for multiple sites weekly due to the limited ability of tissue to accept large volumes. Recombinant human hyaluronidase (rHuPH20) transiently cleaves hyaluronic acid enzymatically in the subcutaneous tissue, facilitating dispersion of solutions (Rationale).
Melamed discloses a study to determine the amount of enzyme required to enable a monthly dose of Gammagard Liquid 10% (reads on the claimed concentration of IG) to be infused in a single site at rates equivalent to iv infusions. Eleven immunodeficient patients were infused (subcutaneously) with varying amounts of rHuPH20 with one, two, three, and four week doses of GGL (Methods). Ten of the patients achieved monthly doses of 25.5 to 61.2 grams (255 to 612 ml) in a single site, at rates of 120 to 300 ml/hr. A minimum of 50 U rHuPH20/gm GGL (reads on the claimed ratio of hyaluronidase to IG) was required to achieve these rates. The ten patients completing the study experienced only mild local reactions, such as swelling and redness; no drug-related allergic reactions occurred (Results). Melamed concludes that rHuPH20 enabled single site subcutaneous administration of a monthly dose of more than 400 mg/kg (reads on the instantly claimed dosage of about 100 mg/kg to about 2 g/kg BW) (Conclusions).
Regarding claims 3 and 19, rHuPH20 is identical to instant SEQ ID NO: 4.
Regarding claims 22-25 and 27-30, Gammagard Liquid is a formulation of IgG that is purified from human plasma by ethanol fractionation and ion exchange chromatography, has a pH of 4.6-5.1, and contains glycine as a stabilizing and buffering agent (prescribing information, p. 18).
Regarding claim 26, Gammagard Liquid contains at least 98% IgG, with only trace amounts of IgA (i.e., greater than 95% IgG) (prescribing information, pgs. 9 and 18).
Regarding claim 62, rHUPH20 (SEQ ID NO: 4) is a 447 amino acid protein, which lacks the 19-amino-acid glycosylphophatidyl inositol (GPI) anchor at the C-terminus (residues 491-509) according to par. [0165] of the instant specification.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 14, 15, 39, 41, 51-53, 59, 64, and 65 are rejected under 35 U.S.C. 103(a) as being unpatentable over MELAMED (Melamed, I. R., et al. J. Allergy Clin. Immunol. (2008), 121(2); S83) in view of BOOKBINDER (US 2006/0104968; Pub. May 18, 2006; on IDS).
The teachings of Melamed are presented supra, and are incorporated herein. Melamed does not teach the volume of the hyaluronidase, administration of the hyaluronidase prior to the IG, or the amounts of the hyaluronidase instantly claimed.
Bookbinder discloses soluble human neutral active hyaluronidase glycoproteins (sHASEGPs) in pharmaceutical compositions singularly and in combination with pharmacologics, such as immune globulins for medical applications ([0020], [0024], [0447], [0449], [0162], [0625], [0626], [0629]). Bookbinder teaches that the sHASEGPs open channels in the interstitial space through degradation of glycosaminoglycans that permit the diffusion of molecules such as proteins (including antibodies) ([0051], [0069]-[0070]). The hyaluronidase compositions can be administered subcutaneously ([0052], [0054], [0071], [0551]-[0552], [0589]; Example 20).
Regarding claims 14-15, Bookbinder teaches the volume for sHASEGP delivery can range from less than 0.1 ml to greater than 100 ml, such as 0.5 to 20 ml. Bookbinder teaches optimizing the volume, which will depend on the site of injection and desired delivery effects ([0091], [0425]).
Regarding claims 39 and 59, Bookbinder teaches the hyaluronidase can be administered prior to (e.g., 5 to 60 minutes before) the pharmacologic agent ([0068], [0439], [0591]; claims 86, 282).
Regarding claims 41, 51-53, 64, 65, Bookbinder teaches concentrations of hyaluronidase in the range of 1-5000 Units in volumes such as 5-50 µl, which overlaps the claimed range (e.g., 10 Units in 50 µl = 0.2 U/µl = 200 U/ml) ([0459]). Bookbinder also teaches concentrations of 10-200 U/ml ([0424], [0511], [0537]). Bookbinder teaches optimizing the concentration of hyaluronidase ([0072], [0078], [0089], [0106], [0495], [0651]). Further regarding claim 41, Melamed makes clear that 50 U rHuPH20/gm GGL is a minimum concentration, and using a higher amount of hyaluronidase (e.g., such as within the range taught by Bookbinder) would be obvious to one of skill in the art.
Claim 38 is rejected under 35 U.S.C. 103(a) as being unpatentable over MELAMED (Melamed, I. R., et al. J. Allergy Clin. Immunol. (2008), 121(2); S83) and BOOKBINDER (US 2006/0104968; Pub. May 18, 2006) as applied to claims 14, 15, 39, 41, 51-53, 59, 64, and 65, and further in view of KEATON (US 2008/0177234; Priority to Nov. 21, 2006).
The teachings of Melamed and Bookbinder are presented supra, and are incorporated herein. The references do not teach infusion by gravity.
However, Keaton discloses an infusion set for subcutaneous delivery of fluid medications (title; abstract). Keaton teaches that most systems for subcutaneous infusion operate by gravity or by an infusion pump ([0005]).
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art to have used either gravity or an infusion pump to subcutaneously deliver the liquid formulations of Melamed.
Claims 44-47, 57, and 58, are rejected under 35 U.S.C. 103(a) as being unpatentable over MELAMED (Melamed, I. R., et al. J. Allergy Clin. Immunol. (2008), 121(2); S83) and BOOKBINDER (US 2006/0104968; Pub. May 18, 2006) as applied to claims 14, 15, 39, 41, 51-53, 59, 64, and 65, and further in view of ORANGE (Orange, J. S., et al. J. Allergy Clin. Immunol. (2006), 117(4 Suppl); S525-S553).
The teachings of Melamed and Bookbinder are presented supra, and are incorporated herein. The references do not expressly teach the specific IgG treatable conditions instantly claimed. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat any IgG treatable disease with IgG using the general methods of Melamed.
For example Orange reviews the use of IgG in human disease (title; abstract). Orange teaches a wide variety of diseases and conditions are known to be treatable with IgG including primary immunodeficiencies (e.g., common variable immunodeficiency, CVID), hypogammaglobulinemia, polymyositis, cytomegalovirus (CMV), hepatitis, influenza, and demyelinating polyneuropathy (p. S528, 1st col.; p. S527, Table I; p. S528, 1st col.; p. S529, 1st col.; p. S530, Table IV; p. S532, 2nd col.; p. S534, Table V; p. S536).
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art to have treated any known IgG treatable disease or condition using the methods of administering IgG taught by Melamed and Bookbinder.
Claims 49 and 50 are rejected under 35 U.S.C. 103(a) as being unpatentable over MELAMED (Melamed, I. R., et al. J. Allergy Clin. Immunol. (2008), 121(2); S83) and BOOKBINDER (US 2006/0104968; Pub. May 18, 2006) as applied to claims 14, 15, 39, 41, 51-53, 59, 64, and 65, and further in view of PARKKINEN (WO 2005/072772; Pub. Aug. 11, 2005).
The teachings of Melamed and Bookbinder are presented supra, and are incorporated herein. The references do not expressly teach the specific % of IgG recited in claims 49-50. However, these amounts of IgG are standard in the art.
For example Parkkinen discloses liquid compositions of antibodies such as IgG for parenteral (e.g., subcutaneous) delivery (title; abstract). Parkkinen teaches the immunoglobulin is generally recovered in a concentration of 1-250 g/l and conventionally used in the range of 10-259 g/l for subcutaneous delivery (p. 8, lines 4-12). Note that 200 g/l = 20%.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art to have used the IgG in a concentration from about 10-20%, as is conventional in the art (per Parkkinen).
Claims 54 and 55 are rejected under 35 U.S.C. 103(a) as being unpatentable over MELAMED (Melamed, I. R., et al. J. Allergy Clin. Immunol. (2008), 121(2); S83) and BOOKBINDER (US 2006/0104968; Pub. May 18, 2006) as applied to claims 14, 15, 39, 41, 51-53, 59, 64, and 65, and further in view of BAKER (US 2011/0053247; Priority to Mar. 6, 2008; on IDS).
The teachings of Melamed and Bookbinder are presented supra, and are incorporated herein. The references do not expressly teach SEQ ID NO: 9. However, this sequence was known prior to the instant invention.
For example Baker discloses soluble hyaluronidases (title; abstract). Baker teaches SEQ ID NO: 9, which is identical to instant SEQ ID NO: 9 ([0049], [0055]).
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art to have used a known soluble hyaluronidase (such as any of those disclosed by Baker in the methods of Melamed.
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 obviousness-type 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); and 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
US Patent RE49,967
Claims 1-65 are non-provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-79 of US Patent RE49,967. Although the conflicting claims are not identical, they are not patentably distinct from each other because the '967 claims anticipate the instant claims. The difference between the two claim sets is that the '967 claims recite narrower limitations than the instant claims (e.g., the IG is from human plasma, the IG and hyaluronidase are administered separately, and the hyaluronidase is administered prior to the IG). However, the '967 claims recite the IG composition has a protein concentration that is 5-25 w/v IG, the IG is administered at a dosage of 100 mg/kg to 2 g/kg BW, and the hyaluronidase is administered at a ratio of 10-500 U hyaluronidase per gram of the IG, whereby a full monthly dose is administered. The recitation that a full monthly dose is administered is considered to read on the instant limitation that the dose of IG administered is from about 50% to about 125% of an IG dose IV administered once about every 4 weeks, as this is another way of describing a full monthly dose. Thus, the instant claims are anticipated by the '967 claims.
Relevant Prior Art Not Relied Upon
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
GARDULF (Gardulf, A., et al. J. Clin. Immunol. (2006), 26(2); 177-185)-Gardulf reports on rapid subcutaneous IgG replacement therapy in human subjects with primary immunodeficiencies which is effective and safe using weekly administration at the same monthly cumulative dose (400 mg/kg) of Vivaglobin® (ZLB Behring human plasma derived 96% IgG, 2.25% glycine amino acid) 16% (160 mg/ml) pH 7.0 IgG administered weekly at 100 mg/kg for approximately a year.
Conclusion
Claims 1-65 are rejected. No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kevin S Orwig whose telephone number is (571)270-5869. The examiner can normally be reached Mon.-Fri. 8AM-5PM.
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/Kevin S Orwig/
Patent Reexamination Specialist, Art Unit 3991
Conferees:
/LBD/ Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/ SPRS, Art Unit 3991
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